- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02189135
Making Ramadhan Fasting a Safer Experience With Technology Study
Study Overview
Status
Conditions
Intervention / Treatment
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 System (San Diego, California). The glucometer acts by automatically uploading any glucose readings to an online portal currently managed by Entra Health System. The web portal would host the patient's raw blood glucose in a logbook form and laboratory data. A summary of the patient's gylcaemic and metabolic control (lipid, blood pressure, weight) control, self-management skills as well as compliance to other key measures such as eye examination, screening for microvascular complications would also be provided if available. All patients in this intervention arm would be given a system-driven guidance on when to test their blood glucose based on their disease status, medication regimen, and time of poorest control so that the most useful, patient specific blood profile can be created and used for future self-management coaching for patient.
In the event that there is 3 continuous readings of hypoglycaemia (3.9mmol/L and below) or hyperglycaemia (11.1mmol/L and above), the system will automatically generate a message to inform the attending physician. The physician then has an option to use this information, but will remain responsible for all treatment decisions. For quality assurance, the physicians will be required to periodically review the participant's electronic logbook data and summary analysis reports, generated for patients and physicians. These feedbacks will be entered into an electronic logbook and captured real-time. A report will be generated summarizing the self-management actions for improving their diabetes control will be sent to the patients, physicians as well as family member every month. Each patient will also be informed that action plan serves as a pre-visit summary for the patient's next visit to their physician. In addition, the participant's family member(s) will also be invited to participate and if consented updated on the status of the participants blood glucose status periodically and be prompted whenever their glycaemic levels are beyond the target.
Participants assigned to the control group will continue to receive their usual medical care as they would from their physician or general practitioner including checking patient self-management blood glucose and log books. In addition, participants will receive standard lifestyle advice and will be given basic information on diabetes prevention, weight loss, diet, and exercise consistent with expert recommendation for a healthy lifestyle. Participants will also receive a glucose meter and supplies for 3 months. Participants will be told to use the glucose meter as recommended by their physicians. Control participants will also receive publically available literatures such as flyers and brochures.
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Selangor
-
Klang, Selangor, Malaysia, 42000
- Klinik Kesihatan Pandamaran
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Usual care
Usual care from physician/ doctor
|
|
Experimental: Telemedicine
Mobile wireless glucometer with feedback from physicians
|
The glucometer acts by automatically uploading any glucose readings to an online portal.
A summary of the patient's glycaemic and metabolic control, self-management skills as well as compliance to other key measures such as eye examination, screening for microvascular complications would also be provided if available.
All patients in this intervention arm would be given a system-driven guidance on when to test their blood glucose based on their disease status, medication regimen, and time of poorest control so that the most useful, patient specific blood profile can be created and used for future self-management coaching for patient
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Number of patients with hypoglycaemia in usual care versus telemedicine during Ramadan
Time Frame: Week 4
|
Week 4
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
Week 4
|
Total number of hypoglycaemic rates in usual care versus telemedicine during Ramadan
Time Frame: Week 4
|
Week 4
|
Total number of hypoglycaemic rates in usual care versus telemedicine from baseline to end of treatment
Time Frame: Week 12
|
Week 12
|
Glycaemic control of patients measured with HbA1c in patients under usual care versus telemedicine from baseline to end of treatment
Time Frame: Week 12
|
Week 12
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Shaun Lee, PhD, Monash University
Publications and helpful links
General Publications
- Lee JY, Wong CP, Tan CSS, Nasir NH, Lee SWH. Type 2 diabetes patient's perspective on Ramadan fasting: a qualitative study. BMJ Open Diabetes Res Care. 2017 May 8;5(1):e000365. doi: 10.1136/bmjdrc-2016-000365. eCollection 2017.
- Lee JY, Lee SW, Nasir NH, How S, Tan CS, Wong CP. Diabetes telemonitoring reduces the risk of hypoglycaemia during Ramadan: a pilot randomized controlled study. Diabet Med. 2015 Dec;32(12):1658-61. doi: 10.1111/dme.12836. Epub 2015 Jul 15.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MRFAST
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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