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

Jagiellonian University

Status: Terminated

Conditions: Diabetes Mellitus, Type 1

Treatments: Device: Intermittently Scanned Continuous Glucose Monitoring; Device: Standard Blood Glucose Monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT06414824

PENELOPE

Details and patient eligibility

About

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).

Enrollment: 28 patients

Sex: All

Ages: 18 to 35 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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28 participants in 2 patient groups

FreeStyle Libre

Experimental group

Description:

FreeStyle Libre for 4 weeks. All subjects will wear a masked sensor (FreeStyle Libre Pro) for 14 days prior to randomisation.

Treatment:

Device: Intermittently Scanned Continuous Glucose Monitoring

SMBG

Active Comparator group

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.

Treatment:

Device: Standard Blood Glucose Monitoring