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

Tartu University Hospital

Status: Enrolling

Conditions: Type1diabetes

Treatments: Device: Universal meal coefficient utilization

Study type: Interventional

Funder types: Other

Identifiers

NCT06372392

1.0

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 7 to 19 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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20 participants in 2 patient groups

Universal coefficient

Experimental group

Description:

With fixed meal bolus coefficients (TDD/300 breakfast and TDD/400 other meals)

Treatment:

Device: Universal meal coefficient utilization

Individualized coefficient

Active Comparator group

Description:

With meal bolus coefficient individualized according to physician judgment's

Treatment:

Device: Universal meal coefficient utilization