Making Ramadhan Fasting a Safer Experience With Technology Study

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Monash University
Sponsor:
Collaborator:
SEGi University
Information provided by (Responsible Party):
Shaun Lee Wen Huey, Monash University
ClinicalTrials.gov Identifier:
NCT02189135
First received: July 9, 2014
Last updated: July 15, 2014
Last verified: July 2014
  Purpose

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 patients ever meet their HbA1c goal. In most patients with type 2 diabetes, the use of oral anti-diabetics is a mainstay in therapy. However, there is a risk of hypoglycaemia in most patients taking these drugs. This is especially important in T2DM Muslims wishing to fast during Ramadan as the dietary pattern changes to one large meal at sunset called 'Iftaar' and a light meal before dawn called 'Sahur'. Most Muslims will generally consume large quantities of fried and sugary foods when they break their fast or during the night. Given the importance and public health significance of poor diabetes management and its associated risk especially during Ramadan, the investigators aim to test the intervention of using remote monitoring within community provider practice for patients with T2DM. The investigators hypothesize that the combined use of a mobile enable glucometer which can directly feedback the patients glycaemic levels to the physicians will reduce and even eliminate the occurance of hypoglycaemia whilst ensuring that patients remain euglycaemic throughout the whole Ramadan month.


Condition Intervention Phase
Diabetes Mellitus, Non-Insulin-Dependent
Device: Telemedicine
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Making Ramadhan Fasting a Safer Experience With Technology Study

Resource links provided by NLM:


Further study details as provided by Monash University:

Primary Outcome Measures:
  • Mean change in serum fructosamineChange in fructosamine from start of Ramadan (day -1) to end of Ramadan (day 29). [ Time Frame: 30 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Glycaemic control of patients under usual care versus telemedicine from baseline to end of treatment (4 weeks) [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Hypoglycaemic rates in patients under usual care versus telemedicine from baseline to end of treatment (4 weeks) [ Time Frame: 30 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: July 2014
Estimated Study Completion Date: November 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual care
Usual care from physician/ doctor
Experimental: Telemedicine
Mobile wireless glucometer with feedback from physicians
Device: Telemedicine
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 Name: Myglucohealth wireless bluetooth glucometer

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 gycaemic 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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02189135

Contacts
Contact: Jun Yang Lee, MPharm lee.jun.yang@monash.edu

Locations
Malaysia
Klinik Kesihatan Pandamaran Recruiting
Klang, Selangor, Malaysia, 42000
Contact: Lee Jun Yang, MPharm         
Principal Investigator: Nazrila Nasir, MBBS         
Sponsors and Collaborators
Monash University
SEGi University
Investigators
Principal Investigator: Shaun Lee, PhD Monash University
  More Information

No publications provided

Responsible Party: Shaun Lee Wen Huey, Shaun Lee, Monash University
ClinicalTrials.gov Identifier: NCT02189135     History of Changes
Other Study ID Numbers: MRFAST
Study First Received: July 9, 2014
Last Updated: July 15, 2014
Health Authority: Malaysia: Ministry of Health
Malaysia: National Medical Research Register

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on September 16, 2014