Making Ramadhan Fasting a Safer Experience With Technology Study

• Register: ClinicalTrials.gov
• Last refreshed on: 9 January 2017
• Main ID: NCT02189135
• Date of registration: 09/07/2014
• Prospective Registration: No
• Primary sponsor: Monash University
• Public title: Making Ramadhan Fasting a Safer Experience With Technology Study
• Scientific title: Making Ramadhan Fasting a Safer Experience With Technology Study
• Date of first enrolment: July 2014
• Target sample size: 85
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02189135
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
• Phase: Phase 4

Countries of recruitment

Malaysia

Contacts

• Name: Shaun Lee, PhD
• Affiliation: Monash University

Key inclusion & exclusion criteria

Inclusion Criteria:

- Type 2 diabetes diagnosed by a physician at least six months prior to study
enrollment. This will be determined via self-report with verification (medical
records, current treatment, or test results meeting the 2009 Malaysian Clinical
Practice Guideline for Management of Type 2 Diabetes Mellitus (4th edition) criteria
of fasting blood glucose > 7.0 mmol/L , symptoms of hyperglycaemia with casual plasma
glucose >11.1mmol/L or two-hour plasma glucose >11.1mmol/L after a 75gram oral
glucose load)

- HbA1c of > 7.5% but less than 11.0% within the most recent 3 months. Individuals with
HbA1c exceeding this level may require more urgent care and as such will be asked to
seek treatment

- Aged 18 - 75 years are eligible. Participants older than 75 years of age are excluded
due to the increased risk of competing mortality and potential safety concerns
related to hypoglycaemia

- Willing or has an intention to fast for at least 15 days during Ramadan

- Access to internet and an e-mail address , or access to a smartphone with 3G services
in the intervention group

- Not pregnant or history of heart diseases, serious illness, cancer diagnosis or any
other conditions that can impede participation

Exclusion Criteria:

- Unable or unwilling to give informed consent or communicate with local study staff

- Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder

- Hospitalization for depression in past six months

- Plans to relocate to an area or travel plans that do not permit full participation in
the study

- Lack of support from primary health care provider or family members

- History of bariatric surgery, small bowel resection, or extensive bowel resection

- Currently pregnant or nursing

- Cancer: requiring treatment in the past five years, except for non-melanoma skin
cancers or cancers that have clearly been cured or in the opinion of the investigator
carry an excellent prognosis (e.g., Stage 1 cervical cancer)

- Cardiovascular disease (heart attack or procedure within the past three months or
participation in a cardiac rehabilitation program within last three months, stroke or
history/treatment for transient ischemic attacks in the past three months, or
documented history of pulmonary embolus in past six months)

- Other medical, psychiatric, or behavioral factors that in the judgment of the
Principal Investigator may interfere with study participation or the ability to
follow the intervention protocol



Age minimum: 18 Years
Age maximum: 75 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Diabetes Mellitus, Non-Insulin-Dependent

Intervention(s)

Device: Telemedicine

Primary Outcome(s)

Number of patients with hypoglycaemia in usual care versus telemedicine during Ramadan [Time Frame: Week 4]

Secondary Outcome(s)

Total number of hypoglycaemic rates in usual care versus telemedicine during Ramadan [Time Frame: Week 4]

Glycaemic control of patients measured with HbA1c in patients under usual care versus telemedicine from baseline to end of treatment [Time Frame: Week 12]

Mean change in fructosamine from start of Ramadan (day -1) to end of Ramadan (day 29) in usual care versus telemedicine [Time Frame: Week 4]

Total number of hypoglycaemic rates in usual care versus telemedicine from baseline to end of treatment [Time Frame: Week 12]

Secondary ID(s)

MRFAST

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

SEGi University