Ignite Creation Date:
2025-12-26 @ 11:08 AM
Ignite Modification Date:
2025-12-29 @ 8:29 AM
Study NCT ID:
NCT04668612
Status:
UNKNOWN
Last Update Posted:
2021-04-01
First Post:
2020-11-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes
Sponsor:
Tartu University Hospital
Organization:
Study Overview
Official Title:
Lowering Postprandial Hyperglycemia With Dual-wave Insulin Boluses in Children With Type 1 Diabetes
Status:
UNKNOWN
Status Verified Date:
2021-03
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: