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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04135248
Recruitment Status : Enrolling by invitation
First Posted : October 22, 2019
Last Update Posted : October 22, 2019
Sponsor:
Information provided by (Responsible Party):
Dr. Ebaa Al Ozairi, Dasman Diabetes Institute

Brief 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


Condition or disease
Type 1 Diabetes Mellitus

Show Show detailed description

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Group/Cohort
IDF-DAR arm
Insulin management according to IDF-DAR guidelines (IDF-DAR arm) during the fasting period.
DAFNE arm
Insulin management according to local experience (DAFNE arm) during the fasting period.



Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Type 1 diabetes subjects, enrolled in the DAFNE center, Dasman Diabetes Institute, Kuwait.
Criteria

Inclusion Criteria:

  1. T1DM for 12 months or more
  2. Age >21 years old
  3. Current user of FSL and plan to use it during Ramadan
  4. HbA1C <10%
  5. Planning to fast Ramadan
  6. People with T1DM on insulin pump

Exclusion Criteria:

  1. Any significant diabetes-related complications including, but not limited to

    1. Any recent episode of severe hypoglycemia in the preceding 12 months
    2. Any recent DKA in the preceding 12 months
    3. Diabetic nephropathy with eGFR <60ml/minute/1.73m2
    4. Diabetic retinopathy ≥R2, ≥M1
    5. Peripheral neuropathy
    6. Active or recent foot ulcers
    7. HbA1c greater than 10%.
  2. Hypoglycaemia unawareness
  3. Pregnancy or plannig for pregnancy over the duration of the study
  4. Breast feeding
  5. Active malignancy
  6. Uncontrolled thyroid disorders
  7. Not able to attend study visits
  8. Not able or not willing to give written informed consent
  9. Not DAFNE graduates

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04135248


Locations
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Kuwait
Dasman Diabetes Institute
Kuwait, Dasman, Kuwait, 15462
Sponsors and Collaborators
Dasman Diabetes Institute
Investigators
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Principal Investigator: Ebaa Al-Ozairi, MBChB(UK) Dasman Diabetes Institute, Kuwait
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Responsible Party: Dr. Ebaa Al Ozairi, Chief Medical Officer, Dasman Diabetes Institute
ClinicalTrials.gov Identifier: NCT04135248    
Other Study ID Numbers: RA HM 2019-017
First Posted: October 22, 2019    Key Record Dates
Last Update Posted: October 22, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Dr. Ebaa Al Ozairi, Dasman Diabetes Institute:
Flash Glucose Monitoring, Time-in-Range, Fasting, Ramadan
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases