## Protocol Section
### Identification Module
**NCT ID:** NCT06428591

**Brief Title:** Tandem Freedom - Feasibility Trial 1

**Official Title:** Tandem Freedom - Feasibility Trial 1

#### Organization Study ID Info
**ID:** TP-0017517
#### Organization
**Class:** INDUSTRY
**Full Name:** Tandem Diabetes Care, Inc.
#### Secondary ID Infos
**Domain:** ICTRP
**ID:** U1111-1307-6267
**Type:** OTHER
### Status Module
#### Completion Date
**Date:** 2024-06-10

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-31

**Type:** ESTIMATED

**Last Update Submit Date:** 2024-05-29

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-06-10

**Type:** ESTIMATED

#### Start Date
**Date:** 2024-05-29

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-24
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-20
**Study First Submit QC Date:** 2024-05-20
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Tandem Diabetes Care, Inc.

#### Responsible Party

**Type:** SPONSOR

### Oversight Module

**Is FDA Regulated Device:** True

**Is FDA Regulated Drug:** False

**Is Unapproved Device:** True

**Is US Export:** True

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** This feasibility study is a prospective, single arm study evaluating the Tandem Freedom system in adults with type 1 diabetes. Existing Control-IQ technology users will use Control-IQ technology at home for a 1 week run-in, then will use Tandem Freedom in a supervised hotel setting for 3 days/nights.

**Detailed Description:** After a 1 week Control-IQ run-in at home, 10 adults who are existing Control-IQ users with type 1 diabetes will use the Tandem Freedom System for 3 days/nights in a supervised hotel setting. Participants will perform meal and exercise challenges. The primary outcome is safety events. CGM time in ranges will also be evaluated.

### Conditions Module

**Conditions:**

- Diabetes Mellitus, Type 1

**Keywords:**

- type 1 diabetes

- T1D

- Tandem

- t:slim X2

- automated insulin delivery

### Design Module

#### Design Info

**Allocation:** NA

**Intervention Model:** SINGLE_GROUP

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 10

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** After a 1 week Control-IQ run-in, adults with type 1 diabetes will complete a supervised hotel study with the Tandem Freedom system for 3 days/nights.

**Intervention Names:**

- Device: t:slim X2 insulin pump with Tandem Freedom Algorithm

**Label:** Tandem Freedom

**Type:** EXPERIMENTAL

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Tandem Freedom

**Description:** Participants will use the Tandem Freedom system for 3 day/nights in a supervised hotel setting, performing meal and exercise challenges.

**Name:** t:slim X2 insulin pump with Tandem Freedom Algorithm

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment)

**Measure:** Severe Hypoglycemia events

**Time Frame:** 3 days

**Description:** Number of diabetic ketoacidosis events

**Measure:** Diabetic Ketoacidosis events

**Time Frame:** 3 days

**Description:** Number of unanticipated adverse device effects

**Measure:** Unanticipated adverse device effects

**Time Frame:** 3 days

**Description:** Number of other serious device-related adverse events

**Measure:** Other serious device-related adverse events

**Time Frame:** 3 days

#### Secondary Outcomes

**Description:** CGM measured percent time \<70 mg/dL, overall

**Measure:** Percent Time <70 mg/dL, overall

**Time Frame:** 3 days

**Description:** CGM measured percent time \<70 mg/dL, during the daytime

**Measure:** Percent Time <70 mg/dL, daytime

**Time Frame:** 3 days

**Description:** CGM measured percent time \<70 mg/dL, during the nighttime

**Measure:** Percent Time <70 mg/dL, nighttime

**Time Frame:** 3 days

**Description:** CGM measured percent time \<54 mg/dL, overall

**Measure:** Percent Time <54 mg/dL, overall

**Time Frame:** 3 days

**Description:** CGM measured percent time \<54 mg/dL, during the daytime

**Measure:** Percent Time <54 mg/dL, daytime

**Time Frame:** 3 days

**Description:** CGM measured percent time \<54 mg/dL, during the nighttime

**Measure:** Percent Time <54 mg/dL, nighttime

**Time Frame:** 3 days

**Description:** CGM measured percent time in range 70 - 180 mg/dL, overall

**Measure:** Percent Time in Range 70 - 180 mg/dL, overall

**Time Frame:** 3 days

**Description:** CGM measured percent time in range 70 - 180 mg/dL, daytime

**Measure:** Percent Time in Range 70 - 180 mg/dL, daytime

**Time Frame:** 3 days

**Description:** CGM measured percent time in range 70 - 180 mg/dL, nighttime

**Measure:** Percent Time in Range 70 - 180 mg/dL, nighttime

**Time Frame:** 3 days

**Description:** CGM measured percent time in range 70 - 140 mg/dL, overall

**Measure:** Percent Time in Range 70 - 140 mg/dL, overall

**Time Frame:** 3 days

**Description:** CGM measured percent time in range 70 - 140 mg/dL, daytime

**Measure:** Percent Time in Range 70 - 140 mg/dL, daytime

**Time Frame:** 3 days

**Description:** CGM measured percent time in range 70 - 140 mg/dL, nighttime

**Measure:** Nighttime Percent between 70-140 mg/dL, nighttime

**Time Frame:** 3 days

**Description:** CGM measured percent time \>180 mg/dL, overall

**Measure:** Percent Time >180 mg/dL, overall

**Time Frame:** 3 days

**Description:** CGM measured percent time \>180 mg/dL, daytime

**Measure:** Percent Time >180 mg/dL, daytime

**Time Frame:** 3 days

**Description:** CGM measured percent time \>180 mg/dL, nighttime

**Measure:** Percent Time >180 mg/dL, nighttime

**Time Frame:** 3 days

**Description:** CGM measured percent time \>250mg/dL, overall

**Measure:** Percent Time >250 mg/dL, overall

**Time Frame:** 3 days

**Description:** CGM measured percent time \>250mg/dL, daytime

**Measure:** Daytime Percent time >250 mg/dL, daytime

**Time Frame:** 3 days

**Description:** CGM measured percent time \>250mg/dL, nighttime

**Measure:** Nighttime Percent time >250 mg/dL, nighttime

**Time Frame:** 3 days

**Description:** CGM measured mean glucose (mg/dL), overall

**Measure:** Mean glucose (mg/dL), overall

**Time Frame:** 3 days

**Description:** CGM measured mean glucose (mg/dL), daytime

**Measure:** Mean glucose (mg/dL), daytime

**Time Frame:** 3 days

**Description:** CGM measured mean glucose (mg/dL), nighttime

**Measure:** Mean glucose (mg/dL), nighttime

**Time Frame:** 3 days

**Description:** CGM measured Coefficient of Variation (%), overall

**Measure:** Glycemic Variability as assessed by Coefficient of Variation (%), overall

**Time Frame:** 3 days

**Description:** CGM measured Coefficient of Variation (%), daytime

**Measure:** Glycemic Variability as assessed by Coefficient of Variation (%), daytime

**Time Frame:** 3 days

**Description:** CGM measured Coefficient of Variation (%), nighttime

**Measure:** Glycemic Variability as assessed by Coefficient of Variation (%), nighttime

**Time Frame:** 3 days

**Description:** CGM measured Standard Deviation (mg/dL), overall

**Measure:** Glycemic Variability as assessed by Standard Deviation (mg/dL), overall

**Time Frame:** 3 days

**Description:** CGM measured Standard Deviation (mg/dL), daytime

**Measure:** Glycemic Variability as assessed by Standard Deviation (mg/dL), daytime

**Time Frame:** 3 days

**Description:** CGM measured Standard Deviation (mg/dL), nighttime

**Measure:** Glycemic Variability as assessed by Standard Deviation (mg/dL), nighttime

**Time Frame:** 3 days

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Age ≥18 years old
* Diagnosis of type 1 diabetes for at least 1 year
* Current Control-IQ user, having been prescribed Control-IQ for at least 3 months
* HbA1c ≤10%, recorded in the last 3 months
* Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol, including performing the weekend hotel observed setting portion of the study.
* Willing to use only aspart (novorapid) or lispro (humalog) insulin with the study pump, with no use of long-acting basal insulin injections, or inhaled insulin with the study pump.
* Have current glucagon product to treat severe hypoglycemia (injectable or nasal) at home (site will provide prescription if they do not have one)

Exclusion Criteria:

* More than 1 episode of diabetic ketoacidosis (DKA) in the past 6 months
* More than 1 episode of severe hypoglycemia (needing assistance) in the past 6 months
* Inpatient psychiatric treatment in the past 6 months
* For Female: Currently pregnant or planning to become pregnant during the time period of study participation

  1. A negative pregnancy test will be required for all females of child-bearing potential
  2. Counseling on appropriate birth control options will be provided to all females of child-bearing potential
* Concurrent use of any non-insulin glucose-lowering agent, other than metformin (for example, GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas).
* Hemophilia or any other bleeding disorder
* Hemoglobinopathy
* History of heart, liver, lung or kidney disease determined by investigator to interfere with the study
* History of allergic reaction to Humalog or Novorapid
* Use of any medications determined by investigator to interfere with study
* Significant chronic kidney disease (which could impact CGM accuracy in investigator's judgment) or hemodialysis
* Concurrent use of any medication that could interfere with the study CGM, such as hydroxyurea
* History of adrenal insufficiency
* History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated
* History of gastroparesis
* A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
* Participation in another pharmaceutical or device trial at the time of enrollment or anticipated for during the time period of study participation
* Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc., or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Christchurch

**Contacts:**

***Contact 1:***

- **Email:** renee.meier@otago.ac.nz

- **Name:** Renee Meier

- **Phone:** 64 3 372 6763

- **Role:** CONTACT

***Contact 2:***

- **Name:** Martin de Bock, FRACP PhD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** New Zealand

**Facility:** University of Otago

**Status:** RECRUITING

**Zip:** 8140

#### Overall Officials

**Official 1:**

**Affiliation:** Tandem Diabetes Care

**Name:** Jordan Pinsker, MD

**Role:** STUDY_DIRECTOR

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000003920

- Term: Diabetes Mellitus

- ID: D000044882

- Term: Glucose Metabolism Disorders

- ID: D000008659

- Term: Metabolic Diseases

- ID: D000004700

- Term: Endocrine System Diseases

- ID: D000001327

- Term: Autoimmune Diseases

- ID: D000007154

- Term: Immune System Diseases

### 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: BC20

- Name: Immune System Diseases

### Condition Browse Module - Browse Leaves

- ID: M7115

- Name: Diabetes Mellitus

- Relevance: LOW

- As Found: Unknown

- ID: M7117

- Name: Diabetes Mellitus, Type 1

- Relevance: HIGH

- As Found: Diabetes Mellitus, Type 1

- ID: M11639

- Name: Metabolic Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M25403

- Name: Glucose Metabolism Disorders

- Relevance: LOW

- As Found: Unknown

- ID: M7862

- Name: Endocrine System Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4629

- Name: Autoimmune Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10200

- Name: Immune System Diseases

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000003922

- Term: Diabetes Mellitus, Type 1

### 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: 2024-05-31
