Making Ramadhan Fasting a Safer Experience With Technology Study
Condition: Diabetes Mellitus, Non-Insulin-Dependent
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional
Phase: Phase 4

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 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 occurrence of hypoglycaemia whilst ensuring that patients remain
      euglycaemic throughout the whole Ramadan month.
    

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.
    

Intervention name(s): Telemedicine
Intervention type(s): Device
Intervention description(s): 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 intervention name(s): Myglucohealth wireless bluetooth glucometer
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment