## Protocol Section
### Identification Module
**NCT ID:** NCT06414824

**Acronym:** PENELOPE

**Brief Title:** The isCGM Use and Hypoglycemic Episodes and Fear of Hypoglycemia in Newly Diagnosed Type 1 Diabetes

**Official Title:** The Impact of the isCGM Use on the Hypoglycemic Episodes and Fear of Hypoglycemia in Patients With Newly Diagnosed Type 1 Diabetes

#### Organization Study ID Info
**ID:** PENELOPE
#### Organization
**Class:** OTHER
**Full Name:** Jagiellonian University
### Status Module
#### Completion Date
**Date:** 2024-12

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-16

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-10

**Overall Status:** RECRUITING

#### Primary Completion Date
**Date:** 2024-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2022-05-01

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-16
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-10
**Study First Submit QC Date:** 2024-05-10
### Sponsor Collaborators Module

#### Collaborators

**Class:** UNKNOWN

**Name:** Diabetes Poland

#### Lead Sponsor

**Class:** OTHER

**Name:** Jagiellonian University

#### Responsible Party

**Investigator Affiliation:** Jagiellonian University

**Investigator Full Name:** Jerzy Hohendorff

**Investigator Title:** MD, PhD

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Is US Export:** False

### Description Module

**Brief Summary:** The aim of this trial is to investigate the impact of FreeStyle Libre use compared to SMBG on hypoglycemia episodes and fear of hypoglycemia in adults aged 18-35 with newly diagnosed type 1 diabetes.

This trial is conducted in university centers in Poland (Bialystok, Krakow, Poznan, Zabrze).

### Conditions Module

**Conditions:**

- Diabetes Mellitus, Type 1

**Keywords:**

- ambulatory glucose profile

- time in range

- fear of hypoglycemia

- continuous glucose monitoring

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** NONE

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 100

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** FreeStyle Libre for 4 weeks.

All subjects will wear a masked sensor (FreeStyle Libre Pro) for 14 days prior to randomisation.

**Intervention Names:**

- Device: Intermittently Scanned Continuous Glucose Monitoring

**Label:** FreeStyle Libre

**Type:** EXPERIMENTAL

#### Arm Group 2

**Description:** Subjects randomised to the control group will monitor their blood glucose with standard blood glucose meters.

A 14-day FreeStyle Libre Pro is included for these subjects from day 14 to day 28 to collect glycaemic data for comparison to the intervention group of the study.

All subjects will wear a masked sensor (FreeStyle Libre Pro) for 14 days prior to randomisation.

**Intervention Names:**

- Device: Standard Blood Glucose Monitoring

**Label:** SMBG

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- FreeStyle Libre

**Description:** FreeStyle Libre, 4 weeks

**Name:** Intermittently Scanned Continuous Glucose Monitoring

**Other Names:**

- FreeStyle Libre

**Type:** DEVICE

#### Intervention 2

**Arm Group Labels:**

- SMBG

**Description:** Standard blood glucose monitoring with glucose meters

**Name:** Standard Blood Glucose Monitoring

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Change in HFS II score from baseline to day 28

**Measure:** Hypoglycemia Fear Survey II

**Time Frame:** Baseline and day 28

**Description:** Difference in time \<70 mg/dL between intervention and control group assessed in days 14 to 28

**Measure:** TBR <70 mg/dL

**Time Frame:** Baseline and days 14 to 28

#### Secondary Outcomes

**Description:** Difference in TIR 70-180 mg/dL between intervention and control group assessed in days 14 to 28

**Measure:** TIR

**Time Frame:** Baseline and days 14 to 28

**Description:** Difference in TBR \<54 mg/dL between intervention and control group assessed in days 14 to 28

**Measure:** TBR <54 mg/dL

**Time Frame:** Baseline and days 14 to 28

**Description:** Difference in TAR \>180 mg/dL between intervention and control group assessed in days 14 to 28

**Measure:** TAR >180 mg/dl

**Time Frame:** Baseline and days 14 to 28

**Description:** Difference in TAR \>250 mg/dL between intervention and control group assessed in days 14 to 28

**Measure:** TAR >250 mg/dl

**Time Frame:** Baseline and days 14 to 28

**Description:** Difference in number of hospitalizations for diabetic ketoacidosis between intervention and control group

**Measure:** DKA

**Time Frame:** Baseline to day 28

**Description:** Difference in number of severe hypoglycemia episodes between intervention and control group

**Measure:** Severe hypoglycemia

**Time Frame:** Baseline to day 28

**Description:** Change in DDS score from baseline to day 28

**Measure:** DDS

**Time Frame:** Baseline and day 28

**Description:** Change in DTSQ score from baseline to day 28

**Measure:** DTSQ

**Time Frame:** Baseline and day 28

**Description:** Change in HFS II - worry subscale from baseline to day 28

**Measure:** HFS II - Worry subscale

**Time Frame:** Baseline and day 28

**Description:** Change in HFS II - behaviour subscale from baseline to day 28

**Measure:** HFS II - Behaviour subscale

**Time Frame:** Baseline and day 28

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Newly diagnosed type 1 diabetes (diagnosed based on the WHO criteria) no later than 6 months after the diagnosis.
* Insulin therapy: multiple daily injections,
* In the investigator's opinion, the participant must be technically capable of using the FreeStyle Libre system

Exclusion Criteria:

* Current or past use of any continuous glucose monitoring system.
* Pump therapy.
* Known allergy to medical adhesives.
* Oral steroid therapy.
* Pregnancy or planning pregnancy within the study duration.
* Breast feeding.
* Dialysis treatment.
* Having a pacemaker.
* Unstable coronary heart disease.
* Cystic fibrosis.
* Cancer.
* Psychiatric disorders.
* Severe end-organ damage (kidney, liver, etc) or any uncontrolled disorder.
* Hospitalization for any reason other than the newly diagnosed type 1 diabetes 6 months prior to inclusion.
* Participating in another clinical trial that could affect glucose measurements or glucose management.
* In the investigator's opinion, if the participant is considered unsuitable for inclusion in the study for any other reason.

**Maximum Age:** 35 Years

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** jerzy.hohendorff@uj.edu.pl

**Name:** Jerzy Hohendorff, MD, PhD

**Phone:** +48124002950

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Bialystok

**Country:** Poland

**Facility:** Department of Endocrinology, Diabetology and Internal Medicine, Medical University of Bialystok

**Status:** RECRUITING

**Location 2:**

**City:** Krakow

**Country:** Poland

**Facility:** Department of Metabolic Diseases, Jagiellonian University Medical College

**Status:** RECRUITING

**Location 3:**

**City:** Poznan

**Country:** Poland

**Facility:** Department of Internal Medicine and Diabetology, Poznan University of Medical Sciences

**Status:** RECRUITING

**Location 4:**

**City:** Zabrze

**Country:** Poland

**Facility:** Department of Internal Medicine, Diabetology, and Cardiometabolic Disorders, Medical University of Silesia in Katowice

**Status:** RECRUITING

### IPD Sharing Statement Module

**IPD Sharing:** NO

## Derived Section

### Condition Browse Module - Ancestors

- 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: HIGH

- As Found: Diabetes

- ID: M7117

- Name: Diabetes Mellitus, Type 1

- Relevance: HIGH

- As Found: Diabetes Mellitus, Type 1

- ID: M10053

- Name: Hypoglycemia

- Relevance: HIGH

- As Found: Hypoglycemia

- 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: D000003920

- Term: Diabetes Mellitus

- ID: D000003922

- Term: Diabetes Mellitus, Type 1

- ID: D000007003

- Term: Hypoglycemia

### Intervention Browse Module - Browse Branches

- Abbrev: Hypo

- Name: Hypoglycemic Agents

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M10054

- Name: Hypoglycemic Agents

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-31
