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Technological-based Personalized Care Intervention for Supporting Older People With Diabetes Mellitus

NCT06783907 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-09-11

No results posted yet for this study

Summary

The objectives of this project are (1) to develop a new model of DM management using non-invasive healthcare technology for continuous glucose monitoring; (2) to use health apps to give timely personalized care intervention for enhancing compliance rate of DM self-management; \& (3) to compare the DM management using non-invasive healthcare technology to traditional invasive blood glucose monitoring method.

The proposed study will adopt a RCT with two treatment arms to clarify the effects of non-invasive blood glucose device on blood glucose monitoring. The two arms will be the non-invasive blood glucose monitoring (arm 1) and traditional self-monitoring (arm 2) as a control. A block randomisation and a single-blind design will be used. The inclusion criteria are (1) aged ≥ 60 years old; (2) patients diagnosed with Type II DM; (3) patients experienced hypo (histix \< 4.0 mmol/L) or hyperglycemia (histix ≥16.0 mmol/L); \& (iv) the Abbreviated Mental Test (AMT) ≥ 6.

Participants fitting the inclusion criteria will be selected by convenience sampling. They will join a two-arm RCT and will be allocated into the intervention or control group in a 1:1 ratio.

The primary outcomes will be the point of care test (POCT) of HbA1C level and the secondary outcomes will be the fasting blood glucose, total cholesterol, blood pressure, basic anthropometric measurement, breath and blood ketone and Diabetes Self-Care activities questionnaire. The outcome measurements will be recorded before the intervention (T0) and immediately after the 8-week intervention (T1).

The required sample size would be 30 participants per group (with a ratio of 1:1) for testing the feasibility of the study.

Conditions

Interventions

BEHAVIORAL

Non-invasive blood glucose monitoring

Non-invasive wearable glucose monitoring device for capturing participants' blood glucose. The intervention will include: 1. Training for self-management of diabetes and phone consultation. 2. Follow-up through phone calls or WhatsApp for hypoglycaemic or hyperglycaemic events. 3. Personalized care guided by sensor data. The Investigator will monitor the health data from the device regularly. A mobile app will track and record compliance with blood glucose monitoring.

BEHAVIORAL

Traditional blood glucose monitoring

Traditional blood glucose monitoring Participants will engage in traditional self-monitoring of blood glucose at home over the course of 8 weeks. They are recommended to check their blood glucose levels one to two times per week and record all results. This will allow for the collection of data using traditional monitoring methods.

Sponsors & Collaborators

  • Hong Kong Metropolitan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-12-01
Primary Completion
2025-06-10
Completion
2025-06-10

Countries

  • Hong Kong

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06783907 on ClinicalTrials.gov