The isCGM Use and Hypoglycemic Episodes and Fear of Hypoglycemia in Newly Diagnosed Type 1 Diabetes (PENELOPE)

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

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).

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 1
• Intervention / Treatment: Device: Intermittently Scanned Continuous Glucose Monitoring; Device: Standard Blood Glucose Monitoring

• Study Type: Interventional
• Enrollment (Estimated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jerzy Hohendorff, MD, PhD; Phone Number: +48124002950; Email: jerzy.hohendorff@uj.edu.pl

Study Locations

• Poland
  • Bialystok, Poland
    • Recruiting
    • Department of Endocrinology, Diabetology and Internal Medicine, Medical University of Bialystok
  • Krakow, Poland
    • Recruiting
    • Department of Metabolic Diseases, Jagiellonian University Medical College
  • Poznan, Poland
    • Recruiting
    • Department of Internal Medicine and Diabetology, Poznan University of Medical Sciences
  • Zabrze, Poland
    • Recruiting
    • Department of Internal Medicine, Diabetology, and Cardiometabolic Disorders, Medical University of Silesia in Katowice

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: FreeStyle Libre; FreeStyle Libre for 4 weeks. All subjects will wear a masked sensor (FreeStyle Libre Pro) for 14 days prior to randomisation.	Device: Intermittently Scanned Continuous Glucose Monitoring; FreeStyle Libre, 4 weeks; Other Names: FreeStyle Libre
Active Comparator: SMBG; 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.	Device: Standard Blood Glucose Monitoring; Standard blood glucose monitoring with glucose meters

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hypoglycemia Fear Survey II	Change in HFS II score from baseline to day 28	Baseline and day 28
TBR <70 mg/dL	Difference in time <70 mg/dL between intervention and control group assessed in days 14 to 28	Baseline and days 14 to 28

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TIR	Difference in TIR 70-180 mg/dL between intervention and control group assessed in days 14 to 28	Baseline and days 14 to 28
TBR <54 mg/dL	Difference in TBR <54 mg/dL between intervention and control group assessed in days 14 to 28	Baseline and days 14 to 28
TAR >180 mg/dl	Difference in TAR >180 mg/dL between intervention and control group assessed in days 14 to 28	Baseline and days 14 to 28
TAR >250 mg/dl	Difference in TAR >250 mg/dL between intervention and control group assessed in days 14 to 28	Baseline and days 14 to 28
DKA	Difference in number of hospitalizations for diabetic ketoacidosis between intervention and control group	Baseline to day 28
Severe hypoglycemia	Difference in number of severe hypoglycemia episodes between intervention and control group	Baseline to day 28
DDS	Change in DDS score from baseline to day 28	Baseline and day 28
DTSQ	Change in DTSQ score from baseline to day 28	Baseline and day 28
HFS II - Worry subscale	Change in HFS II - worry subscale from baseline to day 28	Baseline and day 28
HFS II - Behaviour subscale	Change in HFS II - behaviour subscale from baseline to day 28	Baseline and day 28

Collaborators and Investigators

• Sponsor: Jagiellonian University
• Collaborators: Diabetes Poland

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: May 10, 2024
• First Submitted That Met QC Criteria: May 10, 2024
• First Posted (Actual): May 16, 2024

Study Record Updates

• Last Update Posted (Actual): May 16, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Keywords: continuous glucose monitoring; time in range; fear of hypoglycemia; ambulatory glucose profile
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia
• Other Study ID Numbers: PENELOPE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No