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

September 9, 2025 updated by: Dr Queenie Law Pui Sze, Hong Kong Metropolitan University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Research aim

1. This study will aim 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. 4. To improve self-management skills, decrease hospital admissions, and save medical.

Our DM project integrates personalized care intervention with a non-invasive continuous glucose monitoring (CGM) device for diabetes patients. The use of mHealth (Mobile health) ensures timely care without time or location constraints, while Just-in-Time Adaptive Intervention (JITAI) provides instant, personalized support. The painless, non-invasive CGM device offers an alternative to traditional finger-prick methods, improving compliance with self-management. This approach is particularly beneficial for patients who struggle with conventional monitoring and aims to enhance both patient outcomes and healthcare efficiency, especially for older people at high risk of hypo- or hyperglycemia.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • LEI FOOK Neighbourhood Elderly Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. aged ≥ 60 years old;
  2. patients diagnosed with Type II DM without insulin injections;

  3. patients experienced hypo (histix < 4.0 mmol/L) or hyperglycemia (histix

    • 16.0 mmol/L); &

2. The Abbreviated Mental Test (AMT) ≥ 6.

Exclusion Criteria:

  1. patient on dialysis;
  2. taking ascorbic acid > 500mg daily or (Not recommended by manufacturer as result may be affected);
  3. taking salicylic acid ≥ 650mg single dose or (Not recommended by manufacturer as result may be affected); or
  4. scheduled radiological therapy during CGM application (Not recommended by manufacturer as result may be affected).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Health Services Research
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Non invasive blood glucose monitoring group
Non invasive blood glucose monitoring : Participants will use a non-invasive sensor on the arm for blood glucose monitoring during the first and second weeks, as well as the seventh and eighth weeks. Between the third and sixth weeks, participants will be asked to monitor their blood glucose levels at home using traditional methods.
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.
Active Comparator: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The point of care test (POCT) of HbA1C level
Time Frame: 8 weeks
Change in HbA1C level The HbA1C will be measured by A1CNow system.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in lipid and glucose panel
Time Frame: 8 weeks
Change in lipid and glucose panel measured by CardioChek
8 weeks
Change in basic anthropometric measurement
Time Frame: 8 weeks

Change in basic anthropometric measurement:

  1. Height will be measured in meters using a tape measure.
  2. Weight will be measured in kilograms using a scale.
  3. Weight and height will be combined to report Body Mass Index (BMI) in kg/m^2
8 weeks
Change in blood pressure
Time Frame: 8 weeks

Change in blood pressure:

Measured using Omron M7 blood pressure monitors to assess brachial blood pressure
8 weeks
Change in breath and blood ketone
Time Frame: 8 weeks

Change in breath and blood ketone:

Used to detect ketones in the breath and blood, indicating hyperglycemia or diabetic ketoacidosis in individuals with diabetes
8 weeks
Change in Summary of Diabetes Self-Care Activities (SDSCA) Chinese Version
Time Frame: 8 weeks

Change in Summary of Diabetes Self-Care Activities (SDSCA) Chinese Version:

Used to assess participants' diabetes self-care activities.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hong Kong Metropolitan University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2023

Primary Completion (Actual)

June 10, 2025

Study Completion (Actual)

June 10, 2025

Study Registration Dates

First Submitted

December 12, 2024

First Submitted That Met QC Criteria

January 16, 2025

First Posted (Actual)

January 20, 2025

Study Record Updates

Last Update Posted (Estimated)

September 11, 2025

Last Update Submitted That Met QC Criteria

September 9, 2025

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE-RD/2023/1.11

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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