CompletedNot Applicable

Intervention for Diabetes With Education, Advancement and Support

Malaysia240 participantsStarted 2015-04

Plain-language summary

This study aims to evaluate a culturally appropriate, low cost and sustainable management plan for patients with type 2 diabetes mellitus (T2DM). Various randomized controlled trials confirmed that T2DM can be delayed with lifestyle intervention and programmes which promote improvements in diet, increased physical activity and weight loss. Translation of lifestyle intervention to real-life settings however remains a major challenge. The investigators therefore propose a diabetes management trial for T2DM patients using telemedicine. This project's innovations include the use of information technology to deliver messages to the physicians while similarly involving family members of diabetics to manage the patient's condition collectively. This creates a sense of well-being, empowering the individual as well as the community to be responsible for their own health and well-being

Who can participate

Age range

18 Years – 75 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Type 2 diabetes diagnosed by a physician at least six months prior to study enrollment * HbA1c of \> 7.5% but less than 11.0% within the most recent 3 months * Access to internet and an e-mail address , or access to a smartphone with 3G services * Not pregnant or history of heart diseases, serious illness, cancer diagnosis or any other conditions that can impede participation Exclusion Criteria: * Unable or unwilling to give informed consent or communicate with local study staff * Current diagnosis of schizophrenia, other psychotic disorders, or bipolar disorder * Hospitalization for depression in past six months * Plans to relocate to an area or travel plans that do not permit full participation in the study * Lack of support from primary health care provider or family members * History of bariatric surgery, small bowel resection, or extensive bowel resection * Currently pregnant or nursing * Cancer: requiring treatment in the past five years, except for non-melanoma skin cancers or cancers that have clearly been cured or in the opinion of the investigator carry an excellent prognosis (e.g., Stage 1 cervical cancer) * Cardiovascular disease (heart attack or procedure within the past three months or participation in a cardiac rehabilitation program within last three months, stroke or history/treatment for transient ischemic attacks in the past three months, or documented history of pulmonary embolus in past six months) * Other medical, psychiatric, or…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change in Hemoglobin A1c

Timeframe: 3 months, 6 months, 12 months

Trial details

NCT IDNCT02466880

SponsorMonash University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-02-28

View on ClinicalTrials.gov More Diabetes Mellitus trials