Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes

Tartu University Hospital

Status: Unknown

Conditions: Type 1 Diabetes

Treatments: Device: Dual-bolus; Device: Standard bolus

Study type: Interventional

Funder types: Other

Identifiers

NCT04668612

1.1

Details and patient eligibility

About

To analyze with the aid of CGM the blood sugar profiles of children receiving dual-wave versus standard bolus for dinner.

Full description

Primary objective To analyze with the aid of CGM the blood sugar profiles of children receiving dual-wave versus standard bolus for dinner.

Primary endpoint To compare time in range (TIR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner.

Trial design This is a 28-day long prospective randomized open-label single-center crossover clinical study with a 14-day long run-in phase.

Trial population A total of 30 subjects with type 1 diabetes.

Enrollment: 30 estimated patients

Sex: All

Ages: 7 to 18 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Children aged 7-18 years treated at the Children's Clinic of Tartu University Hospital for type1 diabetes.
2. Insulin pump and CGM initiated at least 3 months prior to the recruitment.
3. Estimated HbA1c based on the 14-days CGM report above 8.5%.
4. Daily insulin dose of more than 0.5 international units per kilogram.

Exclusion criteria

1. Subjects with known diabetes complications.
2. Elevated tissue transglutaminase IgA antibodies in the last two years.
3. Children who developed an acute viral infections during the week preceding the recruitment.

Exclusion criteria after the Run-in period

1. Basal insulin proportion > 55% of daily insulin dose.
2. Children with any symptoms of an infectious disease or acutely sick during the last two weeks.
3. Estimated HbA1c > 8.5% based on the 14-days CGM report.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Standard-bolus

Active Comparator group

Description:

Standard boluses for all meal

Treatment:

Device: Standard bolus

Dual-bolus

Experimental group

Description:

Dual-bolus (50/50% with second part over 2 hours) for all meals after 6:00 p.m

Treatment:

Device: Dual-bolus