Effectiveness of Automated Mobile Phone Based Text Messaging on the Improvement of Glycaemic Outcomes

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

BEHAVIORAL

Mobile phone text messaging

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.

OTHER

Conventional care

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).

Sponsors & Collaborators

• India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals

  lead OTHER

Principal Investigators

• Ambady Ramachandran, Prof · Chairman, India Diabetes Research Foundation

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

20 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2014-12-31

Primary Completion

2018-04-30

Completion

2018-12-31

Countries

• India

Study Locations