A Randomized Control Trial in People With Type 1 Diabetes Who Will Fast Ramadan: Does Insulin Timing and Dose Matter?
|ClinicalTrials.gov Identifier: NCT04135248|
Recruitment Status : Enrolling by invitation
First Posted : October 22, 2019
Last Update Posted : October 22, 2019
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
|Condition or disease|
|Type 1 Diabetes Mellitus|
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||50 participants|
|Target Follow-Up Duration:||1 Year|
|Official Title:||A Randomized Control Trial in People With Type 1 Diabetes Mellitus Who Will Fast Ramadan: Does Insulin Timing and Dose Matter?|
|Actual Study Start Date :||April 18, 2019|
|Estimated Primary Completion Date :||December 30, 2019|
|Estimated Study Completion Date :||April 17, 2020|
Insulin management according to IDF-DAR guidelines (IDF-DAR arm) during the fasting period.
Insulin management according to local experience (DAFNE arm) during the fasting period.
- Percentage time spent in glucose range 4-10mmol/L [ Time Frame: 30 days ]FreeStlye libre software will be used to extract reports and data export readings of FSL readers. Data will be collected during the whole month of Ramadan fasting for the outcome measure.
- Rate of self-reported hypoglycaemia [ Time Frame: 30 days ]The data of self- reported hypoglycaemic episode will be collected daily basis by using telecommunication and whatsapp massage.
- Percentage time at the glucose level <4mmol/L or >10mmol/L [ Time Frame: 30 days ]The percentage time spent in hypo- and hyperglycemic range will be determined.
- Number of days needed to break the fast [ Time Frame: 30 days ]All patients will be instructed to break their fast if blood glucose reach 3.9 mmol/L confirmed with SBMG.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04135248
|Dasman Diabetes Institute|
|Kuwait, Dasman, Kuwait, 15462|
|Principal Investigator:||Ebaa Al-Ozairi, MBChB(UK)||Dasman Diabetes Institute, Kuwait|