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

Primary Purpose

Type 1 Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
Estonia
Study Type
Interventional
Intervention
Dual-bolus
Standard bolus
Sponsored by
Tartu University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

7 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Tartu University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard-bolus

Dual-bolus

Arm Description

Standard boluses for all meal

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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)

Full Information

First Posted
November 30, 2020
Last Updated
March 30, 2021
Sponsor
Tartu University Hospital
Collaborators
Estonian Research Council
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1. Study Identification

Unique Protocol Identification Number
NCT04668612
Brief Title
Dual-wave Boluses in Children With Type 1 Diabetes Insulin Boluses in Children With Type 1 Diabetes
Official Title
Lowering Postprandial Hyperglycemia With Dual-wave Insulin Boluses in Children With Type 1 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Unknown status
Study Start Date
September 4, 2020 (Actual)
Primary Completion Date
May 20, 2021 (Anticipated)
Study Completion Date
June 30, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tartu University Hospital
Collaborators
Estonian Research Council

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Model Description
Randomized open-label single-center crossover clinical study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard-bolus
Arm Type
Active Comparator
Arm Description
Standard boluses for all meal
Arm Title
Dual-bolus
Arm Type
Experimental
Arm Description
Dual-bolus (50/50% with second part over 2 hours) for all meals after 6:00 p.m
Intervention Type
Device
Intervention Name(s)
Dual-bolus
Intervention Description
Dual-bolus (50/50% with second part over 2 hours) for all meals after 6:00 p.m.
Intervention Type
Device
Intervention Name(s)
Standard bolus
Intervention Description
Standard boluses for all meals
Primary Outcome Measure Information:
Title
Time in range (TIR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner.
Description
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.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Time below range (TBR) during 2 weeks receiving dual-wave bolus versus standard bolus for dinner.
Description
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 Frame
14 days
Title
Time above range (TAR) during 2 weeks receiving dual-wave bolus versus standard bolus
Description
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)
Time Frame
14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Criteria: 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.
Facility Information:
Facility Name
Tartu University Hospital
City
Tartu
ZIP/Postal Code
51014
Country
Estonia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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