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

NCT06783907 | Completed

• 1 other identifier: HE-RD/2023/1.11
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus

Keywords

Non-invasive technology for continuous glucose monitoring; Diabetes Mellitus Self-management

Outcome Measures

Primary Outcomes (1)

• The point of care test (POCT) of HbA1C level

  Change in HbA1C level The HbA1C will be measured by A1CNow system.

  8 weeks

Secondary Outcomes (5)

• Change in lipid and glucose panel

  8 weeks

• Change in basic anthropometric measurement

  8 weeks

• Change in blood pressure

  8 weeks

• Change in breath and blood ketone

  8 weeks

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

  8 weeks

Study Arms (2)

Non invasive blood glucose monitoring group

EXPERIMENTAL

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

Traditional blood glucose monitoring

ACTIVE COMPARATOR

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

Interventions

Non-invasive blood glucose monitoring BEHAVIORAL

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.

Non invasive blood glucose monitoring group

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.

Traditional blood glucose monitoring

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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).

Sponsors & Collaborators

• Hong Kong Metropolitan University: lead

Study Sites (1)

LEI FOOK Neighbourhood Elderly Centre

Hong Kong, Hong Kong

Location

Related Publications (9)

• Saeedi P, Petersohn I, Salpea P, Malanda B, Karuranga S, Unwin N, Colagiuri S, Guariguata L, Motala AA, Ogurtsova K, Shaw JE, Bright D, Williams R; IDF Diabetes Atlas Committee. Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045: Results from the International Diabetes Federation Diabetes Atlas, 9th edition. Diabetes Res Clin Pract. 2019 Nov;157:107843. doi: 10.1016/j.diabres.2019.107843. Epub 2019 Sep 10.

  PMID: 31518657 BACKGROUND

• 2. World Health Organization. (2016). Global Report on Diabetes. In World Health Organization (Vol. 978). https://doi.org/ISBN 978 92 4 156525 7

  BACKGROUND

• 3. Centre for Health Protection. (2017). Report of Population Health Survey 2014/2015.

  BACKGROUND

• Wang L, Miller LC. Just-in-the-Moment Adaptive Interventions (JITAI): A Meta-Analytical Review. Health Commun. 2020 Nov;35(12):1531-1544. doi: 10.1080/10410236.2019.1652388. Epub 2019 Sep 5.

  PMID: 31488002 BACKGROUND

• Goldstein SP, Zhang F, Klasnja P, Hoover A, Wing RR, Thomas JG. Optimizing a Just-in-Time Adaptive Intervention to Improve Dietary Adherence in Behavioral Obesity Treatment: Protocol for a Microrandomized Trial. JMIR Res Protoc. 2021 Dec 6;10(12):e33568. doi: 10.2196/33568.

  PMID: 34874892 BACKGROUND

• Hardeman W, Houghton J, Lane K, Jones A, Naughton F. A systematic review of just-in-time adaptive interventions (JITAIs) to promote physical activity. Int J Behav Nutr Phys Act. 2019 Apr 3;16(1):31. doi: 10.1186/s12966-019-0792-7.

  PMID: 30943983 BACKGROUND

• Teepe GW, Da Fonseca A, Kleim B, Jacobson NC, Salamanca Sanabria A, Tudor Car L, Fleisch E, Kowatsch T. Just-in-Time Adaptive Mechanisms of Popular Mobile Apps for Individuals With Depression: Systematic App Search and Literature Review. J Med Internet Res. 2021 Sep 28;23(9):e29412. doi: 10.2196/29412.

  PMID: 34309569 BACKGROUND

• Perski O, Hebert ET, Naughton F, Hekler EB, Brown J, Businelle MS. Technology-mediated just-in-time adaptive interventions (JITAIs) to reduce harmful substance use: a systematic review. Addiction. 2022 May;117(5):1220-1241. doi: 10.1111/add.15687. Epub 2021 Oct 11.

  PMID: 34514668 BACKGROUND

• 9. Pimenta, N., Félix, I. B., Monteiro, D.

  BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 12, 2024
• First Posted: January 20, 2025
• Study Start: December 1, 2023
• Primary Completion: June 10, 2025
• Study Completion: June 10, 2025
• Last Updated: September 11, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

HK (1)