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

Last updated: September 30, 2024
Sponsor: Jagiellonian University
Overall Status: Terminated

Phase

N/A

Condition

Hormone Deficiencies

Diabetes Prevention

Diabetes Mellitus, Type 1

Treatment

Intermittently Scanned Continuous Glucose Monitoring

Standard Blood Glucose Monitoring

Clinical Study ID

NCT06414824
PENELOPE
  • Ages 18-35
  • All Genders

Study 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

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 usingthe FreeStyle Libre system

Exclusion

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 6months prior to inclusion.

  • Participating in another clinical trial that could affect glucose measurements orglucose management.

  • In the investigator's opinion, if the participant is considered unsuitable forinclusion in the study for any other reason.

Study Design

Total Participants: 28
Treatment Group(s): 2
Primary Treatment: Intermittently Scanned Continuous Glucose Monitoring
Phase:
Study Start date:
May 01, 2022
Estimated Completion Date:
May 31, 2024

Connect with a study center

  • Department of Endocrinology, Diabetology and Internal Medicine, Medical University of Bialystok

    Bialystok,
    Poland

    Site Not Available

  • Department of Metabolic Diseases, Jagiellonian University Medical College

    Krakow,
    Poland

    Site Not Available

  • Department of Internal Medicine and Diabetology, Poznan University of Medical Sciences

    Poznan,
    Poland

    Site Not Available

  • Department of Internal Medicine, Diabetology, and Cardiometabolic Disorders, Medical University of Silesia in Katowice

    Zabrze,
    Poland

    Site Not Available

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