A Randomized Trial to Slow the Progression of Diabetes
Condition: Diabetes Mellitus, Type 2
MeSH terms: Diabetes Mellitus; Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      The research objective of this one-year study is to test whether an evidence-based, low-cost
      mobile diabetes management package (DMP), with or without an incentive program grounded in
      economic theory (M-POWER Rewards), can effectively and cost-effectively improve health
      outcomes for adults with type 2 diabetes.
    

Detailed description: 
      Technological and economic advancement have created a major challenge to public health
      agencies in Singapore and other first world countries: the challenge being how to get
      individuals to maintain a healthy lifestyle when that is no longer a requirement for economic
      prosperity (and in fact may be a hindrance). What is required is a low cost strategy that
      effectively manages risk factors for chronic disease without overwhelming the public
      healthcare infrastructure. Although technology and economic advancement are clearly part of
      the problem, they may also be part of the solution.

      For patients with type 2 diabetes mellitus (T2DM), lifestyle modification can be highly
      effective at stemming the progression of the disease. Effective interventions include modules
      that teach appropriate strategies for weight management, increased physical activity, better
      diet, routine glucose monitoring, and strict compliance to prescribed diabetes medications.
      These components can now be effectively delivered electronically. A recent review and
      meta-analysis of 13 smartphone applications for diabetes management found that these
      applications offered modest benefits, with a mean difference in HbA1c of -0.40%.

      Because of the high costs involved in treating people with chronic conditions, employers,
      insurers, and governments all have a financial incentive to contain the chronic disease
      epidemic. Therefore, each has shown a willingness to invest in some level of prevention and
      treatment efforts. It is our contention that contingent rewards may be necessary to help
      people overcome their preferences for current over future consumption, often called present
      bias. Behavioral economists recommend that, to overcome present bias, rewards should be tied
      to both short-term and long-term outcomes or behaviors, such as monitoring blood glucose and
      taking medications as prescribed (short term) and pre-defined outcomes such as achieving a
      target HbA1c level over a specified duration (long term). Based on a recent systematic review
      of incentive studies conducted by members of our team, an optimal rewards strategy has the
      potential to greatly increase the effectiveness of existing mobile diabetes applications. If
      shown to be effective and cost effective, the investigators also believe payers will
      subsidize such a strategy.

      Specifically, the investigators propose to conduct a 52-week, three-arm randomized controlled
      trial to evaluate whether an evidence-based, low-cost mobile diabetes management package
      (DMP), with or without an incentive program grounded in economic theory, can effectively and
      cost-effectively improve outcomes for adults with diabetes. The control arm (Arm 1) will
      receive usual care, whereas participants in the intervention arms will receive the DMP alone
      (Arm 2) or the DMP with the M-POWER Rewards incentive program (Arm 3) in addition to their
      usual care. The investigators hypothesize that participants in Arms 2 and 3 will show
      improved glycemic control, as measured by HbA1c levels, at the Month 12 primary endpoint
      compared to participants in the Arm 1 control group. The investigators also hypothesize that
      Arm 3 will have improved HbA1c levels compared to Arm 2 at Month 12. Similar hypotheses will
      be tested for secondary outcomes measured at Month 6.

      In addition, the investigators will quantify the incremental cost-effectiveness of DMP with
      M-POWER Rewards and the net cost implications of both from a third party payer's perspective.
      The investigators hypothesize that despite its higher implementation cost, effectiveness will
      be greater and net cost will be lower for Arm 3 relative to the Arm 1 control group due to
      the reduction in medical expenditures that result from improved glycaemic control.
    

Intervention name(s): Diabetes Management Package (DMP); M-POWER Rewards
Intervention type(s): Behavioral; Behavioral
Intervention description(s): M-POWER app: A one-stop portal to monitor diabetes self-management activities and progress. The app syncs and displays relevant data from study devices and apps.
GlycoLeap: A 24-week, digitally-delivered education and behavior change program for T2DM patients.
4 study devices with accompanying apps to aid in diabetes self-management: weighing scale, pedometer, glucometer, and pill tracker.
Recommended activities:
Complete all 24 GlycoLeap lessons and quizzes
Weight Monitoring: Weigh at least once a week.
Physical Activity: At least 150 minutes of moderate-to-vigorous activity per week, targeting at least 420 Fitbit active minutes per week.
Blood Glucose Monitoring: At least three post-meal measurements within 4.0-10.0 mmol/L per week, with each reading taken on different days.
Medication: Take medications as prescribed.; A financial incentive program were participants can earn up to 516 M-Points (1 M-Point is equivalent to S$1) over the one-year study period for performing specific activities according to recommendations that are meant to improve glycemic control and for achieving HbA1c and weight loss goals. M-Points can be reimbursed in the form of financial rebates for approved non-inpatient healthcare-related expenses incurred during the study period.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Diabetes; Smartphone application; Behavior change; Weight monitoring; Physical activity; Blood glucose monitoring; Medication adherence; Financial incentive; Cost-effectiveness analysis