Overview

This trial is active, not recruiting.

Condition diabetes mellitus, type 1
Treatment combined prandial insulin therapy (cpit)
Sponsor University Hospital Hradec Kralove
Start date December 2009
End date March 2010
Trial size 20 participants
Trial identifier NCT01088451, 200912S24, MZO00179906-01

Summary

Postprandial glycemic control is essential for diabetes compensation. Insulin pump therapy control blood glucose released in response to both high and low glycemic index carbohydrates in a mixed diet using normal, square and dual-wave boluses. The investigators hypothesize a mixture of rapid insulin analogue and human insulin has the same effect.

This pilot prospective cohort study replaces basal-bolus therapy of diabetic subjects by combined prandial application of insulin aspart and human insulin. Mixed-meals with high, both high and low and low glycemic index carbohydrates are covered by 3:1, 1:1 and 1:3 ratios of analogue to human insulin mixture. Subjects are followed by continuous glucose monitor for six days (Phase One), changing between the experimental or their standard protocol for insulin injection on consecutive days. The outcome was measured by comparing average glycemia and areas under the curve of sample meals, which are doughnut, pizza and mixed vegetable salad. The next three-to-four week period of therapy was evaluated by glycated hemoglobin before and after the intervention (Phase Two).

Expected outcomes are postprandial and complex improvement of diabetes control, similarly to the insulin pump therapy.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
Differences in mean blood glucose concentrations and the pattern of fluctuation on control and study days; and changes in the glycated hemoglobin A1c after the study period. Occurrence of side effects especially hypoglycemic episodes.
time frame: one month

Secondary Outcomes

Measure
The difference in postprandial areas under the curve when comparing conventional therapy and experimental combined prandial insulin therapy in the 5 to 6 hours following meal ingestion, taking into account the glycemic index profile of the meal.
time frame: one month

Eligibility Criteria

Male or female participants from 12 years up to 25 years old.

Inclusion criteria - pubertal children, adolescents, young adults able to follow instructions, regardless of their long-time compliance - willing to undertake a prandial application of two kinds of insulin using two standard insulin applicators. - willing to complete detailed meal, insulin and/or combination insulin and hypoglycemia diary throughout the study. Exclusion criteria: - acute illness and celiac disease, but not euthyroid autoimmune thyroiditis, defined as thyroid stimulating hormone (TSH)<4 mIU/l.

Additional Information

Official title Joint Application of Human Insulin and Rapid Insulin Analogue in Control of Postprandial Glycemia
Trial information was received from ClinicalTrials.gov and was last updated in March 2010.
Information provided to ClinicalTrials.gov by University Hospital Hradec Kralove.