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

Diabetes Mellitus, Type 1 Clinical Trial

— PENELOPE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06414824
• Other study ID #: PENELOPE
• Status: Recruiting
• Phase: N/A
• Start date: May 1, 2022
• Est. completion date: December 2024

Study information

• Verified date: May 2024
• Source: Jagiellonian University
• Contact: Jerzy Hohendorff, MD, PhD
• Phone: +48124002950
• Email: jerzy.hohendorff[@]uj.edu.pl
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Hypoglycemia

Intervention

Device:
• Intermittently Scanned Continuous Glucose Monitoring
FreeStyle Libre, 4 weeks
• Standard Blood Glucose Monitoring
Standard blood glucose monitoring with glucose meters

Locations

Country	Name	City	State
Poland	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

Sponsors (2)

Lead Sponsor	Collaborator
Jagiellonian University	Diabetes Poland

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hypoglycemia Fear Survey II	Change in HFS II score from baseline to day 28	Baseline and day 28
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	DKA	Difference in number of hospitalizations for diabetic ketoacidosis between intervention and control group	Baseline to day 28
Secondary	Severe hypoglycemia	Difference in number of severe hypoglycemia episodes between intervention and control group	Baseline to day 28
Secondary	DDS	Change in DDS score from baseline to day 28	Baseline and day 28
Secondary	DTSQ	Change in DTSQ score from baseline to day 28	Baseline and day 28
Secondary	HFS II - Worry subscale	Change in HFS II - worry subscale from baseline to day 28	Baseline and day 28
Secondary	HFS II - Behaviour subscale	Change in HFS II - behaviour subscale from baseline to day 28	Baseline and day 28