Comparison of Two Protocols on the Implementation of a Fasting Day in Type 1 Diabetes

Fasting Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02667769
• Other study ID #: DZBL-2014-2
• Status: Active, not recruiting
• Phase: N/A
• First received: January 26, 2016
• Last updated: August 15, 2016
• Start date: August 2014

Study information

• Verified date: August 2016
• Source: Diabeteszentrum Bad Lauterberg im Harz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Fasting

Intervention

Other:
• Fasting day
A day of fasting started at 18.00 clock with a blood glucose test and is only started when on the same day no significant hypoglycemia (blood glucose <55 mg / dl) occurred, and when at 18.00 clock the blood sugar in the defined target range (70-180 mg / dl) is. Carried out during the fasting day standardized blood samples for measurement of plasma glucose with an appropriate laboratory method at 18.00, 20:00, 22:00, 12:00, 2:00, 4:00, 6:45, 9:00, 12:00, 14:00 and again at 18.00 clock. Because the determination of plasma glucose in the laboratory will take some time, is always for guidance and also measured with a fast measurement method, in order to treat at high levels of blood sugar with additional insulin correction, and to treat hypoglycaemia low blood sugar or to prevent hypoglycaemia.

Locations

Country	Name	City	State
Germany	Diabeteszentrum Bad Lauterberg	Bad Lauterberg	Niedersachsen

Sponsors (1)

Lead Sponsor	Collaborator
Diabeteszentrum Bad Lauterberg im Harz

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plasma glucose day- and night profiles		24 hours	No