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

Type 1 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04668612
• Other study ID #: 1.1
• Status: Active, not recruiting
• Phase: N/A
• Start date: September 4, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: March 2021
• Source: Tartu University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: June 30, 2021
• Est. primary completion date: May 20, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 7 Years to 18 Years

Eligibility

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.

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Device:
• 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

Locations

Country	Name	City	State
Estonia	Tartu University Hospital	Tartu

Sponsors (2)

Lead Sponsor	Collaborator
Tartu University Hospital	Estonian Research Council

Country where clinical trial is conducted

Estonia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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