Type 1 Diabetes
Conditions
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.
Interventions
DEVICEDual-bolus
Dual-bolus (50/50% with second part over 2 hours) for all meals after 6:00 p.m.
DEVICEStandard bolus
Standard boluses for all meals
Sponsors
Estonian Research Council
Tartu University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Randomized open-label single-center crossover clinical study
Eligibility
Sex/Gender
ALL
Age
7 Years to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
Estonia
Outcome results
None listed