Status:
COMPLETED
Making Ramadhan Fasting a Safer Experience With Technology Study
Lead Sponsor:
Monash University
Collaborating Sponsors:
Segi University
Conditions:
Diabetes Mellitus, Non-Insulin-Dependent
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief Summary
Type 2 diabetes mellitus (T2DM) is a chronic condition that is one of the major causes of illness, disability, and death in Malaysia with an increasing prevalence. Despite the best effort, only 1 in 3...
Detailed Description
Eligible participants will be assigned based upon their participating site. Treatment assignments are unmasked. Intervention group will utilize a web enabled glucometer manufactured by Entra Health Sy...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2016
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT02189135
Start Date
July 1 2014
End Date
September 1 2016
Last Update
December 16 2016
Active Locations (1)
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1
Klinik Kesihatan Pandamaran
Klang, Selangor, Malaysia, 42000