Clinical trial NCT03179280: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type1 Diabetes
Keywords: Type 1 diabetes
Dual-wave bolus
Postprandial euglycaemia
Lead sponsor: Aristotle University Of Thessaloniki
Sponsor class: OTHER
First posted: 2017-06-07
Enrollment: 10
Sex: ALL
Minimum age (years): 11
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: post-prandial euglycaemia (PPG)
timeFrame: 3 days
Secondary outcomes:
Other outcomes:
Locations:
city: Thessaloniki
country: Greece
facility: Unit of Pediatric Endocrinology, Diabetes and Metabolism-4th Department of Pediatrics, Medical School of Aristotle University of Thessaloniki
Study officials:
affiliation: Unit of Pediatric Endocrinology, Diabetes and Metabolism-4th Department of Pediatrics, Medical School of Aristotle University of Thessaloniki
name: Assimina Galli-Tsinopoulou, Ass Prof
role: STUDY_CHAIR
References:
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.
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.
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.