Effectiveness of Automated Mobile Phone Based Text Messaging on the Improvement of Glycaemic Outcomes
Condition: Type 2 Diabetes Mellitus
MeSH terms: Diabetes Mellitus, Type 2
Study type: Interventional

Summary: 
      In India, the high diabetes prevalence and cost of its management relative to their personal
      income render the country an appropriate environment to seek and test new, less expensive
      aids to care. Education and motivation to induce behavioural modification, are important
      components of care. Conventional diabetes education programmes involving personal contact
      methods are useful but expensive. Compliance with medications is also important and there are
      data to suggest that compliance is low in people with established type 2 diabetes (there is
      little information on those with recently diagnosed disease). Mobile phones could provide an
      inexpensive and scaleable delivery vehicle for components of care. There are now more than 5
      billion wireless subscribers and 70% of them live in low and middle income countries. Mobile
      phone ownership is high in India and an increasing proportion now has Mobile phones and/or
      home computers. The investigators plan a clinical trial in India to assess whether there is
      benefit from an enhanced text message intervention delivered by mobile phone in people newly
      diagnosed with Type 2 diabetes. The message content will be directed to behavioural
      modification, as with our diabetes prevention studies, and will attempt to improve compliance
      with drug therapy and other aspects of care, as with our studies in people with established
      diabetes. The investigators shall compare effects on glycaemia, other cardiovascular risk
      factors, lifestyle behaviour and quality of life, with those observed in people with type 2
      diabetes receiving standard care.
    

Detailed description: 
      India currently has 65 million people with type 2 diabetes and the number is increasing. In
      addition to its human costs, diabetes imposes a large economic burden. In those of average
      income in India, diabetes care consumes 25% of the family budget where one member is affected
      and proportionately more when there are other affected members (which is not uncommon); much
      of this expenditure is on medical and nursing costs aimed at achieving good glycaemic
      control. Diabetes management is important because it leads to better long-term clinical
      outcomes. The proof of principle trial - United Kingdom Prospective Diabetes Study (UKPDS) in
      patients with type 2 diabetes demonstrated that glycaemic control from the time of diagnosis
      produced beneficial effects during the trial and that these persisted for at least ten years
      afterwards (despite the confluence of HbA1c levels post-trial). There was continued
      improvement in microvascular complications and emergent significant reductions in myocardial
      infarction and death - the 'legacy effect'. Similar prolonged benefit has been demonstrated
      for Type 1 diabetes in the Diabetes Control and Complication Trial (DCCT) and its follow-up
      (for at least 17 years).

      Improving glycaemic control involves lifestyle modification (diet and physical activity),
      prompt introduction of hypoglycaemic therapy where necessary and then compliance with the
      treatment and monitoring. Dietary measures early after diagnosis lead to improved glycaemia
      and reductions in other cardiovascular risk factors. The importance of physical activity is
      often overlooked, but it contributes to maintenance of weight loss long-term, improves
      physical fitness and reduces cardiovascular risk factors. At or shortly after diagnosis,
      diabetes education aiming at lifestyle change is helpful in modifying behaviour and can
      reduce HbA1c. Although these programmes are effective, the benefits diminished over time e.g.
      the DESMOND programme resulted in improved HbA1c levels at twelve months but not at three
      years. There is evidence that the sustained benefit may be more likely if the educational
      programme is reinforced at a later stage. A major barrier to implementation of all education
      programmes, and particularly those which include reinforcement, is cost. Because they involve
      personal contact, the programmes are expensive and in reality, are offered to only small
      proportion of patients, even in developed countries. Although attempts have been made to
      utilise trained non-medical, non-nursing staff in education programmes in India, this model,
      while less expensive, has not been widely adopted. Attendance at educational sessions is also
      problematic, as it requires taking time off work or away from the family, or the venue is
      considered inaccessible.

      Text messaging (short message service, SMS) has the potential to overcome some of the
      difficulties. It is relatively cheap and potentially scalable. For example, in people with
      pre-diabetes in India the investigators have shown a 36% reduction in progression to diabetes
      over 2 years with text messaging-assisted behavioural modification. This reduction is similar
      to that achieved in India using personal contact methods. There are relatively few high
      quality studies on the role of text messaging or mobile phone contact as an aid to management
      of established Type 2 diabetes. In a pilot study in India, the investigators have
      demonstrated that text messaging can improve compliance with medications. A recent Cochrane
      review of IT-assisted methodologies for diabetes care and education suggested a small benefit
      for glycaemia, greatest where mobile phones (as opposed to home computers) were the delivery
      medium. The average lowering of HbA1c, as a result of mobile phone input on a range of
      studies was 5.5 mmol/mol (0.5%). This is clinically significant. Part of the reason for this
      benefit may reside in the nature of mobile phone contacts, being passive and, if
      appropriately designed, the message content can be encouraging rather than threatening in
      nature. The messages can also be sent repeatedly, with their frequency and timing dictated by
      the recipient.
    

Intervention name(s): Mobile phone text messaging; Conventional care
Intervention type(s): Behavioral; Other
Intervention description(s): The intervention will be text messages delivered by an automated text messaging manager. The message content will be designed to induce lifestyle modification (diet and physical activity) and will be motivational, based on the content which has been proven to be effective in reducing progression to diabetes in people with pre-diabetes. Other text messages will aim to improve drug compliance and disease monitoring, based on our pilot studies in India. The control arm will receive conventional management, according to local guidelines in the Indian centers, which in all cases are compatible with those of the International Diabetes Federation.; Conventional care is comprised of a one-to-one interview by a trained research personnel on diet and exercise advice at baseline and during every visit. The goals were to reduce portion size (total calories) and, to avoid simple sugars and refined carbohydrates, reduce total fat intake, restrict use of saturated fat, include more fibre rich food-(e.g., whole grains, legumes, vegetables, and fruits).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary purpose: Treatment