Effect of Dual-wave Insulin Bolus on Postprandial Glycaemia
Primary Purpose
Type1 Diabetes
Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
insulin
Sponsored by
About this trial
This is an interventional treatment trial for Type1 Diabetes focused on measuring Type 1 diabetes, Dual-wave bolus, Postprandial euglycaemia
Eligibility Criteria
Inclusion Criteria:
- duration of T1D >3 years, CSII therapy for at least 1 year, good to moderate glycaemic control, as evidenced by HbA1c levels <8.5% (69 mmol/mol).
Exclusion Criteria:
- Subjects with eating disorders, food allergy, celiac disease and known diabetic complications
Sites / Locations
- Unit of Pediatric Endocrinology, Diabetes and Metabolism-4th Department of Pediatrics, Medical School of Aristotle University of Thessaloniki
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Adolescents with T1D on CSII
Healthy adolescents
Arm Description
3 standard meals with varying composition were consumed and combined with alternative types of D/WB and S/WB All participants used the rapid-acting insulin analogue aspart (NovoRapid®, Novonordisk A/S, Bagsvaerd, Denmark) and total insulin dose administered to each one for each test meal was known in advance, according to the insulin to carbohydrate ratio that had been calculated during the 2-week pre-study period.
3 standard meals with varying composition were consumed
Outcomes
Primary Outcome Measures
post-prandial euglycaemia (PPG)
the impact of different types of D/WB on PPG after three given meals, in adolescents with T1D on CSII. In order to achieve that, three different meals were designed and combined with alternative types of boluses, D/WB and S/WB
Secondary Outcome Measures
Full Information
NCT ID
NCT03179280
First Posted
May 4, 2017
Last Updated
June 6, 2017
Sponsor
Aristotle University Of Thessaloniki
1. Study Identification
Unique Protocol Identification Number
NCT03179280
Brief Title
Effect of Dual-wave Insulin Bolus on Postprandial Glycaemia
Official Title
Effect of Dual-wave Insulin Bolus on Postprandial Glycaemia According to the Composition of the Meal in Adolescents With Type 1 Diabetes Using Continuous Subcutaneous Insulin Infusion
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Completed
Study Start Date
March 2011 (Actual)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aristotle University Of Thessaloniki
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
A study was conducted in adolescents with type 1 diabetes (T1D) examining the effect of different bolus types on 6-h postprandial glucose levels after the consumption of 3 standard meals with varying composition. Participants were asked to consume 10 different combinations of meal and bolus type.
Detailed Description
The nutritional recommendations of children and adolescents with T1D should be similar to those of healthy people in order to achieve the desirable growth. Not only the carbohydrates' intake is underlined according to special guidelines by Canadian diabetes association, American diabetes association and International Society for Paediatric and Adolescent Diabetes but also proteins and fats are suggested to be taken into consideration in the management of T1D. In order to reach the desirable euglycemic control, children and adolescents can use multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII). By using the CSII the insulin can be administrated in three different patterns; as a normal bolus, as a dual wave bolus and as a square wave bolus. Dual wave insulin bolus (D/WB) is suggested as the most suitable option based on the effects that is having after meals with different content of carbohydrates, fats and proteins. The aim of this study was to evaluate the impact of different types of D/WB on PPG after 3 given meals, in adolescents with T1D on CSII. In order to achieve that, 3 different meals were designed and combined with alternative types of boluses, D/WB and square wave insulin bolus (S/WB).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type1 Diabetes
Keywords
Type 1 diabetes, Dual-wave bolus, Postprandial euglycaemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Adolescents with T1D on CSII
Arm Type
Active Comparator
Arm Description
3 standard meals with varying composition were consumed and combined with alternative types of D/WB and S/WB All participants used the rapid-acting insulin analogue aspart (NovoRapid®, Novonordisk A/S, Bagsvaerd, Denmark) and total insulin dose administered to each one for each test meal was known in advance, according to the insulin to carbohydrate ratio that had been calculated during the 2-week pre-study period.
Arm Title
Healthy adolescents
Arm Type
No Intervention
Arm Description
3 standard meals with varying composition were consumed
Intervention Type
Drug
Intervention Name(s)
insulin
Other Intervention Name(s)
NovoRapid
Intervention Description
All participants used the rapid-acting insulin analogue aspart (NovoRapid®, Novonordisk A/S, Bagsvaerd, Denmark) and total insulin dose administered to each one for each test meal was known in advance, according to the insulin to carbohydrate ratio that had been calculated during the 2-week pre-study period.
Primary Outcome Measure Information:
Title
post-prandial euglycaemia (PPG)
Description
the impact of different types of D/WB on PPG after three given meals, in adolescents with T1D on CSII. In order to achieve that, three different meals were designed and combined with alternative types of boluses, D/WB and S/WB
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
11 Years
Maximum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
duration of T1D >3 years, CSII therapy for at least 1 year, good to moderate glycaemic control, as evidenced by HbA1c levels <8.5% (69 mmol/mol).
Exclusion Criteria:
Subjects with eating disorders, food allergy, celiac disease and known diabetic complications
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Assimina Galli-Tsinopoulou, Ass Prof
Organizational Affiliation
Unit of Pediatric Endocrinology, Diabetes and Metabolism-4th Department of Pediatrics, Medical School of Aristotle University of Thessaloniki
Official's Role
Study Chair
Facility Information:
Facility Name
Unit of Pediatric Endocrinology, Diabetes and Metabolism-4th Department of Pediatrics, Medical School of Aristotle University of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
56403
Country
Greece
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
20144405
Citation
Heinemann L. Insulin pump therapy: what is the evidence for using different types of boluses for coverage of prandial insulin requirements? J Diabetes Sci Technol. 2009 Nov 1;3(6):1490-500. doi: 10.1177/193229680900300631.
Results Reference
result
PubMed Identifier
11943004
Citation
Chase HP, Saib SZ, MacKenzie T, Hansen MM, Garg SK. Post-prandial glucose excursions following four methods of bolus insulin administration in subjects with type 1 diabetes. Diabet Med. 2002 Apr;19(4):317-21. doi: 10.1046/j.1464-5491.2002.00685.x.
Results Reference
result
PubMed Identifier
15575341
Citation
Lee SW, Cao M, Sajid S, Hayes M, Choi L, Rother C, de Leon R. The dual-wave bolus feature in continuous subcutaneous insulin infusion pumps controls prolonged post-prandial hyperglycaemia better than standard bolus in Type 1 diabetes. Diabetes Nutr Metab. 2004 Aug;17(4):211-6.
Results Reference
result
Links:
URL
http://2011.ispad.org/materials/final_program.pdf
Description
Summary of the results announced at the 37th annual meeting of International Society for Pediatric and Adolescent Diabetes (ISPAD), to be held in Miami Beach October 19-22, 2011.
Available IPD and Supporting Information:
Available IPD/Information Type
Poster at an international meeting
Available IPD/Information URL
http://2011.ispad.org/materials/final_program.pdf
Learn more about this trial
Effect of Dual-wave Insulin Bolus on Postprandial Glycaemia
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