Prevention and Treatment of Diabetes in Adults

NCT ID: NCT04832984

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 91 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-03-23
• Study Completion Date: 2024-06-30

Brief Summary

Currently, an estimated 3.9 million Malaysians continue to live with diabetes with many more who live with prediabetes. Diabetes was the one of the leading causes of death in the Malaysia and the leading cause for kidney failure, lower-limb amputations, and adult-onset blindness. Heart disease and stroke are two to four times more likely for individuals with diabetes. The use of mHealth or mobile health application can reduce blood sugar among individuals with prediabetes but also prevent a later occurrence of diabetes. In this study, the investigators aim to develop and evaluate the effectiveness of a digital health supported pre-diabetes management program based in an urban community pharmacy setting

Detailed Description

Pre-diabetes is an intermediate state of hyperglycaemia with glycaemic parameters above normal but below the type 2 diabetes mellitus (T2DM) threshold. It was estimated that >25% of individuals who are pre-diabetic convert to T2DM within 3-5 years and 70% of individuals with pre-diabetes will develop into full-fledge T2DM within their lifetimes. According to the 2017 estimate, the disease burden of pre-diabetes at Western Pacific region was 7.6% (126.7 millions). The situation is more alarming in Malaysia where a national pre-diabetes prevalence of 22.1% was noted. Currently available support and self-care services offered in Public Hospitals such as the Diabetes Mellitus Treatment Adherence Clinics (DMTAC) are managed based on the in-person appointment basis. Most of the clinics are available only in specific locations. The need to travel long distance as well as long waiting hours has deterred the success of the programs. This is particularly true for the urban poor who are less likely to take time off from work than those from the higher income group. It is also noteworthy to state that the management program when available, generally target the diagnosed T2DM patients.

Studies have shown that individuals with pre-diabetes can substantially reduce their risk of progression to T2DM via participation in evidence-based lifestyle change programs. Previous reports have recorded 54-58% reduction in risk for development to T2DM over 1-3 years with the protective benefit persisting up to 10 years following completion of the program. However, there are several considerations when implementing effective lifestyle intervention program among the pre-diabetes populations in Malaysia. The intervention program should easily be accessible and not confined to public primary and secondary healthcare centres which are already suffering from an overcapacity. Furthermore, consultation should be provided by properly trained healthcare professionals while the ease of communication between the patients and the "lifestyle coach" should be made available.

The advancement of information technology coupled with the increasing availability and acceptance of internet and mobile devices provide useful opportunities for application of wireless and mobile technology in order to enhance self-management of chronic conditions. The incorporation of digital technologies can improve patient adherence and facilitate real-time monitoring of vital biological measurements (i.e. via wearable). Additionally, the "mobile health" (mHealth) services are easily scalable, thus providing opportunities to a greater public accessibility and narrow the disparity in access to disease management. In this study, the investigators propose to pilot a digital health supported pre-diabetes management program based in an urban community pharmacy setting

Conditions

PreDiabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Intervention arm

Participants receiving the phone app together with a fitness tracker. All participants will receive the educational curriculum through the app over a period of 24 weeks. The mobile app allows secure patient monitoring through a participant dashboard that the coach can use to increase patient adherence and motivation to achieve goals. The participants can use the app to log their food intake, weight, steps, exercise, in addition to participating in the peer support via the chat function. Participants will also receive regular care and follow up in community pharmacies for support.

Group Type: EXPERIMENTAL

Mobile health

Intervention Type: BEHAVIORAL

Participants will be issued a fitness tracker, Bluetooth enabled glucometer, and a custom developed app which they can communicate digitally to the study investigators either as a group or individually. In the beginning of the study, participants will be taught on how to use the program, how to interact with their coach, and the importance of maintaining motivation throughout the program. Participants will have access to a pharmacist-participant messaging, group messaging, daily challenges for behavior change, education articles (biweekly bite-sized content over 24 weeks), food logging, steps and exercise logging, and feedback. They will be asked to log their weight, meals, and physical activity within the program on a weekly basis. Pharmacist will monitor participant progress through a web-based dashboard. Community pharmacist will be assisting users in setting specific, measurable, attainable, realistic, and time-based goals on a weekly basis.

Usual care arm

The control group will be a "usual care" condition in which participants are free to seek any assistance for their medical care during the study period. Participants will be given physical tracking sheets to record their food intake, weight, steps and exercises.

Group Type: ACTIVE_COMPARATOR

Usual care

Intervention Type: BEHAVIORAL

Participants will be issued a fitness tracker and Bluetooth enabled glucometer but these functions will not be enabled or linked to any app. All participants will be given physical tracking sheets to log in their food intake, blood glucose levels and food diary but will not have access to a personal coaching. Participants are free to seek any assistance for their medical care during the study period.

Interventions

Mobile health

Participants will be issued a fitness tracker, Bluetooth enabled glucometer, and a custom developed app which they can communicate digitally to the study investigators either as a group or individually. In the beginning of the study, participants will be taught on how to use the program, how to interact with their coach, and the importance of maintaining motivation throughout the program. Participants will have access to a pharmacist-participant messaging, group messaging, daily challenges for behavior change, education articles (biweekly bite-sized content over 24 weeks), food logging, steps and exercise logging, and feedback. They will be asked to log their weight, meals, and physical activity within the program on a weekly basis. Pharmacist will monitor participant progress through a web-based dashboard. Community pharmacist will be assisting users in setting specific, measurable, attainable, realistic, and time-based goals on a weekly basis.

Intervention Type: BEHAVIORAL

Usual care

Participants will be issued a fitness tracker and Bluetooth enabled glucometer but these functions will not be enabled or linked to any app. All participants will be given physical tracking sheets to log in their food intake, blood glucose levels and food diary but will not have access to a personal coaching. Participants are free to seek any assistance for their medical care during the study period.

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Aged 18 years and above
• BMI 23 and above
• HbA1c 5.7 - 6.4% or FPG 5.6mmol/L - 6.9mmol/L

Exclusion Criteria

• Unable to give informed consent
• Pregnant or lactating
• Established diabetes
• Terminal illness
• Does not own a mobile phone
• Plans to relocate to an area or travel plans that do not permit full participation in the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Caring Pharmacy

UNKNOWN

Sponsor Role: collaborator

Bionime Corporation

INDUSTRY

Sponsor Role: collaborator

Tigas Pharma

UNKNOWN

Sponsor Role: collaborator

Monash University

OTHER

Sponsor Role: lead

Responsible Party

Shaun Lee Wen Huey

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Shaun Lee

Role: PRINCIPAL_INVESTIGATOR

Monash University Malaysia

Chun Wie Chong

Role: PRINCIPAL_INVESTIGATOR

Monash University Malaysia

Locations

Shaun Lee

Subang Jaya, Selangor, Malaysia

Countries

Malaysia

References

Teoh KW, Ng CM, Chong CW, Cheong WL, Ng YL, Bell JS, Lee SWH. A digital health-supported and community pharmacy-based lifestyle intervention program for adults with pre-diabetes: a study protocol for a cluster randomised controlled trial. BMJ Open. 2024 Oct 23;14(10):e083921. doi: 10.1136/bmjopen-2024-083921.

Reference Type: DERIVED

PMID: 39448216 (View on PubMed)

Other Identifiers

PRIME

Identifier Type: -

Identifier Source: org_study_id