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

NCT01088451 | Unknown

• 2 other identifiers: 200912S24MZO00179906-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 1

Keywords

Diabetes Mellitus, Type 1; Prandial Glycemia; Rapid Acting Insulin Analogue; Human Insulin

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Interventions

Combined prandial insulin therapy (CPIT) DRUG

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.

Eligibility Criteria

• Age: 12 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• acute illness and celiac disease, but not euthyroid autoimmune thyroiditis, defined as thyroid stimulating hormone (TSH)\<4 mIU/l.

Sponsors & Collaborators

• University Hospital Hradec Kralove: lead

Study Sites (1)

University Hospital Hradec Králové

Hradec Králové, 50005, Czechia

Location

Related Publications (14)

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  PMID: 12610053 BACKGROUND

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  PMID: 12081850 BACKGROUND

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  PMID: 15182401 BACKGROUND

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  PMID: 14652382 BACKGROUND

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  PMID: 19079901 BACKGROUND

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  PMID: 10205584 BACKGROUND

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  PMID: 18509207 BACKGROUND

• Pankowska E, Szypowska A, Lipka M, Szpotanska M, Blazik M, Groele L. Application of novel dual wave meal bolus and its impact on glycated hemoglobin A1c level in children with type 1 diabetes. Pediatr Diabetes. 2009 Aug;10(5):298-303. doi: 10.1111/j.1399-5448.2008.00471.x. Epub 2008 Oct 20.

  PMID: 19175902 BACKGROUND

• Report of the Expert Committee on the Diagnosis and Classification of Diabetes Mellitus. Diabetes Care. 1997 Jul;20(7):1183-97. doi: 10.2337/diacare.20.7.1183. No abstract available.

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  PMID: 18547233 BACKGROUND

• Workgroup on Hypoglycemia, American Diabetes Association. Defining and reporting hypoglycemia in diabetes: a report from the American Diabetes Association Workgroup on Hypoglycemia. Diabetes Care. 2005 May;28(5):1245-9. doi: 10.2337/diacare.28.5.1245. No abstract available.

  PMID: 15855602 BACKGROUND

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  PMID: 12081815 BACKGROUND

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  PMID: 15647580 BACKGROUND

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  PMID: 11909787 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Hyperinsulinism

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 11, 2010
• First Posted: March 17, 2010
• Study Start: December 1, 2009
• Primary Completion: March 1, 2010
• Study Completion: September 1, 2010
• Last Updated: March 17, 2010

Record last verified: 2010-02

Locations

CZ (1)