NCT04668612

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

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Tartu University Hospital · Academic / Other
• Sex: All
• Age: 7 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Type 1 Diabetes

Interventions

Type	Name	Description
DEVICE	Dual-bolus	Dual-bolus (50/50% with second part over 2 hours) for all meals after 6:00 p.m.
DEVICE	Standard bolus	Standard boluses for all meals

Timeline

• Start date: 2020-09-04
• Primary completion: 2021-05-20
• Completion: 2021-06-30
• First posted: 2020-12-16
• Last updated: 2021-04-01

Locations

1 site across 1 country: Estonia

Regulatory

• FDA-regulated device study