Clinical trial NCT06414824: The isCGM Use and Hypoglycemic Episodes and Fear of Hypoglycemia in Newly Diagnosed Type 1 Diabetes
Official title: The Impact of the isCGM Use on the Hypoglycemic Episodes and Fear of Hypoglycemia in Patients With Newly Diagnosed Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: ambulatory glucose profile
time in range
fear of hypoglycemia
continuous glucose monitoring
Lead sponsor: Jagiellonian University
Sponsor class: OTHER
Collaborators: name: Diabetes Poland
First posted: 2024-05-16
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Hypoglycemia Fear Survey II
timeFrame: Baseline and day 28
measure: TBR <70 mg/dL
timeFrame: Baseline and days 14 to 28
Secondary outcomes:
measure: TIR
timeFrame: Baseline and days 14 to 28
measure: TBR <54 mg/dL
timeFrame: Baseline and days 14 to 28
measure: TAR >180 mg/dl
timeFrame: Baseline and days 14 to 28
measure: TAR >250 mg/dl
timeFrame: Baseline and days 14 to 28
measure: DKA
timeFrame: Baseline to day 28
measure: Severe hypoglycemia
timeFrame: Baseline to day 28
measure: DDS
timeFrame: Baseline and day 28
measure: DTSQ
timeFrame: Baseline and day 28
measure: HFS II - Worry subscale
timeFrame: Baseline and day 28
measure: HFS II - Behaviour subscale
timeFrame: Baseline and day 28
Other outcomes:
Locations:
city: Bialystok
country: Poland
facility: Department of Endocrinology, Diabetology and Internal Medicine, Medical University of Bialystok
city: Krakow
country: Poland
facility: Department of Metabolic Diseases, Jagiellonian University Medical College
city: Poznan
country: Poland
facility: Department of Internal Medicine and Diabetology, Poznan University of Medical Sciences
city: Zabrze
country: Poland
facility: Department of Internal Medicine, Diabetology, and Cardiometabolic Disorders, Medical University of Silesia in Katowice
Study officials:
References: