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

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus

• Registration Number: NCT06783907
• Lead Sponsor: Hong Kong Metropolitan University

Brief 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.

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 Timeline

• Study Start: 2023-12-01
• Study First Submitted: 2024-12-12
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-16
• Last Update Submitted: 2025-01-16
• Study First Posted: 2025-01-20
• Last Update Posted: 2025-01-20
• Primary Completion: 2025-02-28
• Study Completion: 2025-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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); &

4. 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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The point of care test (POCT) of HbA1C level	8 weeks	Change in HbA1C level The HbA1C will be measured by A1CNow system.

Secondary Outcome Measures

Name	Time	Method
Change in lipid and glucose panel	8 weeks	Change in lipid and glucose panel measured by CardioChek
Change in basic anthropometric measurement	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
Change in blood pressure	8 weeks	Change in blood pressure: Measured using Omron M7 blood pressure monitors to assess brachial blood pressure
Change in breath and blood ketone	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
Change in Summary of Diabetes Self-Care Activities (SDSCA) Chinese Version	8 weeks	Change in Summary of Diabetes Self-Care Activities (SDSCA) Chinese Version: Used to assess participants' diabetes self-care activities.

Trial Locations

Locations (1)

LEI FOOK Neighbourhood Elderly Centre; 🇭🇰 Hong Kong, Hong Kong