Joint Application of Human Insulin and Rapid Insulin Analogue in Control of Postprandial Glycemia

Not Applicable

• Conditions: Diabetes Mellitus, Type 1

• Registration Number: NCT01088451
• Lead Sponsor: University Hospital Hradec Kralove

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-12
• Status Verified: 2010-02
• Study First Submitted: 2010-02-11
• Primary Completion: 2010-03
• Study First Submitted QC: 2010-03-16
• Last Update Submitted: 2010-03-16
• Study First Posted: 2010-03-17
• Last Update Posted: 2010-03-17
• Study Completion: 2010-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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.	one month

Secondary Outcome Measures

Name	Time	Method
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.	one month

Trial Locations

Locations (1)

University Hospital Hradec Králové; 🇨🇿 Hradec Králové, Czech Republic