Diabetes MellitusNCT06783907
Technological-based Personalized Care Intervention for Supporting Older People With Diabetes Mellitus
A study testing Non-invasive blood glucose monitoring and Traditional blood glucose monitoring in people with Diabetes Mellitus, run by Hong Kong Metropolitan University at 1 site in Hong Kong.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Non-invasive blood glucose monitoring and Traditional blood glucose monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteHong Kong
- Study dates
- 1 Dec 2023to 10 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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); \&
- 2. The Abbreviated Mental Test (AMT) ≥ 6.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Diabetes Mellitus
- Being tested
- Non-invasive blood glucose monitoring, Traditional blood glucose monitoring
- Keywords
- Non-invasive technology for continuous glucose monitoring, Diabetes Mellitus Self-management
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-invasive blood glucose monitoringBehavioural
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 monitoringBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Traditional blood glucose monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
The point of care test (POCT) of HbA1C level
Change in HbA1C level The HbA1C will be measured by A1CNow system.
Measured: 8 weeks
Secondary outcomes (5)
Change in lipid and glucose panel
Change in lipid and glucose panel measured by CardioChek
Measured: 8 weeks
Change in basic anthropometric measurement
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
Measured: 8 weeks
Change in blood pressure
Change in blood pressure:
Measured using Omron M7 blood pressure monitors to assess brachial blood pressure
Measured: 8 weeks
Change in breath and blood ketone
Change in breath and blood ketone:
Used to detect ketones in the breath and blood, indicating hyperglycemia or diabetic ketoacidosis in individuals with diabetes
Measured: 8 weeks
Change in Summary of Diabetes Self-Care Activities (SDSCA) Chinese Version
Change in Summary of Diabetes Self-Care Activities (SDSCA) Chinese Version:
Used to assess participants' diabetes self-care activities.
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start1 Dec 2023
- Primary completion10 Jun 2025
- Study completion10 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hong Kong Metropolitan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Queenie Law Pui Sze, Hong Kong Metropolitan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783907
- Sponsor's protocol ID
- HE-RD/2023/1.11
- Status last verified
- Sep 2025
- First submitted
- 12 Dec 2024
- Last updated
- 11 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
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.
PubMed 315186572. World Health Organization. (2016). Global Report on Diabetes. In World Health Organization (Vol. 978). https://doi.org/ISBN 978 92 4 156525 7
3. Centre for Health Protection. (2017). Report of Population Health Survey 2014/2015.
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.
PubMed 31488002Goldstein 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.
PubMed 34874892Hardeman 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.
PubMed 30943983Teepe 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.
PubMed 34309569Perski 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.
PubMed 345146689. Pimenta, N., Félix, I. B., Monteiro, D.
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Technological-based Personalized Care Intervention for Supporting Older People With Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06783907
- Acronym / sponsor ID
- HE-RD/2023/1.11
- Conditions
- Diabetes Mellitus
- Keywords
- Non-invasive technology for continuous glucose monitoring, Diabetes Mellitus Self-management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Hong Kong Metropolitan UniversityUniversity, hospital or other
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 10 Jun 2025 (actual)
- Study completion
- 10 Jun 2025 (actual)
- First posted
- 20 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Non invasive blood glucose monitoring group | Experimental | Behavioral: Non-invasive blood glucose monitoringNon 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. |
| Traditional blood glucose monitoring | Active comparator | Behavioral: Traditional blood glucose monitoringTraditional 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- aged ≥ 60 years old;
- patients diagnosed with Type II DM without insulin injections;
- patients experienced hypo (histix < 4.0 mmol/L) or hyperglycemia (histix
- 2. The Abbreviated Mental Test (AMT) ≥ 6.
Key exclusion criteria (4 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-invasive blood glucose monitoringNon-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. | Behavioural | Non invasive blood glucose monitoring group |
| Traditional blood glucose monitoringTraditional 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. | Behavioural | Traditional blood glucose monitoring |
Primary outcome
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.
5 secondary outcomes
Change in lipid and glucose panel
Time frame: 8 weeks
Change in basic anthropometric measurement
Time frame: 8 weeks
Change in blood pressure
Time frame: 8 weeks
Change in breath and blood ketone
Time frame: 8 weeks
Change in Summary of Diabetes Self-Care Activities (SDSCA) Chinese Version
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2025.
- Background: PubMed 31518657Saeedi 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.
- Background2. World Health Organization. (2016). Global Report on Diabetes. In World Health Organization (Vol. 978). https://doi.org/ISBN 978 92 4 156525 7
- Background3. Centre for Health Protection. (2017). Report of Population Health Survey 2014/2015.
- Background: PubMed 31488002Wang 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.
- Background: PubMed 34874892Goldstein 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.
- Background: PubMed 30943983Hardeman 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.
- Background: PubMed 34309569Teepe 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.
- Background: PubMed 34514668Perski 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.
- Background9. Pimenta, N., Félix, I. B., Monteiro, D.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-invasive blood glucose monitoring and Traditional blood glucose monitoring in people with Diabetes Mellitus, run by Hong Kong Metropolitan University at 1 site in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The point of care test (POCT) of HbA1C level (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06783907, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2025.