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

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

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).

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.