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

NCT06414824 | Terminated

• 1 other identifier: PENELOPE
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 4

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

Diabetes Mellitus, Type 1

Keywords

ambulatory glucose profile; time in range; fear of hypoglycemia; continuous glucose monitoring

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (10)

• TIR

  Baseline and days 14 to 28

• TBR <54 mg/dL

  Baseline and days 14 to 28

• TAR >180 mg/dl

  Baseline and days 14 to 28

• TAR >250 mg/dl

  Baseline and days 14 to 28

• DKA

  Baseline to day 28

Study Arms (2)

FreeStyle Libre

EXPERIMENTAL

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

SMBG

ACTIVE COMPARATOR

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

Interventions

Intermittently Scanned Continuous Glucose Monitoring DEVICE

FreeStyle Libre, 4 weeks

Also known as: FreeStyle Libre

FreeStyle Libre

Standard Blood Glucose Monitoring DEVICE

Standard blood glucose monitoring with glucose meters

SMBG

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.
• Participating in another clinical trial that could affect glucose measurements or glucose management.

Sponsors & Collaborators

• Jagiellonian University: lead
• Diabetes Poland: collaborator

Study Sites (4)

Department of Endocrinology, Diabetology and Internal Medicine, Medical University of Bialystok

Bialystok, Poland

Location

Department of Metabolic Diseases, Jagiellonian University Medical College

Krakow, Poland

Location

Department of Internal Medicine and Diabetology, Poznan University of Medical Sciences

Poznan, Poland

Location

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

Zabrze, Poland

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: May 10, 2024
• First Posted: May 16, 2024
• Study Start: May 1, 2022
• Primary Completion: December 31, 2023
• Study Completion: May 31, 2024
• Last Updated: October 2, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will not share

Locations

PL (4)