Use of Information Technology in the Prevention of Diabetes

February 13, 2013 updated by: Dr.A.Ramachandran, India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals

The Role of Information Technology in the Primary Prevention of Type 2 Diabetes

Type 2 diabetes is a major and increasing problem in India and the UK. In clinical trials it can be prevented in people at high risk by lifestyle intervention. While these trials established the proof of principle, they involved a degree of input from healthcare professionals not feasible outside the trial situation. We hypothesize that diabetes prevention can be achieved at lower cost using personalised feedback via mobile phone, based on information on healthy diet and physical activity habits. We shall develop research protocols and computerized algorithms to test this hypothesis in India for application subsequently in the UK and elsewhere.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Diabetes prevention programmes conducted in various ethnic and racial populations have conclusively demonstrated that lifestyle modification (LSM) focussed on caloric restriction and increased physical activity can prevent or postpone the onset of T2DM. The Indian Diabetes Prevention Programme-1 (IDPP-1) conducted by our group established that LSM is an effective tool for the primary prevention of T2DM in Asian Indian subjects (1). But the major hurdle for any clinical trial is to disseminate the intervention principles at a community level is often proved to be very difficult. The main objective of this prevention programme is to determine whether individualized messages on LSM (diet and physical activity) by mobile phone-based message delivery system can help educate and motivate subjects with a high risk for developing type 2 diabetes to adhere to LSM and thereby improve glucose tolerance.

Sample selection:

This is a randomized, controlled prospective study, carried out in participants who have been diagnosed with persistent IGT using the 1999 World Health Organization (WHO) criteria. Interested participants who fulfilled the inclusion criteria participated in this prevention programme. Screening was carried out in the work places. The participants were advised not to do any strenuous work during the screening period. Interested participants, after an overnight fast of 8 to 12 hours, underwent a capillary blood glucose test 2h PG after an ingestion of 75G glucose. Among the subjects identified with IGT, those with 2h PG values >8.9 mmol/l (≥ 160 mg/dl) were invited for a confirmatory OGTT, within a week. During the 2nd GTT, venous blood samples were collected at fasting (0 minute), 30 and 120 minutes after the glucose intake.Subjects who satisfied the criteria for IGT on both occasions were recruited for this prevention programme. Randomized was based on the MATLAB 'randperm' random number generator (MARSAGLIA RANDOM NUMBER generator algorithm).

Recruitment:

Subjects were recruited into two groups:

  1. control arm: advised on LSM and the beneficial effects of healthy dietary habits, weight reduction and increased physical activity at the baseline, 6, 12, 18 and 24 months respectively (standard care advise).
  2. Intervention group: receive in addition to the above advise would receive frequent text messages on general well being and different forms of physical activity and principles of healthy diet. The frequency and time at which each participant preferred to receive the messages were noted.

Assessments:

Both groups will undergo personal reviews at 6 monthly intervals for a period of 2 years. At randomization, participants were interviewed personally to elicit demographic, medical, diet, behavioral and physical activity details.

6 & 18 month assessments: Diet and physical activity questionnaires, body weight, WC, pulse and BP will be obtained. Two hour post glucose will be measured.

12 & 24 month assessment: Participants will be questioned about the acceptability of the project and its impact on their life. Changes in health will be documented and the physical examination repeated. They will complete further dietary, physical activity and quality of life questionnaires and will be asked about their use of healthcare resources for health economic assessment. The OGTT and ECG will be repeated, with other measurements as at baseline.

Study Type

Interventional

Enrollment (Actual)

537

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • TamilNadu
      • Chennai, TamilNadu, India, 600 008
        • Dr.Ambady Ramachandran

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 55 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Body mass index ≥ 23
  • Age ≥ 35 years
  • A 1st degree relative with type 2 diabetes

Exclusion Criteria:

  • Normal and diabetic subjects
  • Presence of other serious illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 2
In person lifestyle advice at baseline, 6, 12, 18 months.
Behavioral: Control arm (usual care/standard care arm)
Life style modification only once
Experimental: 1
In person lifestyle advice at baseline, 6, 12, 18 months. Receive reminders by internet based, mobile phone text messaging (Frequency, time and number(s) of messages according to participants requirement)
Behavioral: Experimental
Active Life style modification-motivation by I.T technology

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression to diabetes
Time Frame: 6 monthly intervals for 2 years
Prevention of type 2 diabetes in high-risk subjects by lifestyle modification
6 monthly intervals for 2 years

Secondary Outcome Measures

Outcome Measure
Time Frame
Improvement in metabolic risk factors for diabetes and cardiovascular diseases and improvement in quality of life
Time Frame: two years
two years
Acceptability of text messaging as tool to prevent diabetes.
Time Frame: Two years
Two years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Collaborators

Imperial College London

Investigators

  • Principal Investigator: Ambady Ramachandran, M.D, D.Sc, President, India Diabetes Research Foundation and Chairman & Managing Director, Dr.A.Ramachandran's Diabetes Hospitals
  • Principal Investigator: Desmond Geoffrey Johnston, MB Ch B, Ph.D, Professor of Clinical Endocrinology, Imperial College, London

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

January 8, 2009

First Submitted That Met QC Criteria

January 8, 2009

First Posted (Estimate)

January 9, 2009

Study Record Updates

Last Update Posted (Estimate)

February 15, 2013

Last Update Submitted That Met QC Criteria

February 13, 2013

Last Verified

February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IT001IDRF-IC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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