Status:
UNKNOWN
Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes
Lead Sponsor:
Tartu University Hospital
Collaborating Sponsors:
Estonian Research Council
Conditions:
Type 1 Diabetes
Eligibility:
All Genders
7-18 years
Phase:
NA
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 we...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
September 4 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 30 2021
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04668612
Start Date
September 4 2020
End Date
June 30 2021
Last Update
April 1 2021
Active Locations (1)
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1
Tartu University Hospital
Tartu, Estonia, 51014