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

Not Applicable

• Conditions: Type 1 Diabetes
• Interventions: Device: Standard bolus; Device: Dual-bolus

• Registration Number: NCT04668612
• Lead Sponsor: Tartu University Hospital

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2020-09-04
• Study First Submitted: 2020-11-30
• Study First Submitted QC: 2020-12-13
• Study First Posted: 2020-12-16
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-30
• Last Update Posted: 2021-04-01
• Primary Completion: 2021-05-20
• Study Completion: 2021-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Time in range (TIR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner.	14 days	To compare time in range duration during 2 weeks receiving dual-wave bolus versus standard bolus for dinner. Proportion of time in range (3.9-10 mmol/L) will be measured.

Secondary Outcome Measures

Name	Time	Method
Time below range (TBR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner.	14 days	Time below range (TBR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner. Proportion of time below range (\<3,9 mmol/L)
Time above range (TAR) during 2 weeks receiving dual-wave bolus versus standard bolus	14 days	Time above range (TAR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner. Proportion of time below range (\>10.0 mmol/L)

Trial Locations

Locations (1)

Tartu University Hospital; 🇪🇪 Tartu, Estonia