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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2010 by University Hospital Hradec Kralove.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01088451
First Posted: March 17, 2010
Last Update Posted: March 17, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
University Hospital Hradec Kralove
February 11, 2010
March 17, 2010
March 17, 2010
December 2009
March 2010   (Final data collection date for primary outcome 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 ]
Same as current
No Changes Posted
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 ]
Same as current
Not Provided
Not Provided
 
Joint Application of Human Insulin and Rapid Insulin Analogue in Control of Postprandial Glycemia
Joint Application of Human Insulin and Rapid Insulin Analogue in Control of Postprandial Glycemia

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.

Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Diabetes Mellitus, Type 1
Drug: Combined prandial insulin therapy (CPIT)
Combined prandial insulin therapy (CPIT) applies individual combination of rapid insulin analogue and human insulin according subject's individual estimation of the type of carbohydrates in concrete mixed-meal, based on thorough education. In this study subjects use two applicators, giving two injections before main meals as per basal-bolus therapy. Insulin aspart (Novorapid, Novo Nordisk) and human insulin (Actrapid, Novo Nordisk) are used.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
20
September 2010
March 2010   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
12 Years to 25 Years   (Child, Adult)
No
Contact information is only displayed when the study is recruiting subjects
Czech Republic
 
 
NCT01088451
200912S24
MZO00179906-01 ( Other Grant/Funding Number: University Hospital Hradec Králové )
No
Not Provided
Not Provided
David Neumann/Principal Investigator, University Hospital Hradec Králové
University Hospital Hradec Kralove
Not Provided
Not Provided
University Hospital Hradec Kralove
February 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP