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

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

Detailed Description
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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.

Official Title
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Lowering Postprandial Hyperglycemia With Dual-wave Insulin Boluses in Children With Type 1 Diabetes

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: Dual-bolus
* Device: Standard bolus


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children aged 7-18 years treated at the Children's Clinic of Tartu University Hospital for type1 diabetes. Insulin pump and CGM initiated at least 3 months prior to the recruitment. Estimated HbA1c based on the 14-days CGM report above 8.5%. Daily insulin dose of more than 0.5 international units per kilogram. Exclusion Criteria: Subjects with known diabetes complications. Elevated tissue transglutaminase IgA antibodies in the last two years. Children who developed an acute viral infections during the week preceding the recruitment. Exclusion criteria after the Run-in period Basal insulin proportion > 55% of daily insulin dose. Children with any symptoms of an infectious disease or acutely sick during the last two weeks. Estimated HbA1c > 8.5% based on the 14-days CGM report.

Ages Eligible for Study
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Minimum Age: 7 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Randomized open-label single-center crossover clinical study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard-bolus<br>Standard boluses for all meal | Device: Standard bolus<br>* Standard boluses for all meals<br>|
| Experimental: Dual-bolus<br>Dual-bolus (50/50% with second part over 2 hours) for all meals after 6:00 p.m | Device: Dual-bolus<br>* Dual-bolus (50/50% with second part over 2 hours) for all meals after 6:00 p.m.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time in range (TIR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner. | 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. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time below range (TBR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner. | 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) | 14 days | 
| Time above range (TAR) during 2 weeks receiving dual-wave bolus versus standard bolus | 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) | 14 days |