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

Diabeteszentrum Bad Lauterberg im Harz

Status: Unknown

Conditions: Fasting

Treatments: Other: Fasting day

Study type: Interventional

Funder types: Other

Identifiers

NCT02667769

DZBL-2014-2

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

20 participants in 2 patient groups

Fasting day without any food

Other group

Description:

Complete fasting: On a fast day under this Protocol no solid food may be eaten unless it is solid, medically prescribed part of a bedtime snack just before falling asleep (which must sometimes be to prevent nocturnal hypoglycaemia with injection of basal insulin before going to sleep) , Otherwise, the patient have ad libitum access to mineral water and unsweetened tea (possibly a fluid intake restriction should be considered for other diseases).

Treatment:

Other: Fasting day

Fasting day with calorie- & carbohydrate-free food

Other group

Description:

During a fasting day for this protocol, patients may calories in unlimited quantity and (with calorie-free dressing) Take carb food like tomatoes, cucumbers, lettuce to be, both during meal periods and in between, if desired.

Treatment:

Other: Fasting day