Comparison of Two Protocols on the Implementation of a Fasting Day in Type 1 Diabetes
This trial is active, not recruiting.
|Sponsor||Diabeteszentrum Bad Lauterberg im Harz|
|Start date||August 2014|
|End date||June 2016|
|Trial size||20 participants|
|Trial identifier||NCT02667769, DZBL-2014-2|
This is a prospective study with a "crossover design", where fasting with a day of complete fasting and a fasting day with the permission intake of calories- and carbohydrate-free foods are compared in a randomized order. Underlying hypothesis is that at the same basal insulin substitution with the fasting of both protocols , no significant differences in the glucose-day or -night profiles revealed. So the same conclusions regarding the "consistency" of basal insulin dosing revealed during the implementation of the part of patients is rated as more pleasant when calories and carbohydrates-free food are allowed.
|Intervention model||crossover assignment|
Plasma glucose day- and night profiles
time frame: 24 hours
Male or female participants of any age.
Inclusion Criteria: - Type 1 diabetes - Basal insulin substitution with neutrales Protamin Hagedorn (NPH) -insulin (at least twice a day), insulin detemir (twice a day), insulin glargine (once or twice a day) or with insulin pump - Diabetes duration > 2 years - Body-mass-index between 19 and 35 kg/m², including - written consent Exclusion Criteria: - No pregnancy in woman
|Official title||Comparison of Two Protocols on the Implementation of a Fasting Day to Check the Basal Insulin Replacement in Type 1 Diabetes: Complete Fasting Compared to the Permission for Carbohydrate- and Calorie-free Food|
|Principal investigator||Michael A. Nauck, Prof.|
Call for more information