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OpenTrials
Completed

NCT Number: NCT06783907

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

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.

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Key information

Conditions

Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

LEI FOOK Neighbourhood Elderly Centre

Hong Kong

About this study

Research aim

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • aged ≥ 60 years old;
  • patients diagnosed with Type II DM without insulin injections;
  • patients experienced hypo (histix < 4.0 mmol/L) or hyperglycemia (histix
  • 16.0 mmol/L); &
  • The Abbreviated Mental Test (AMT) ≥ 6.

Exclusion criteria

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

Treatment and study plan

Non-invasive blood glucose monitoring

Behavioral

Non-invasive wearable glucose monitoring device for capturing participants' blood glucose.

The intervention will include:

  • Training for self-management of diabetes and phone consultation.
  • Follow-up through phone calls or WhatsApp for hypoglycaemic or hyperglycaemic events.
  • 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.

Traditional blood glucose monitoring

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. Change in lipid and glucose panel

    Time frame: 8 weeks

    Change in lipid and glucose panel measured by CardioChek

  2. Change in basic anthropometric measurement

    Time frame: 8 weeks

    Change in basic anthropometric measurement:

    • Height will be measured in meters using a tape measure.
    • Weight will be measured in kilograms using a scale.
    • Weight and height will be combined to report Body Mass Index (BMI) in kg/m^2

  3. Change in blood pressure

    Time frame: 8 weeks

    Change in blood pressure:

    Measured using Omron M7 blood pressure monitors to assess brachial blood pressure

  4. 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

  5. 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.

Sponsors and collaborators

Lead sponsor

Hong Kong Metropolitan University

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 20, 2025
Registry last updated
Sep 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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