The Necessity of an Injection-Meal-Interval in Patients With Type 2 Diabetes Mellitus and Therapy With Human Insulin
NCT ID: NCT00529165
Last Updated: 2009-01-14
Study Results
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Basic Information
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COMPLETED
NA
100 participants
INTERVENTIONAL
2007-07-31
2009-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
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A
with injection-meal-interval,cross over after 3 month, than without injection-meal-interval for 3 month
injection-meal-interval
The patient injects human insulin (as Actrapid from NovoNordisc) as usual in their insulin routine. The injection is subcutaneous and the dosage is dependent on the blood glucose monitoring. Patients will inject insulin previous every meal, with the following differences:
1. Group A: with injection-meal-interval: 50 patients educated to inject the insulin with an injection-meal-interval of 15 minutes
2. Group B: without injection-meal-interval: 50 patients educated to inject the insulin without injection-meal-interval
Cross-over will occur to the other group after 12 weeks. The follow up is 28 weeks.
B
without injection-meal-interval,cross over after 3 month, than with injection-meal-interval for 3 month
injection-meal-interval
The patient injects human insulin (as Actrapid from NovoNordisc) as usual in their insulin routine. The injection is subcutaneous and the dosage is dependent on the blood glucose monitoring. Patients will inject insulin previous every meal, with the following differences:
1. Group A: with injection-meal-interval: 50 patients educated to inject the insulin with an injection-meal-interval of 15 minutes
2. Group B: without injection-meal-interval: 50 patients educated to inject the insulin without injection-meal-interval
Cross-over will occur to the other group after 12 weeks. The follow up is 28 weeks.
Interventions
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injection-meal-interval
The patient injects human insulin (as Actrapid from NovoNordisc) as usual in their insulin routine. The injection is subcutaneous and the dosage is dependent on the blood glucose monitoring. Patients will inject insulin previous every meal, with the following differences:
1. Group A: with injection-meal-interval: 50 patients educated to inject the insulin with an injection-meal-interval of 15 minutes
2. Group B: without injection-meal-interval: 50 patients educated to inject the insulin without injection-meal-interval
Cross-over will occur to the other group after 12 weeks. The follow up is 28 weeks.
Eligibility Criteria
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Inclusion Criteria
* Aged 40 - 80 years
* Therapy with human insulin
Exclusion Criteria
* Nutrition disorders
* Psychological disease
* Body Mass Index (BMI) less than 25 kg/m\^2
* HbA1c greater than 9%
40 Years
80 Years
ALL
No
Sponsors
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University of Jena
OTHER
Responsible Party
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University Hospital Jena
Principal Investigators
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Ulrich A Mueller, Professor
Role: PRINCIPAL_INVESTIGATOR
University of Jena, department of internal medicine III
Locations
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Friedrich-Schiller-University, department of internal medicine III
Jena, , Germany
Countries
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References
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Muller N, Frank T, Kloos C, Lehmann T, Wolf G, Muller UA. Randomized crossover study to examine the necessity of an injection-to-meal interval in patients with type 2 diabetes and human insulin. Diabetes Care. 2013 Jul;36(7):1865-9. doi: 10.2337/dc12-1694. Epub 2013 Jan 22.
Muller N, Kloos C, Frank T, Ristow M, Wolf G, Muller UA. Prevalence of injection-meal interval usage and its association with variables of metabolic control in patients with Type 1 and Type 2 diabetes. Diabet Med. 2011 Feb;28(2):223-6. doi: 10.1111/j.1464-5491.2010.03172.x.
Other Identifiers
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ISRCTN04277490
Identifier Type: -
Identifier Source: org_study_id
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