Use of Information Technology in the Prevention of Diabetes

Type 2 Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00819455
• Other study ID #: IT001IDRF-IC
• Status: Completed
• Phase: N/A
• First received: January 8, 2009
• Last updated: February 13, 2013
• Start date: March 2009
• Est. completion date: November 2012

Study information

• Verified date: February 2013
• Source: India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: India: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 537
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 35 Years to 55 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

Intervention

Behavioral:
• Experimental
Active Life style modification-motivation by I.T technology
• Control arm (usual care/standard care arm)
Life style modification only once

Locations

Country	Name	City	State
India	Dr.Ambady Ramachandran	Chennai	TamilNadu

Sponsors (2)

Lead Sponsor	Collaborator
India Diabetes Research Foundation & Dr. A. Ramachandran's Diabetes Hospitals	Imperial College London

Country where clinical trial is conducted

India, 

References & Publications (1)

Ramachandran A, Snehalatha C, Mary S, Mukesh B, Bhaskar AD, Vijay V; Indian Diabetes Prevention Programme (IDPP). The Indian Diabetes Prevention Programme shows that lifestyle modification and metformin prevent type 2 diabetes in Asian Indian subjects with impaired glucose tolerance (IDPP-1). Diabetologia. 2006 Feb;49:289-97. PMID: 16391903 Snehalatha C, Mary S, Joshi VV, Ramachandran A. Beneficial effects of strategies for primary prevention of diabetes on cardiovascular risk factors: results of the Indian Diabetes Prevention Programme. Diab Vasc Dis Res. 2008 Mar;5:25-9. PMID: 18398809 Murugesan N, Snehalatha C, Shobhana R, Roglic G, Ramachandran A. Awareness about diabetes and its complications in the general and diabetic population in a city in southern India. Diabetes Res Clin Pract. 2007 Sep;77:433-7. PMID: 17291622 Ramachandran A, Mary S, Yamuna A, Murugesan N, Snehalatha C. High prevalence of diabetes and cardiovascular risk factors associated with urbanization in India. Diabetes Care. 2008 May;31:893-8. PMID: 18310309 Ramachandran A. Epidemiology of diabetes in India--three decades of research. J Assoc Physicians India. 2005 Jan;53:34-8. Review. PMID: 15857011

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression to diabetes	Prevention of type 2 diabetes in high-risk subjects by lifestyle modification	6 monthly intervals for 2 years	Yes
Secondary	Improvement in metabolic risk factors for diabetes and cardiovascular diseases and improvement in quality of life		two years	Yes
Secondary	Acceptability of text messaging as tool to prevent diabetes.		Two years	No

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