AzTrials
AzTrials

Pre-diabetesNCT04905680

GluCoach - Technology-enabled Lifestyle Intervention Study

A study testing CGM lifestyle tracking and coaching in people with Pre-diabetes, run by National University of Singapore at 1 site in Singapore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial summary

This study seeks to address two questions. Firstly, how might a suite of interventions and data feedback (activity, diet, mood*, continuous blood glucose) through coaching be effective in influencing behaviour change for individuals at-risk of developing type 2 diabetes? Secondly, what elements of coaching might be… Read more about this study

Who is it for?
Ages 21 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Pre-diabetes
What is being tested?
CGM lifestyle tracking and coaching
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
260 participants
Where
1 siteSingapore
Study dates
4 May 2021to Apr 2022
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 21 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Singaporean Citizens and Permanent Residents
  • Aged 21 to 55
  • Must be literate in English (i.e. able to read and communicate in English) because the primary mode of communication is English
  • Willing and able to use a smartphone
  • Must be at risk of developing Type 2 Diabetes, defined as:
  • Glycated haemoglobin (HbA1c) - At least 5.7% to 6.5% OR Fasting blood glucose of 6.1 to 6.9mmol/L, AND ii) BMI of at least 20kg/m2

Who cannot join

  • Non-Singaporean Citizens and Permanent Residents
  • Under age 21 or above age 55
  • Ever diagnosed as Type 1 or Type 2 Diabetic (does not include previously diagnosed GDM)
  • Pregnant or planning to be pregnant in the next 6 months or lactating
  • History of skin allergies
  • Taking medications that are known to alter blood sugar levels/ glucose tolerance e.g.
  • glucocorticoids g) History of mental illness/conditions h) Work requirement that does not allow the carrying of electronic devices (e.g., phone and smartwatch) i) Frequent overseas travelling (e.g., more frequently than once a month, daily or weekly commuting across borders etc.)

Trial locations and contacts

1 site in 1 country.

Karen Cheong contact

+65-64353673

Karen_Cheong@hpb.gov.sg

Chelsea Chang contact

+65-64353818

Chelsea_Chang@hpb.gov.sg

Singapore1 site, 1 recruiting

  • Saw Swee Hock School of Public Health, National University of Singapore

    Singapore, 117549

    Linda Tan, +65-6601 4973, linda_tan@nus.edu.sg

    Falk Müller-Riemenschneider

    Recruiting

Other trials in Singapore

About this study

This study seeks to address two questions. Firstly, how might a suite of interventions and data feedback (activity, diet, mood*, continuous blood glucose) through coaching be effective in influencing behaviour change for individuals at-risk of developing type 2 diabetes? Secondly, what elements of coaching might be extracted for automated implementation in a scalable coach-light model?

Read the detailed description

Face-to-face health coaching is a common lifestyle intervention for healthy individuals who are at risk of chronic diseases such as diabetes. However, it is highly resource-intensive and has limitations in scaling up to reach wider populations. Advances in technology present opportunities to scale health coaching to the wider population through automation, enabling the delivery of personalised messages for individuals via mobile applications.

In addition, continuous glucose monitoring (CGM) devices could also potentially augment the effectiveness of health coaching by providing coaches with a tool for coachees' self-discovery of their individual physiological responses to lifestyles and modifications such as diet and exercise.

As such, the present study seeks to leverage smart wearable devices (e.g., Bluetooth smartwatches) and CGM devices accompanying a customized mobile application to deliver lifestyle coaching interventions. This suite of lifestyle interventions, including feedback about their own blood glucose levels, aims to influence participant's lifestyles and behaviours through guided self-discovery and face-to-face coaching. This intervention will be compared with a control group to examine its effects on lifestyle change, anthropometric measures and biometric measures. In addition, the findings from this study will contribute to the development of a novel coach-light intervention that can be implemented at a wider population level via Singapore's Health Promotion Board's (HPB) existing programmes and channels.

Conditions
Pre-diabetes
Being tested
CGM lifestyle tracking and coaching
Keywords
Lifestyle coaching, mHealth
Medical subject headings
Glucose Intolerance

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CGM lifestyle tracking and coachingDevice

    Participants in the experimental group will go through a total of 5 lifestyle tracking sessions (including baseline), of which 1 will include CGM tracking. For this CGM lifestyle tracking session, experimental group participants will receive real-time feedback through the study applications, which will display the CGM trace.

    The data collected during the lifestyle tracking sessions will be discussed with the participants during 3 face-to-face coaching and 2 tele-coaching sessions, where the participants will develop and implement lifestyle change action plans.

Study groups in NCT04905680
Study groupRoleWhat they receive
Control groupNo interventionThe health screening before the study and at the end of study will collect anthropometric data (height, weight, waist and hip circumference), blood pressure data, and blood samples (for testing of HbA1c, fasting blood glucose, fasting insulin and lipid profile). Individuals are provided with an educational brochure upon receiving their screening results. Participants will then go through a baseline lifestyle tracking session using a study-issued smartphone and smartwatch, pre-installed with certain study applications. For participants in the control arm, there is no health coaching or study activities until the end of the study, where individuals will attend a 20- to 30-minute session with a coach to have their baseline lifestyle tracking results explained to them and receive personalised suggestions on lifestyle modifications.
Experimental groupExperimentalThe activities during health screening before the study and at the end of study is similar to the control. Individuals are provided with an educational brochure upon receiving their screening results. Participants will then go through a baseline lifestyle tracking session using a study-issued smartphone and smartwatch, pre-installed with certain study applications, which will be used for the lifestyle tracking sessions. The experimental arm will go through 4 additional lifestyle tracking sessions (i.e., total of 5 including baseline), of which 1 will include Continuous Glucose Monitoring (CGM) tracking. For this CGM tracking session, participants will receive real-time feedback through the study applications, which will display the CGM trace. The data collected during the lifestyle tracking sessions will be discussed with the participants during 3 face-to-face coaching and 2 tele-coaching sessions, where the participants will develop and implement lifestyle change action plans.
Receives: Device: CGM lifestyle tracking and coaching

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Behaviour, self-efficacy and attitudes

    Change in behaviour, self-efficacy and attitudes towards diet and exercise from baseline to 3rd month

    Measured: Baseline and at month 3

Secondary outcomes (5)

  1. HbA1c concentration

    Change in fasting plasma HbA1c concentration from baseline to 3rd month

    Measured: Baseline and at month 3

  2. Plasma glucose concentration

    Change in fasting plasma glucose concentration from baseline to 3rd month

    Measured: Baseline and at month 3

  3. BMI

    Change in BMI from baseline to 3rd month

    Measured: Baseline and at month 3

  4. Lipid profile

    Change in lipid profile from baseline to 3rd month

    Measured: Baseline and at month 3

  5. Systolic and Diastolic Blood pressure

    Change in systolic and diastolic blood pressure from baseline to 3rd month

    Measured: Baseline and at month 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 May 2021
  2. Study start4 May 2021
  3. Primary completionJan 2022 (estimated)
  4. Study completionApr 2022 (estimated)

Resources

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
Other
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is an experimental-control study design where up to 260 individuals at risk of developing diabetes (blood glucose levels of 6.1 to 6.9 mmol/L) will be randomly allocated to the experimental and control groups (1:1 randomization). Participants in the control group will not receive any health coaching and are not required to carry out any study activities after they have completed the baseline lifestyle tracking session. At the end of the study, they will attend a 20- to 30-minute session with a coach to have their baseline lifestyle tracking results explained to them and receive personalised suggestions on lifestyle modifications.
Masking
None (open label)
Enrolment
260 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04905680
Sponsor's protocol ID
Glucoach
Status last verified
Nov 2021
First submitted
19 May 2021
Last updated
1 Dec 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Dunkley AJ, Bodicoat DH, Greaves CJ, Russell C, Yates T, Davies MJ, Khunti K. Diabetes prevention in the real world: effectiveness of pragmatic lifestyle interventions for the prevention of type 2 diabetes and of the impact of adherence to guideline recommendations: a systematic review and meta-analysis. Diabetes Care. 2014 Apr;37(4):922-33. doi: 10.2337/dc13-2195.

    PubMed 24652723

  • Fukuoka Y, Gay CL, Joiner KL, Vittinghoff E. A Novel Diabetes Prevention Intervention Using a Mobile App: A Randomized Controlled Trial With Overweight Adults at Risk. Am J Prev Med. 2015 Aug;49(2):223-37. doi: 10.1016/j.amepre.2015.01.003. Epub 2015 May 30.

    PubMed 26033349

  • Block G, Azar KM, Romanelli RJ, Block TJ, Hopkins D, Carpenter HA, Dolginsky MS, Hudes ML, Palaniappan LP, Block CH. Diabetes Prevention and Weight Loss with a Fully Automated Behavioral Intervention by Email, Web, and Mobile Phone: A Randomized Controlled Trial Among Persons with Prediabetes. J Med Internet Res. 2015 Oct 23;17(10):e240. doi: 10.2196/jmir.4897.

    PubMed 26499966

  • Knowler WC, Barrett-Connor E, Fowler SE, Hamman RF, Lachin JM, Walker EA, Nathan DM; Diabetes Prevention Program Research Group. Reduction in the incidence of type 2 diabetes with lifestyle intervention or metformin. N Engl J Med. 2002 Feb 7;346(6):393-403. doi: 10.1056/NEJMoa012512.

    PubMed 11832527

Questions about this trial

What is this clinical trial studying?

A study testing CGM lifestyle tracking and coaching in people with Pre-diabetes, run by National University of Singapore at 1 site in Singapore.

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 6 inclusion and 7 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: status not confirmed, as of the sponsor's last update on 1 Dec 2021. 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 Singapore. 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Karen Cheong (+65-64353673, Karen_Cheong@hpb.gov.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Behaviour, self-efficacy and attitudes (time frame: Baseline and at month 3). 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 NCT04905680, which also lists 4 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 1 Dec 2021.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in