Better Risk Perception Via Patient Similarity to Control Hyperglycemia and Sustained by Telemonitoring

Background: Diabetes significantly raises the likelihood of complications, thereby increasing the risk of diabetes-related mortality, particularly due to vascular complications. It is vital to address this rising trend of mortality, by enhancing awareness of diabetes complications to improve risk perception and ultimately reduce mortality rates. Managing diabetes effectively requires interventions addressing both risk communication and monitoring, helping patients better understand and make informed decisions about their health. Objectives: The primary aim is to evaluate and compare the effectiveness of combined risk communication session using an AI module (PERDICT.AI) and home-based diabetes monitoring (PTEC-DM) versus a standalone risk communication session in improving health outcomes (risk perception, medication adherence, self-care activities and glycaemic control) among poorly controlled diabetes patients. Secondary aims are to explore participants' views and experiences of risk communication session using PERDICT.AI, PTEC-DM and usual care and clinician' views on utility of the new approach to improve risk perception. Methods: A mixed-method study design will be employed to conduct a multi-arm randomized controlled trial across four of the SingHealth Polyclinics cluster (Pasir Ris, Eunos, Sengkang, Tampines North). Patient participants will be randomly allocated in a 1:1:1 ratio to one of the three arms. Arm 1 will receive risk communication session using PERDICT.AI and home-based diabetes monitoring using PTEC-DM alongside usual care. Arm 2 participants will undergo a standalone risk communication session using PERDICT.AI with usual care while arm 3 will serve as the control group with usual care. A total of 360 (120 in each group) participants will be enrolled by simple randomization. Eligible patient must be of age between 36 and 65 years with HbA1c \>8.0% within the last 6 months. Significance of the study: Findings from the study may add evidence to the scientific knowledge of using these approaches to improve risk perception and recommend development of similar interventions.

NCT Number	NCT06607497
Lead Sponsor	SingHealth Polyclinics Collaborators: AISG Health Grand Challenge
Conditions	Diabetes Mellitus, Type 2
Enrollment	360 participants
Start Date	2024-07-15
Primary Completion	2026-12-31 (estimated)
Study Completion	2026-12-31 (estimated)
Updated on ClinicalTrials.gov	2026-05-12