Clinical trial NCT04832984: Prevention and Treatment of Diabetes in Adults
Official title: Addressing Disparity in Diabetes Prevention Through Digital Health Supported PRe-diabetes Intervention, Management and Evaluation (PRIME) Program Based in Malaysian Community Pharmacies
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: PreDiabetes
Keywords: digital health
mobile health
lifestyle program
Lead sponsor: Monash University
Sponsor class: OTHER
Collaborators: name: Caring Pharmacy
name: Bionime Corporation
name: Tigas Pharma
First posted: 2021-04-06
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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

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

Primary outcomes:
measure: Change in body weight
timeFrame: Baseline, 1 month, 3 months, 6 months, 12 months
Secondary outcomes:
measure: Incidence of diabetes
timeFrame: 12 months
measure: Change in hemoglobin A1c
timeFrame: Baseline, 3 months, 6 months, 12 months
measure: Change in health related quality of life
timeFrame: Baseline, 1 month, 3 months, 6 months, 12 months
measure: Change in dietary practice
timeFrame: Baseline, 1 month, 3 months, 6 months, 12 months
measure: Change in physical activity
timeFrame: Baseline, 1 month, 3 months, 6 months, 12 months
measure: Change in cardiovascular risks
timeFrame: Baseline, 1 month, 3 months, 6 months, 12 months
measure: Change in anthropometry measures
timeFrame: Baseline, 1 month, 3 months, 6 months, 12 months
Other outcomes:
Locations:
city: Subang Jaya
country: Malaysia
facility: Shaun Lee
state: Selangor
Study officials:
affiliation: Monash University Malaysia
name: Shaun Lee
role: PRINCIPAL_INVESTIGATOR
affiliation: Monash University Malaysia
name: Chun Wie Chong
role: PRINCIPAL_INVESTIGATOR
References: