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

Not Applicable

Recruiting

• Conditions: Type1diabetes
• Interventions: Device: Universal meal coefficient utilization

• Registration Number: NCT06372392
• Lead Sponsor: Tartu University Hospital

Brief 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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2023-10-10
• Status Verified: 2024-04
• Study First Submitted: 2024-04-10
• Study First Submitted QC: 2024-04-13
• Last Update Submitted: 2024-04-13
• Study First Posted: 2024-04-18
• Last Update Posted: 2024-04-18
• Primary Completion: 2024-06-10
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 20

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.

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Exclusion Criteria

• Active coeliac disease
• Chronic disease possible to influence diabetes treatment
• Acute disease at the moment of recruitment

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Universal coefficient	Universal meal coefficient utilization	With fixed meal bolus coefficients (TDD/300 breakfast and TDD/400 other meals)
Individualized coefficient	Universal meal coefficient utilization	With meal bolus coefficient individualized according to physician judgment's

Primary Outcome Measures

Name	Time	Method
Time in range (TIR)	4 weeks	Comparision of TIR between groups

Secondary Outcome Measures

Name	Time	Method
TBR	4 weeks	Comparision of TBR between groups
auto-corrections %	4 weeks	auto-corrections % between groups
coefficient of variability	4 weeks	coefficient of variability between groups
TAR	4 weeks	Comparision of TAR between groups

Trial Locations

Locations (1)

TartuUH; 🇪🇪 Tartu, Tartumaa, Estonia