NCT00727896

Brief Summary

Type 2 diabetes is a chronic metabolic disorder requiring lifestyle modification and medicines, adherence to which has to be practised on a daily basis. Motivation of patients to adhere to treatment is difficult in clinical practice. It is well documented that majority of patients do not reach the glycaemic targets even in the centres of excellence. Regular short service messages (SMS) through cell phones could have a positive effect on behaviour and adherence to life style changes and compliance to drugs. It may be practical and feasible to use information technology as an effective and simple tool for motivating patients to adhere to the prescribed treatment regimen. In diabetic patients, frequent reminders regarding the need for adherence to LSM and drugs by the medical professionals will improve the compliance.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for phase_1 type-2-diabetes

Timeline
Completed

Started Aug 2008

Longer than P75 for phase_1 type-2-diabetes

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 31, 2008

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2008

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 4, 2008

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

June 27, 2011

Status Verified

March 1, 2011

Enrollment Period

1.7 years

First QC Date

July 31, 2008

Last Update Submit

June 24, 2011

Conditions

Type 2 Diabetes

Keywords

Life style modification,Type 2 diabetes,SMS,Patient adherence

Outcome Measures

Primary Outcomes (1)

  • Behavioural changes resulting in diet, better adherence to treatment.

    At intervals of three months for one year

Secondary Outcomes (1)

  • Reduction in HbA1c, other glycemic measures and improvement in blood lipid parameters

    Annual

Study Arms (2)

1 is experimental with SMS

EXPERIMENTAL

Arm 1 is experimental with SMS intervention

Behavioral: Pre-coded messages

2 is (active comparator) standard care

ACTIVE COMPARATOR

Arm 2 is the usual care arm (standard care)

Drug: Diabetes Treatment

Interventions

Pre-coded messagesBEHAVIORAL

Earlier life style modification and existing drug therapy was used and now SMS is added as a tool for reminder

1 is experimental with SMS
Diabetes TreatmentDRUG

Life style modification and drug therapy

2 is (active comparator) standard care

Eligibility Criteria

Age30 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male or female, 30-65 yrs of age at the time of entry and have type 2 diabetes for a minimum period of 5 years.
  • HbA1C ranging 8.0-10.0%
  • Patients either receiving OHA and / or insulin

You may not qualify if:

  • Type 1 diabetes
  • Patients with history of blindness, decreased vision
  • Serious vascular complications :
  • Cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Chennai, Tamil Nadu, 600 008, India

Location

Related 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(2):289-97. doi: 10.1007/s00125-005-0097-z. Epub 2006 Jan 4.

    PMID: 16391903BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2Patient Compliance

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesPatient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Officials

  • Samith A Shetty, M.B.B.S, MDRC

    India Diabetes Research Foundation (IDRF) and Dr.A.Ramachandran's Diabetes Hospitals

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 31, 2008

First Posted

August 4, 2008

Study Start

August 1, 2008

Primary Completion

April 1, 2010

Study Completion

April 1, 2010

Last Updated

June 27, 2011

Record last verified: 2011-03

Locations

IN(1)