Glycemic Excursions in Patients With Type 1 Diabetes Mellitus Using Closed-loop Systems

NCT06382350 | Recruiting FDA Device

• 1 other identifier: KHL-002-2024
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to compare glycemic excursions during several life situations (such as periods of driving, periods of night sleep, periods of occupation, periods of physical activity, and periods of stress) in patients with type 1 diabetes treated with closed-loop system and multiple daily insulin dose therapy

Conditions

Type 1 Diabetes Mellitus; Type 1 Diabetes Mellitus With Hypoglycemia; Drive

Keywords

Type 1 diabetes mellitus; Driving; Closed-loop system

Outcome Measures

Primary Outcomes (1)

• The frequency of hypoglycemia during the driving periods

  This outcome evaluates the number of hypoglycemic events (drop of glycemia \<3.9 mmol/l) during the driving periods.

  10 days of CGM measurement

Secondary Outcomes (1)

• Amount of time spent in the glycemic range between 3.9 and 4.5 mmol/l during the driving periods.

  10 days of CGM measurement

Other Outcomes (8)

• Analysis of glycemia

  10 days of CGM measurement

• Number of alarms generated by the insulin pump

  10 days of CGM measurement

• Insulin dosing

  10 days of CGM measurement

Study Arms (2)

Study group

Type 1 diabetes patients with insulin pump MiniMed 780 G +CGM (continuous glucose monitoring)

Device: MiniMed 780 G

Control group

Type 1 diabetes patients with patients treated by multiple daily injections (MDI) + CGM

Interventions

MiniMed 780 G DEVICE

none, observational study

Study group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Type 1 diabetes patients

You may qualify if:

• Study group:
• type 1 diabetes
• patients aged ≥18 year
• diabetes duration ≥3 years
• regularly driving (non-professional drivers only)
• treated with insulin pump MiniMed 780 G for at least 6 months with closed-loop setting treatment
• willing to fill in the study questionnaires
• signed patient's informed consent form
• Control group:
• type 1 diabetes
• patients aged ≥18 years
• diabetes duration ≥3 years
• regularly driving (non-professional drivers only)
• treatment with multiple daily injections (MDI) of insulin therapy and the use of CGM for at least 6 months
• willing to fill in the study questionnaires

You may not qualify if:

• professional drivers
• pregnancy
• inability to be present at the follow-up visit
• inability to complete the study questionnaires
• participation in another clinical study within the last 3 months

Sponsors & Collaborators

• University Hospital, Motol: lead

Study Sites (1)

UH Motol

Prague, 150 00, Czechia

RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Jan Brož, MUDr., Ph.D.

  Second Medical Faculty, Charles University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Eva Al Jamal, Mgr.

CONTACT

224 431 017; eva.aljamal@fnmotol.cz

Veronika Šourková

CONTACT

224 431 004; veronika.sourkova@fnmotol.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 19, 2024
• First Posted: April 24, 2024
• Study Start: May 29, 2024
• Primary Completion: September 1, 2025
• Study Completion: May 1, 2026
• Last Updated: June 4, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (1)