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A Randomized Control Trial in People With Type 1 Diabetes Who Will Fast Ramadan: Does Insulin Timing and Dose Matter?

NCT04135248 · Status: UNKNOWN · Type: OBSERVATIONAL · Enrollment: 50

Last updated 2019-10-22

No results posted yet for this study

Summary

Fasting Ramadan is one of the five pillars of Islam and requested only from healthy adults to abstain from eating and drinking from sunrise to sunset. People with type 1 diabetes mellitus (TIDM) are exempted from fasting, as their chronic condition could be adversely affected by fasting. Nevertheless, many insist on fasting and it has been experienced and advocated that with proper education and follow-up with health care providers, people with uncomplicated T1DM could safely fast Ramadan.

Adopted IDF-DAR guidelines for people with diabetes planning to fast Ramadan are available but are based on opinions and largely untested. These current guidelines recommend a significant reduction in insulin doses and a change of the timing of basal insulin and highlight the increased risk of hypoglycemia. Our local DAFNE patient's experience with fasting during the past years points towards no significant changes in insulin timing with minor reductions of insulin without a significant increase in the risk of hypoglycemia. There is no randomized control trial to test the efficacy of the IDF-DAR guidelines specifically looking at changing basal insulin timing This study aims to assess whether insulin doses require reduction and change of timing during Ramadan. We aim to compare the effectiveness and safety of two management strategies. This will help to provide robust guidelines to help both health care professionals and people with type 1 diabetes

Conditions

  • Type 1 Diabetes Mellitus

Sponsors & Collaborators

  • Dasman Diabetes Institute

    lead OTHER

Principal Investigators

  • Ebaa Al-Ozairi, MBChB(UK) · Dasman Diabetes Institute, Kuwait

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-04-18
Primary Completion
2019-12-30
Completion
2020-04-17

Countries

  • Kuwait

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 NCT04135248 on ClinicalTrials.gov