Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes
NCT ID: NCT04668612
Last Updated: 2021-04-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2020-09-04
2021-06-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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Standard-bolus
Standard boluses for all meal
Standard bolus
Standard boluses for all meals
Dual-bolus
Dual-bolus (50/50% with second part over 2 hours) for all meals after 6:00 p.m
Dual-bolus
Dual-bolus (50/50% with second part over 2 hours) for all meals after 6:00 p.m.
Interventions
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Dual-bolus
Dual-bolus (50/50% with second part over 2 hours) for all meals after 6:00 p.m.
Standard bolus
Standard boluses for all meals
Eligibility Criteria
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Inclusion Criteria
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
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.
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.
7 Years
18 Years
ALL
No
Sponsors
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Estonian Research Council
UNKNOWN
Tartu University Hospital
OTHER
Responsible Party
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Aleksandr Peet
pediatric endocrinologist, MD, PhD
Locations
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Tartu University Hospital
Tartu, , Estonia
Countries
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Other Identifiers
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1.1
Identifier Type: -
Identifier Source: org_study_id
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