Joint Application of Human Insulin and Rapid Insulin Analogue in Control of Postprandial Glycemia (CPIT)
Recruitment status was Active, not recruiting
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Joint Application of Human Insulin and Rapid Insulin Analogue in Control of Postprandial Glycemia|
- 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 ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
|Study Start Date:||December 2009|
|Estimated Study Completion Date:||September 2010|
|Estimated Primary Completion Date:||March 2010 (Final data collection date for primary outcome measure)|
Drug: Combined prandial insulin therapy (CPIT)
Please refer to this study by its ClinicalTrials.gov identifier: NCT01088451
|University Hospital Hradec Králové|
|Hradec Králové, Czech Republic, 50005|