Effectiveness of Education, Medication Adjustment and Telemonitoring in Reducing Diabetes Complications During Ramadan
Condition: Diabetes Mellitus; Fasting; Diabetes Complications
MeSH terms: Diabetes Mellitus; Diabetes Complications
Study type: Interventional

Summary: 
      Introduction Diabetes is a global emergency with detrimental clinical and financial
      consequences. Poorly managed diabetes leads to a myriad of serious complications, especially
      cardiovascular and infectious complications, with consequent increased cost and mortality
      rate. For Muslims in particular, the annual fasting month of Ramadan is one such period when
      diabetes control is essential. Adequate adjustments in diabetes management need to be made in
      line with the allowed meal times to avoid the risk of diabetes complications during Ramadan.

      Objective Investigators aim to investigate the effectiveness of focused diabetes education
      and medication adjustment with telemonitoring to reduce diabetes complications during Ramadan
      fasting as well as to assess the cost-effectiveness of this intervention for Muslims with
      diabetes in Singapore.

      Methodology In a parallel group randomized controlled trial, investigators aim to recruit 100
      adults with diabetes who are able to fast at least 15 days in Ramadan. Participants will be
      randomized to the intervention group comprising of focused diabetes education, medication
      adjustment and telemonitoring, and control group receiving standard care. Participants will
      be followed up during Ramadan. The primary outcome is the incidence of hypoglycemia in
      Ramadan. The secondary outcomes are (i) incidence of other diabetes complications in Ramadan
      episodes including hyperglycemia, episodes of acute infections, attendances in clinic and
      emergency department and that of hospital admission, and (ii) cost-effectiveness of the
      intervention.

      Clinical Significance The study enables investigators to evaluate focused pre-Ramadan
      diabetes education and medication adjustment with tele-monitoring as a means to reduce the
      markedly increased risk of diabetes complications for a large population during the fasting
      month, with potential for increased cost-effectiveness through reducing unscheduled
      attendances at clinic and hospital.
    


Intervention name(s): Focused education, medication adjustment and telemonitoring
Intervention type(s): Combination Product
Intervention description(s): Focused diabetes education session for Ramadan fasting
Participants will be taught to record
Meal plans
Physical activities
Blood glucose monitoring, and
Monitoring for diabetes complications. Then perform a trial fasting day prior to Ramadan when control is not optimal or medication with risk of hypoglycemia.
Medication adjustment for Ramadan fasting Participants will be provided regimen modified for Ramadan fasting.
Telemonitoring
Participants will be taught to perform blood glucose monitoring 4 times daily using a glucometer and upload recordings of glucose levels onto the data software.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment