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

NCT02667769 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2016-08-16

No results posted yet for this study

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.

Conditions

  • Fasting

Interventions

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.

Sponsors & Collaborators

  • Diabeteszentrum Bad Lauterberg im Harz

    lead OTHER

Principal Investigators

  • Michael A. Nauck, Prof. · Diabeteszentrum Bad Lauterberg

Study Design

Allocation
RANDOMIZED
Masking
NONE
Model
CROSSOVER

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-08-31
Primary Completion
2016-06-30

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02667769 on ClinicalTrials.gov