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NCT06372392 Clinical Trial

Universal Fixed Meal Boluses Usage in Patients With Medtronic Minimed 780G Pumps

Type1diabetes Clinical Trial

Official title:
Randomized Controlled Study of the Usage of Universal Fixed Meal Bolus Coefficients for the Control of Postprandial Hyperglycemia in the Users of Medtronic Minimed 780G Pumps

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06372392
Other study ID # 1.0
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date October 10, 2023
Est. completion date December 1, 2024

Study information
Verified date April 2024
Source Tartu University Hospital
Contact Aleksandr Peet, MD, PhD
Phone 5532256
Email aleksandr.peet@kliinikum.ee
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Cross-over study of 20 pediatric patients (age 7-19) randomized to the group receiving universal fixed meal boluses coefficients (300/TDD for breakfast and 400/TDD other meal) or to the group with individualized coefficients for the period of 14 days with consecutive analysis of the results from Carelink Raport.

Recruitment information / eligibility
Status Recruiting
Enrollment 20
Est. completion date December 1, 2024
Est. primary completion date June 10, 2024
Accepts healthy volunteers No
Gender All
Age group 7 Years to 19 Years
Eligibility Inclusion Criteria: - age 7-19 - type 1 diabetes diagnosed at least 1 year ago - insulin in the dose 0,5-1,0 units/day/kg - MiniMed 780G pump usage at least 1 month. Exclusion Criteria: - Active coeliac disease - Chronic disease possible to influence diabetes treatment - Acute disease at the moment of recruitment

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Universal meal coefficient utilization
Usage of universal fixed meal bolus coefficients for the control of postprandial hyperglycemia compared to individualized coefficients n the users of Medtronic Minimed 780G pumps

Locations
Country Name City State
Estonia TartuUH Tartu Tartumaa

Sponsors (2)
Lead Sponsor Collaborator
Tartu University Hospital Estonia Research Council

Country where clinical trial is conducted

Estonia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Time in range (TIR) Comparision of TIR between groups 4 weeks
Secondary TBR Comparision of TBR between groups 4 weeks
Secondary TAR Comparision of TAR between groups 4 weeks
Secondary auto-corrections % auto-corrections % between groups 4 weeks
Secondary coefficient of variability coefficient of variability between groups 4 weeks
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