## Protocol Section
### Identification Module
**NCT ID:** NCT01879579

**Acronym:** MITI

**Brief Title:** Mobile Insulin Titration Intervention

**Official Title:** The Mobile Insulin Titration Intervention (MITI) Study: Innovative Chronic Disease Management of Diabetes

#### Organization Study ID Info
**ID:** S12-03713
#### Organization
**Class:** OTHER
**Full Name:** NYU Langone Health
#### Secondary ID Infos
**ID:** UL1TR000038
**Link:** https://reporter.nih.gov/quickSearch/UL1TR000038
**Type:** NIH
### Status Module
#### Completion Date
**Date:** 2015-06

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2015-10-12

**Type:** ESTIMATED

**Last Update Submit Date:** 2015-09-15

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2015-03

**Type:** ACTUAL

#### Results First Post Date
**Date:** 2015-10-12

**Type:** ESTIMATED

**Results First Submit Date:** 2015-08-11

**Results First Submit QC Date:** 2015-09-15

#### Start Date
**Date:** 2013-06

**Status Verified Date:** 2015-09

#### Study First Post Date
**Date:** 2013-06-18
**Type:** ESTIMATED
**Study First Submit Date:** 2013-06-13
**Study First Submit QC Date:** 2013-06-13
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** New York City Health and Hospitals Corporation

#### Lead Sponsor

**Class:** OTHER

**Name:** NYU Langone Health

#### Responsible Party

**Investigator Affiliation:** NYU Langone Health

**Investigator Full Name:** Natalie Levy

**Investigator Title:** Assistant Professor of Medicine

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** True

### Description Module

**Brief Summary:** The purpose of this pilot study is to determine whether text message (and phone) communication can be effectively utilized to adjust long-acting insulin, compared to standard practice.

**Detailed Description:** The current practice of insulin titration for diabetics requires multiple in-person clinic visits, during which a patient's long-acting insulin dose is adjusted until the optimal dose to control glycemia is reached. Finding this optimal dose can take weeks in an ideal setting, but often takes much longer in a busy urban clinic such as Bellevue Hospital Center. Relaying titration instructions to patients via phone and text message has the potential to decrease the titration timeline, thus reducing the number of clinic visits and the time it takes patients to reach their target blood glucose levels.

For this pilot project, study staff will recruit patients who are initiating long-acting insulin treatment or initiating the titration of their existing long acting insulin treatment at Bellevue Hospital Center's Adult Primary Care Center. Patients who volunteer to enroll and provide informed consent will be randomized to one of two arms (MITI or current best practice arm) at the time of enrollment and stratified by whether the patient is initiating insulin treatment or initiating the titration of his/her existing insulin dose. The study staff will provide a cell phone (for temporary use) to any patients who are randomized to the MITI arm and don't own a personal cell phone (or whose personal cell phone is not able to receive the Sense Health text messages). Patients will use the cell phone free of cost to participate in the intervention (receive Sense Health text messages, send their fasting blood glucose levels, and speak with the diabetes nurse and study staff.)

Patients in the MITI arm will receive automated text messages 5 weekdays per week, for up to 12 weeks, from Sense Health. These text messages will request the patient's fasting blood glucose level. The patient will reply with his/her fasting blood glucose value, which will be logged in password-protected accounts on www.sensehealth.com. The clinic's diabetes nurses will check each patient's fasting blood glucose level on www.sensehealth.com each weekday and call any patient with fasting blood glucose values \< 80 mg/dL and \> 400 mg/dL. Each Thursday, patients will receive a phone call from a nurse, who will adjust the patient's insulin dose according to the study titration protocol. Each patient will continue to receive daily text messages and weekly phone calls until the first of three events occur: the patient reaches his/her optimal insulin dose for achieving glycemic control, 12 weeks elapse, or the patient withdraws from the study.

Patients in the current best practice arm (CBP) will attend scheduled clinic appointments during which a provider will review the patient's fasting blood glucose log and titrate the insulin dose according to current best practice.

Patients in both arms will continue receiving routine care, including HbA1c values every 3 months and other routine labs and measures as per standard of care.

### Conditions Module

**Conditions:**

- Diabetes Mellitus

**Keywords:**

- Insulin

- Telemedicine

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 61

**Type:** ACTUAL

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.

**Intervention Names:**

- Other: Mobile Insulin Titration Intervention

**Label:** Mobile Insulin Titration Intervention

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.

**Label:** Current Best Practice

**Type:** NO_INTERVENTION

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Mobile Insulin Titration Intervention

**Description:** Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration.

**Name:** Mobile Insulin Titration Intervention

**Type:** OTHER

### Outcomes Module

#### Other Outcomes

**Description:** The number of text message replies from participants compared to the total number of text messages sent to participants (asking for blood glucose values). This outcome is given as a percent.

**Measure:** Percentage of Text Message Responses

**Time Frame:** 12 weeks

**Description:** The number of successful insulin titration phone calls compared to the total number of insulin titration phone calls assigned to the nurse. Successful phone calls are defined as when the nurse was able to reach the participant with one call attempt, two call attempts, or by voicemail. This outcome is given as a percent.

**Measure:** Percentage of Successful Phone Calls

**Time Frame:** 12 weeks

**Description:** The number of medication refill, emergency department, and walk-in clinic visits at Bellevue Hospital (non-insulin titration visits).

**Measure:** Patient Healthcare Utilization

**Time Frame:** 12 weeks

**Description:** Provider time spent on insulin titration visits by phone compared to insulin titration visits in the clinic.

**Measure:** Costs - Provider Time Spent on Insulin Titration Visits

**Time Frame:** 12 weeks

**Description:** The number of insulin titration visits (whether by phone or in the clinic).

**Measure:** Costs - Titration Visit Information

**Time Frame:** 12 weeks

**Description:** The time it took patients to travel to Bellevue Hospital, reported by patients in both study arms at baseline and at any subsequent clinic visits.

**Measure:** Costs - Patient Travel Time

**Time Frame:** 12 weeks

**Description:** At baseline, participants in both study arms (MITI and CBP) reported whether they had to pay co-pays for clinic visits at Bellevue Hospital.

**Measure:** Costs - Co-pays

**Time Frame:** baseline

**Description:** The study staff will interview MITI arm patients, using free-response questions, to assess their satisfaction with the intervention. The interviews will take place in person or over the phone at the patient's convenience, after the patient has reached his/her optimal insulin dose. If the patient does not reach optimal insulin dose, the interview will take place at approximately 12 weeks.

**Measure:** Qualitative Patient Satisfaction Interview

**Time Frame:** After patient reaches optimal insulin dose or at 12 weeks

#### Primary Outcomes

**Measure:** Percentage of Subjects Who Reach Optimal Long-acting Insulin Dose

**Time Frame:** 12 weeks

#### Secondary Outcomes

**Description:** The time it takes a patient to reach his/her optimal long-acting insulin dose will be measured for both study arms.

**Measure:** Time to Reach Optimal Long-acting Insulin Dose

**Time Frame:** 12 weeks

**Description:** Change in hemoglobin A1c

**Measure:** Hemoglobin A1c

**Time Frame:** baseline, 12 weeks (approximately 3 months)

**Description:** The Diabetes Treatment Satisfaction Questionnaire standard (DTSQs) will be used to measure the patient's satisfaction with diabetes treatment received prior to study participation. Scores on questionnaire range from 0 to 6: 0 = very dissatisfied, 6 = very satisfied.

**Measure:** Baseline Treatment Satisfaction

**Time Frame:** baseline

**Description:** The Diabetes Treatment Satisfaction Questionnaire standard (DTSQs) will be used to measure the patient's satisfaction with diabetes treatment received since initiation of long-acting insulin titration. Scores on questionnaire range from 0 to 6: 0 = very dissatisfied, 6 = very satisfied.

**Measure:** Treatment Satisfaction After Initiation of Insulin Titration

**Time Frame:** 12 weeks (approximately 3 months)

**Description:** The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) will be used to measure the change in the patient's satisfaction with his/her diabetes treatment since initiation of long-acting insulin titration. Scores on questionnaire range from -3 to +3: -3 = much less satisfied now, +3 = much more satisfied now.

**Measure:** Change in Treatment Satisfaction

**Time Frame:** 12 weeks (approximately 3 months)

**Description:** The number of instances of hypoglycemia as indicated by fasting blood glucose levels or symptoms reported by patients in both study arms.

**Measure:** Incidence of Hypoglycemia

**Time Frame:** 12 weeks

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Initiating long-acting insulin treatment or initiating the titration of long-acting insulin treatment
* Speaks English or Spanish
* Hemoglobin A1c \> or = 8%
* Able and willing to inject insulin
* Able and willing to provide informed consent

Exclusion Criteria:

* Short-acting insulin treatment
* Systemic glucocorticoids
* Sustained elevated serum creatinine \> or = 1.5 mg/dL for men and \> or = 1.4 mg/dL for women
* Hypoglycemia unawareness
* Type 1 diabetes

**Maximum Age:** 70 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** New York

**Country:** United States

**Facility:** Adult Primary Care Clinic, Bellevue Hospital Center

**State:** New York

**Zip:** 10016

#### Overall Officials

**Official 1:**

**Affiliation:** NYU Langone Health

**Name:** Natalie Levy, MD

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### References

**Citation:** Riddle MC, Rosenstock J, Gerich J; Insulin Glargine 4002 Study Investigators. The treat-to-target trial: randomized addition of glargine or human NPH insulin to oral therapy of type 2 diabetic patients. Diabetes Care. 2003 Nov;26(11):3080-6. doi: 10.2337/diacare.26.11.3080.

**PMID:** 14578243

**Citation:** Davies M, Storms F, Shutler S, Bianchi-Biscay M, Gomis R; ATLANTUS Study Group. Improvement of glycemic control in subjects with poorly controlled type 2 diabetes: comparison of two treatment algorithms using insulin glargine. Diabetes Care. 2005 Jun;28(6):1282-8. doi: 10.2337/diacare.28.6.1282.

**PMID:** 15920040

**Citation:** Davies M, Lavalle-Gonzalez F, Storms F, Gomis R; AT.LANTUS Study Group. Initiation of insulin glargine therapy in type 2 diabetes subjects suboptimally controlled on oral antidiabetic agents: results from the AT.LANTUS trial. Diabetes Obes Metab. 2008 May;10(5):387-99. doi: 10.1111/j.1463-1326.2008.00873.x. Epub 2008 Mar 18.

**PMID:** 18355327

**Citation:** Blonde L, Merilainen M, Karwe V, Raskin P; TITRATE Study Group. Patient-directed titration for achieving glycaemic goals using a once-daily basal insulin analogue: an assessment of two different fasting plasma glucose targets - the TITRATE study. Diabetes Obes Metab. 2009 Jun;11(6):623-31. doi: 10.1111/j.1463-1326.2009.01060.x.

**PMID:** 19515182

**Citation:** Arora S, Peters AL, Agy C, Menchine M. A mobile health intervention for inner city patients with poorly controlled diabetes: proof-of-concept of the TExT-MED program. Diabetes Technol Ther. 2012 Jun;14(6):492-6. doi: 10.1089/dia.2011.0252. Epub 2012 Apr 23.

**PMID:** 22524591

**Citation:** Walker EA, Shmukler C, Ullman R, Blanco E, Scollan-Koliopoulus M, Cohen HW. Results of a successful telephonic intervention to improve diabetes control in urban adults: a randomized trial. Diabetes Care. 2011 Jan;34(1):2-7. doi: 10.2337/dc10-1005.

**PMID:** 21193619

**Citation:** Levy N, Moynihan V, Nilo A, Singer K, Bernik LS, Etiebet MA, Fang Y, Cho J, Natarajan S. The Mobile Insulin Titration Intervention (MITI) for Insulin Adjustment in an Urban, Low-Income Population: Randomized Controlled Trial. J Med Internet Res. 2015 Jul 17;17(7):e180. doi: 10.2196/jmir.4716.

**PMID:** 26187303

**Citation:** Levy N, Moynihan V, Nilo A, Singer K, Bernik LS, Etiebet MA, Fang Y, Cho J, Natarajan S. The Mobile Insulin Titration Intervention (MITI) for Insulin Glargine Titration in an Urban, Low-Income Population: Randomized Controlled Trial Protocol. JMIR Res Protoc. 2015 Mar 13;4(1):e31. doi: 10.2196/resprot.4206. Erratum In: JMIR Res Protoc. 2015 Dec 21;4(4):e138.

**PMID:** 25794243

## Derived Section

### Condition Browse Module - Browse Branches

- Abbrev: BC18

- Name: Nutritional and Metabolic Diseases

- Abbrev: BC19

- Name: Gland and Hormone Related Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: M6147

- Name: Chronic Disease

- Relevance: LOW

- As Found: Unknown

- ID: T1303

- Name: Chronic Graft Versus Host Disease

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Ancestors

- ID: D000007004

- Term: Hypoglycemic Agents

- ID: D000045505

- Term: Physiological Effects of Drugs

### Intervention Browse Module - Browse Branches

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M10365

- Name: Insulin

- Relevance: HIGH

- As Found: Day 1

- ID: M173166

- Name: Insulin, Globin Zinc

- Relevance: LOW

- As Found: Unknown

- ID: M10054

- Name: Hypoglycemic Agents

- Relevance: LOW

- As Found: Unknown

### Intervention Browse Module - Meshes

- ID: D000007328

- Term: Insulin

### Misc Info Module

- Version Holder: 2024-05-24

## Results Section

### Adverse Events Module

**Description:** We were able to assess serious adverse events for participants who completed the allocated intervention (and the participant who discontinued insulin early due to a mild possible allergy). No serious adverse events were found.

#### Event Groups

**Group ID:** EG000

**Title:** Mobile Insulin Titration Intervention

**Description:** Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.

Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration.

**ID:** EG000

**Other Num Affected:** 3

**Other Num at Risk:** 28

**Serious Number At Risk:** 28

**Title:** Mobile Insulin Titration Intervention

**Group ID:** EG001

**Title:** Current Best Practice

**Description:** Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.

**ID:** EG001

**Other Num Affected:** 3

**Other Num at Risk:** 27

**Serious Number At Risk:** 27

**Title:** Current Best Practice

**Frequency Threshold:** 0

#### Other Events

**Term:** mild hypoglycemia

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

**Term:** mild possible allergy to insulin

**Assessment Type:** NON_SYSTEMATIC_ASSESSMENT

**Organ System:** General disorders

**Source Vocabulary:** 

## Results Section - Baseline Characteristics Module

### Denomination Counts

**Group ID:** BG000

**Value:** 33

**Group ID:** BG001

**Value:** 28

**Group ID:** BG002

**Value:** 61

**Units:** Participants

### Group

**ID:** BG000

**Title:** Mobile Insulin Titration Intervention

**Description:** Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.

Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration.

### Group

**ID:** BG001

**Title:** Current Best Practice

**Description:** Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.

### Group

**ID:** BG002

**Title:** Total

**Description:** Total of all reporting groups

### Measure

#### Measurement

**Group ID:** BG000

**Spread:** 11.22

**Value:** 48.48

#### Measurement

**Group ID:** BG001

**Spread:** 9.97

**Value:** 44.61

#### Measurement

**Group ID:** BG002

**Spread:** 10.75

**Value:** 46.70

**Class Title:** 

### Measure

#### Measurement

**Group ID:** BG000

**Value:** 15

#### Measurement

**Group ID:** BG001

**Value:** 16

#### Measurement

**Group ID:** BG002

**Value:** 31

**Category Title:** Female

#### Measurement

**Group ID:** BG000

**Value:** 18

#### Measurement

**Group ID:** BG001

**Value:** 12

#### Measurement

**Group ID:** BG002

**Value:** 30

**Category Title:** Male

**Class Title:** 

**Denomination Units Selected:** 

## Results Section - Baseline Characteristics Module

### Measure 1
**Dispersion Type:** STANDARD_DEVIATION
**Parameter Type:** MEAN
**Title:** Age, Continuous
**Unit of Measure:** years
### Measure 2
**Parameter Type:** COUNT_OF_PARTICIPANTS
**Title:** Sex: Female, Male
**Unit of Measure:** Participants
## Results Section - More Information Module
### Certain Agreement
**PI Sponsor Employee:** True
### Point of Contact
**Email:** Natalie.Levy@nyumc.org
**Organization:** New York University School of Medicine
**Phone:** 2122638924
**Title:** Dr. Natalie Levy
## Results Section - Outcome Measures Module
### Outcome Measure 1
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** <0.0001
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Chi-squared
**Tested Non-Inferiority:** False
### Outcome Measure 2
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.007
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Interval-censoring survival analysis
**Tested Non-Inferiority:** False
### Outcome Measure 3
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.99
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon rank-sum test
**Tested Non-Inferiority:** False
### Outcome Measure 4
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.78
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon rank-sum test
**Tested Non-Inferiority:** False
### Outcome Measure 5
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.04
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon rank-sum test
**Tested Non-Inferiority:** False
### Outcome Measure 6
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.13
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon rank-sum test
**Tested Non-Inferiority:** False
### Outcome Measure 7
### Outcome Measure 8
### Outcome Measure 9
### Outcome Measure 10
### Outcome Measure 11
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.008
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Generalized estimating equation modeling
**Tested Non-Inferiority:** False
### Outcome Measure 12
#### Analysis
**CI Lower Limit:** 
**CI Number of Sides:** TWO_SIDED
**CI Percentage Value:** 
**CI Upper Limit:** 
**CI Upper Limit Comment:** 
**Dispersion Type:** 
**Dispersion Value:** 
**Estimate Comment:** 
**Group Description:** 
**Non-Inferiority Comment:** 
**Non-Inferiority Type:** SUPERIORITY_OR_OTHER
**Other Analysis Description:** 
**P-Value:** 0.003
**P-Value Comment:** 
**Parameter Type:** 
**Parameter Value:** 
**Statistical Comment:** 
**Statistical Method:** Wilcoxon rank-sum test
**Tested Non-Inferiority:** False
### Outcome Measure 13
### Outcome Measure 14
### Outcome Measure 15
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 88
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 37
**Title:** 
#### Outcome Measure 2
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 1.29
- **Spread:** 
- **Upper Limit:** 4.86
- **Value:** 3.00
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 2.96
- **Spread:** 
- **Upper Limit:** 9.61
- **Value:** 7.07
**Title:** 
#### Outcome Measure 3
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 2.64
- **Upper Limit:** 
- **Value:** -1.90
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 2.63
- **Upper Limit:** 
- **Value:** -1.81
**Title:** 
#### Outcome Measure 4
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 1.14
- **Upper Limit:** 
- **Value:** 4.99
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.61
- **Upper Limit:** 
- **Value:** 5.20
**Title:** 
#### Outcome Measure 5
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.54
- **Upper Limit:** 
- **Value:** 5.74
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.52
- **Upper Limit:** 
- **Value:** 5.53
**Title:** 
#### Outcome Measure 6
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 0.71
- **Upper Limit:** 
- **Value:** 2.71
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 0.95
- **Upper Limit:** 
- **Value:** 2.42
**Title:** 
#### Outcome Measure 7
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 3
**Title:** 
#### Outcome Measure 8
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 84
**Title:** 
#### Outcome Measure 9
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 91
**Title:** 
#### Outcome Measure 10
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 11
**Title:** 
#### Outcome Measure 11
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 3
- **Spread:** 
- **Upper Limit:** 10
- **Value:** 6
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 20
- **Spread:** 
- **Upper Limit:** 45
- **Value:** 30
**Title:** 
#### Outcome Measure 12
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 2
- **Spread:** 
- **Upper Limit:** 5
- **Value:** 3.5
- **Comment:** 
- **Group ID:** OG001
- **Lower Limit:** 1
- **Spread:** 
- **Upper Limit:** 3
- **Value:** 2
**Title:** 
#### Outcome Measure 13
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 30
- **Spread:** 
- **Upper Limit:** 60
- **Value:** 45
**Title:** 
#### Outcome Measure 14
**Class:**
##### Category
**Measurements:**
- **Comment:** 
- **Group ID:** OG000
- **Lower Limit:** 
- **Spread:** 
- **Upper Limit:** 
- **Value:** 37
**Title:** 
#### Outcome Measure 15
## Results Section
### Outcome Measures Module
#### Outcome Measure 1
**Parameter Type:** NUMBER
**Population Description:** No primary outcome data available for one participant in Current Best Practice arm who discontinued insulin early due to a mild possible allergy.
**Reporting Status:** POSTED
**Time Frame:** 12 weeks
**Title:** Percentage of Subjects Who Reach Optimal Long-acting Insulin Dose
**Type:** PRIMARY
**Unit of Measure:** percentage of participants
##### Group
**Description:** Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.

Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration.
**ID:** OG000
**Title:** Mobile Insulin Titration Intervention
##### Group
**Description:** Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
**ID:** OG001
**Title:** Current Best Practice
#### Outcome Measure 2
**Description:** The time it takes a patient to reach his/her optimal long-acting insulin dose will be measured for both study arms.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** Participants who reached optimal long-acting insulin dose.
**Reporting Status:** POSTED
**Time Frame:** 12 weeks
**Title:** Time to Reach Optimal Long-acting Insulin Dose
**Type:** SECONDARY
**Unit of Measure:** weeks
##### Group
**Description:** Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.

Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration.
**ID:** OG000
**Title:** Mobile Insulin Titration Intervention
##### Group
**Description:** Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
**ID:** OG001
**Title:** Current Best Practice
#### Outcome Measure 3
**Description:** Change in hemoglobin A1c
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** All participants with hemoglobin A1c measurements recorded at baseline and 12 weeks.
**Reporting Status:** POSTED
**Time Frame:** baseline, 12 weeks (approximately 3 months)
**Title:** Hemoglobin A1c
**Type:** SECONDARY
**Unit of Measure:** mg/dL
##### Group
**Description:** Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.

Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration.
**ID:** OG000
**Title:** Mobile Insulin Titration Intervention
##### Group
**Description:** Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
**ID:** OG001
**Title:** Current Best Practice
#### Outcome Measure 4
**Description:** The Diabetes Treatment Satisfaction Questionnaire standard (DTSQs) will be used to measure the patient's satisfaction with diabetes treatment received prior to study participation. Scores on questionnaire range from 0 to 6: 0 = very dissatisfied, 6 = very satisfied.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** All participants who completed the treatment satisfaction questionnaire at baseline.
**Reporting Status:** POSTED
**Time Frame:** baseline
**Title:** Baseline Treatment Satisfaction
**Type:** SECONDARY
**Unit of Measure:** score on satisfaction scale
##### Group
**Description:** Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.

Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration.
**ID:** OG000
**Title:** Mobile Insulin Titration Intervention
##### Group
**Description:** Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
**ID:** OG001
**Title:** Current Best Practice
#### Outcome Measure 5
**Description:** The Diabetes Treatment Satisfaction Questionnaire standard (DTSQs) will be used to measure the patient's satisfaction with diabetes treatment received since initiation of long-acting insulin titration. Scores on questionnaire range from 0 to 6: 0 = very dissatisfied, 6 = very satisfied.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** All participants who completed the treatment satisfaction questionnaire at 12 weeks.
**Reporting Status:** POSTED
**Time Frame:** 12 weeks (approximately 3 months)
**Title:** Treatment Satisfaction After Initiation of Insulin Titration
**Type:** SECONDARY
**Unit of Measure:** score on satisfaction scale
##### Group
**Description:** Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.

Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration.
**ID:** OG000
**Title:** Mobile Insulin Titration Intervention
##### Group
**Description:** Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
**ID:** OG001
**Title:** Current Best Practice
#### Outcome Measure 6
**Description:** The Diabetes Treatment Satisfaction Questionnaire change (DTSQc) will be used to measure the change in the patient's satisfaction with his/her diabetes treatment since initiation of long-acting insulin titration. Scores on questionnaire range from -3 to +3: -3 = much less satisfied now, +3 = much more satisfied now.
**Dispersion Type:** Standard Deviation
**Parameter Type:** MEAN
**Population Description:** All participants who completed the treatment satisfaction questionnaire at 12 weeks.
**Reporting Status:** POSTED
**Time Frame:** 12 weeks (approximately 3 months)
**Title:** Change in Treatment Satisfaction
**Type:** SECONDARY
**Unit of Measure:** score on satisfaction scale
##### Group
**Description:** Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.

Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration.
**ID:** OG000
**Title:** Mobile Insulin Titration Intervention
##### Group
**Description:** Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
**ID:** OG001
**Title:** Current Best Practice
#### Outcome Measure 7
**Description:** The number of instances of hypoglycemia as indicated by fasting blood glucose levels or symptoms reported by patients in both study arms.
**Parameter Type:** NUMBER
**Population Description:** This outcome was analyzed for participants who completed the allocated intervention (and the participant who discontinued insulin early due to a mild possible allergy). Five participants reported hypoglycemia: 3 in the MITI arm and 2 in the CBP arm. All cases were mild.
**Reporting Status:** POSTED
**Time Frame:** 12 weeks
**Title:** Incidence of Hypoglycemia
**Type:** SECONDARY
**Unit of Measure:** instances of hypoglycemia
##### Group
**Description:** Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.

Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration.
**ID:** OG000
**Title:** Mobile Insulin Titration Intervention
##### Group
**Description:** Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
**ID:** OG001
**Title:** Current Best Practice
#### Outcome Measure 8
**Description:** The number of text message replies from participants compared to the total number of text messages sent to participants (asking for blood glucose values). This outcome is given as a percent.
**Parameter Type:** NUMBER
**Population Description:** Participants who completed the allocated intervention.
**Reporting Status:** POSTED
**Time Frame:** 12 weeks
**Title:** Percentage of Text Message Responses
**Type:** OTHER_PRE_SPECIFIED
**Type Units Analyzed:** text messages sent to participants
**Unit of Measure:** percentage of text messages
##### Group
**Description:** Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.

Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration.
**ID:** OG000
**Title:** Mobile Insulin Titration Intervention
#### Outcome Measure 9
**Description:** The number of successful insulin titration phone calls compared to the total number of insulin titration phone calls assigned to the nurse. Successful phone calls are defined as when the nurse was able to reach the participant with one call attempt, two call attempts, or by voicemail. This outcome is given as a percent.
**Parameter Type:** NUMBER
**Population Description:** Participants who completed the allocated intervention.
**Reporting Status:** POSTED
**Time Frame:** 12 weeks
**Title:** Percentage of Successful Phone Calls
**Type:** OTHER_PRE_SPECIFIED
**Type Units Analyzed:** titration phone calls assigned to nurse
**Unit of Measure:** percentage of phone calls
##### Group
**Description:** Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.

Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration.
**ID:** OG000
**Title:** Mobile Insulin Titration Intervention
#### Outcome Measure 10
**Description:** The number of medication refill, emergency department, and walk-in clinic visits at Bellevue Hospital (non-insulin titration visits).
**Parameter Type:** NUMBER
**Population Description:** All participants.
**Reporting Status:** POSTED
**Time Frame:** 12 weeks
**Title:** Patient Healthcare Utilization
**Type:** OTHER_PRE_SPECIFIED
**Unit of Measure:** hospital visits
##### Group
**Description:** Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.

Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration.
**ID:** OG000
**Title:** Mobile Insulin Titration Intervention
##### Group
**Description:** Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
**ID:** OG001
**Title:** Current Best Practice
#### Outcome Measure 11
**Description:** Provider time spent on insulin titration visits by phone compared to insulin titration visits in the clinic.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** Insulin titration visits with a duration recorded.
**Reporting Status:** POSTED
**Time Frame:** 12 weeks
**Title:** Costs - Provider Time Spent on Insulin Titration Visits
**Type:** OTHER_PRE_SPECIFIED
**Type Units Analyzed:** type of insulin titration visit
**Unit of Measure:** minutes
##### Group
**Description:** Insulin titration visits that occurred over the phone in both study arms (MITI and CBP arms).
**ID:** OG000
**Title:** Insulin Titration Visits by Phone
##### Group
**Description:** Insulin titration visits that occurred in the clinic in both study arms (MITI and CBP arms).
**ID:** OG001
**Title:** Insulin Titration Visits in the Clinic
#### Outcome Measure 12
**Description:** The number of insulin titration visits (whether by phone or in the clinic).
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Population Description:** Participants who completed the allocated intervention (and the participant who discontinued insulin early).
**Reporting Status:** POSTED
**Time Frame:** 12 weeks
**Title:** Costs - Titration Visit Information
**Type:** OTHER_PRE_SPECIFIED
**Unit of Measure:** insulin titration visits
##### Group
**Description:** Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.

Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration.
**ID:** OG000
**Title:** Mobile Insulin Titration Intervention
##### Group
**Description:** Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
**ID:** OG001
**Title:** Current Best Practice
#### Outcome Measure 13
**Description:** The time it took patients to travel to Bellevue Hospital, reported by patients in both study arms at baseline and at any subsequent clinic visits.
**Dispersion Type:** Inter-Quartile Range
**Parameter Type:** MEDIAN
**Reporting Status:** POSTED
**Time Frame:** 12 weeks
**Title:** Costs - Patient Travel Time
**Type:** OTHER_PRE_SPECIFIED
**Unit of Measure:** minutes
##### Group
**Description:** Participants in both study arms (MITI and CBP).
**ID:** OG000
**Title:** All Participants
#### Outcome Measure 14
**Description:** At baseline, participants in both study arms (MITI and CBP) reported whether they had to pay co-pays for clinic visits at Bellevue Hospital.
**Parameter Type:** NUMBER
**Reporting Status:** POSTED
**Time Frame:** baseline
**Title:** Costs - Co-pays
**Type:** OTHER_PRE_SPECIFIED
**Unit of Measure:** participants
##### Group
**Description:** Participants in both study arms (MITI and CBP).
**ID:** OG000
**Title:** All Participants
#### Outcome Measure 15
**Description:** The study staff will interview MITI arm patients, using free-response questions, to assess their satisfaction with the intervention. The interviews will take place in person or over the phone at the patient's convenience, after the patient has reached his/her optimal insulin dose. If the patient does not reach optimal insulin dose, the interview will take place at approximately 12 weeks.
**Reporting Status:** NOT_POSTED
**Time Frame:** After patient reaches optimal insulin dose or at 12 weeks
**Title:** Qualitative Patient Satisfaction Interview
**Type:** OTHER_PRE_SPECIFIED
### Participant Flow Module
#### Group
**Description:** Mobile Insulin Titration Intervention (MITI) arm patients will relay their fasting blood glucose levels to the study staff via text message. The patient will receive insulin titration instructions through a weekly phone call with a diabetes nurse.

Mobile Insulin Titration Intervention: Patients send their fasting blood glucose levels to the clinic diabetes nurses via text message each weekday. The diabetes nurses call each patient once a week to give insulin titration instructions to replace in-person clinic visits for insulin titration.
**ID:** FG000
**Title:** Mobile Insulin Titration Intervention
#### Group
**Description:** Current Best Practice (CBP) arm patients will be treated according to the current best practice of insulin titration. They will attend scheduled clinic visits during which the provider will review their blood glucose logs and provide insulin titration instructions.
**ID:** FG001
**Title:** Current Best Practice
#### Period
**Title:** Overall Study
##### Withdraw
**Type:** Phone incompatible with texting platform
###### Reason
**Group ID:** FG000
**Number of Subjects:** 3
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** Did not enroll in texting platform
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** Did not initiate insulin treatment
###### Reason
**Group ID:** FG000
**Number of Subjects:** 1
###### Reason
**Group ID:** FG001
**Number of Subjects:** 0
##### Withdraw
**Type:** Phenotypic type 1 diabetes
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Withdraw
**Type:** Discontinued insulin - possible allergy
###### Reason
**Group ID:** FG000
**Number of Subjects:** 0
###### Reason
**Group ID:** FG001
**Number of Subjects:** 1
##### Milestone
**Type:** STARTED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 33
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 28
##### Milestone
**Type:** COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 28
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 26
##### Milestone
**Type:** NOT COMPLETED
###### Achievement
**Group ID:** FG000
**Number of Subjects:** 5
###### Achievement
**Group ID:** FG001
**Number of Subjects:** 2
**Has Results:** True