Prevention and Treatment of Diabetes in Adults

PreDiabetes Clinical Trial

Official title:

Addressing Disparity in Diabetes Prevention Through Digital Health Supported PRe-diabetes Intervention, Management and Evaluation (PRIME) Program Based in Malaysian Community Pharmacies

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04832984
• Other study ID #: PRIME
• Status: Active, not recruiting
• Phase: N/A
• Start date: March 23, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: March 2024
• Source: Monash University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 300
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• PreDiabetes
• Prediabetic State

Intervention

Behavioral:
• 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.
• 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.

Locations

Country	Name	City	State
Malaysia	Shaun Lee	Subang Jaya	Selangor

Sponsors (4)

Lead Sponsor	Collaborator
Monash University	Bionime Corporation, Caring Pharmacy, Tigas Pharma

Country where clinical trial is conducted

Malaysia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in body weight	Weight Loss by % of change and total weight change (kg)	Baseline, 1 month, 3 months, 6 months, 12 months
Secondary	Incidence of diabetes	Number of participants who develop diabetes after 12 months	12 months
Secondary	Change in hemoglobin A1c	Haemoglobin A1c measured during follow-up appointments	Baseline, 3 months, 6 months, 12 months
Secondary	Change in health related quality of life	EuroQol (EQ-5D-5L) to assess quality of life, with higher scores indicating better quality of life. Hospital Anxiety Depression Scale, Perceived Stress Scale and Brief Illness Perception Questionnaire to access mood and mental health.	Baseline, 1 month, 3 months, 6 months, 12 months
Secondary	Change in dietary practice	3-day diet recall to assess changes in food intake	Baseline, 1 month, 3 months, 6 months, 12 months
Secondary	Change in physical activity	Physical Activity Questionnaire (short form) (IPAQ) to obtain internationally comparable data on health-related physical activity	Baseline, 1 month, 3 months, 6 months, 12 months
Secondary	Change in cardiovascular risks	Blood pressure and lipid profile will be collected to assess cardiovascular risks.	Baseline, 1 month, 3 months, 6 months, 12 months
Secondary	Change in anthropometry measures	Body fat composition in % change, and change in waist-to-hip ratio.	Baseline, 1 month, 3 months, 6 months, 12 months