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

Not Applicable

Terminated

• Conditions: Diabetes Mellitus, Type 1
• Interventions: Device: Intermittently Scanned Continuous Glucose Monitoring; Device: Standard Blood Glucose Monitoring

• Registration Number: NCT06414824
• Lead Sponsor: Jagiellonian University

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2022-05-01
• Primary Completion: 2023-12-31
• Study First Submitted: 2024-05-10
• Study First Submitted QC: 2024-05-10
• Study First Posted: 2024-05-16
• Study Completion: 2024-05-31
• Status Verified: 2024-09
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 28

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
FreeStyle Libre	Intermittently Scanned Continuous Glucose Monitoring	FreeStyle Libre for 4 weeks. All subjects will wear a masked sensor (FreeStyle Libre Pro) for 14 days prior to randomisation.
SMBG	Standard Blood Glucose Monitoring	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.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Department of Endocrinology, Diabetology and Internal Medicine, Medical University of Bialystok; 🇵🇱 Bialystok, Poland

Department of Metabolic Diseases, Jagiellonian University Medical College; 🇵🇱 Krakow, Poland

Department of Internal Medicine and Diabetology, Poznan University of Medical Sciences; 🇵🇱 Poznan, Poland

Department of Internal Medicine, Diabetology, and Cardiometabolic Disorders, Medical University of Silesia in Katowice; 🇵🇱 Zabrze, Poland