Clinical Trials Directory

Trials / Completed

CompletedNCT03179280

Effect of Dual-wave Insulin Bolus on Postprandial Glycaemia

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
10 (actual)
Sponsor
Aristotle University Of Thessaloniki · Academic / Other
Sex
All
Age
11 Years – 20 Years
Healthy volunteers
Accepted

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).

Conditions

Interventions

TypeNameDescription
DRUGinsulinAll 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.

Timeline

Start date
2011-03-01
Primary completion
2011-05-01
Completion
2011-05-01
First posted
2017-06-07
Last updated
2017-06-07

Locations

1 site across 1 country: Greece

Source: ClinicalTrials.gov record NCT03179280. Inclusion in this directory is not an endorsement.