Type 2 Diabetes MellitusNCT03091517
A Single Arm Feasibility Study of GlycoLeap, an On-line Lifestyle Modification and Self-management Program for People With Type 2 Diabetes
A study testing GlycoLeap in people with Type 2 Diabetes Mellitus, run by Duke-NUS Graduate Medical School at 1 site in Singapore.
Trial summary
This single arm pilot study will explore the feasibility of GlycoLeap, a proprietary online lifestyle modification and self-management education program developed in Singapore for people with type 2 diabetes, as an add-on to primary care delivered through one of the SingHealth Polyclinics. Read more about this study
- Who is it for?
- Ages 21 to 70 years
- Conditions the study is for
- Type 2 Diabetes Mellitus
- What is being tested?
- GlycoLeap
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSingapore
- Study dates
- 22 Jun 2017to 28 May 2018
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 21 - 70 years
- Medical diagnosis of Type 2 diabetes in electronic health records or based on World Health Organisation diagnostic criteria
- Last HbA1c result within 2 months of ≥ 7.5%
- BMI > 23 kg/m2 (if Asian) or BMI > 25 kg/m2 (if non-Asian)
- Not on insulin
- Owns a smartphone (iPhone or Android phone) and able to use it
Who cannot join
- Last HbA1c blood test older than 2 months
- Cancer requiring treatment in past 5 years
- Cardiovascular disease (heart attack or cardiac procedure within past 3 months)
- Stroke or history/treatment for transient ischemic attacks in past 3 months
- Chronic renal failure or dialysis
- Amputation of lower limbs
Show all 10Show fewer
- Current use of medication for weight loss
- Chronic treatment with systemic corticosteroids
- History of bariatric surgery or extensive bowel resection
- Unable to understand English
Trial locations and contacts
1 site in 1 country.
About this study
This single arm pilot study will explore the feasibility of GlycoLeap, a proprietary online lifestyle modification and self-management education program developed in Singapore for people with type 2 diabetes, as an add-on to primary care delivered through one of the SingHealth Polyclinics.
Read the detailed description
Lifestyle modification - focusing on a healthy diet, regular exercise and behaviour change - are the mainstay of first-line therapies in managing diabetes. There is strong evidence that lifestyle interventions can result in modest weight loss and improvements in clinical metrics such as glycated haemoglobin (HbA1c), blood pressure and cholesterol. For people with type 2 diabetes, lifestyle modification and self-management education can lead to improved clinical outcomes and reduced risks of complications.
Operationally, such interventions are often difficult to administer in the primary care and community setting because of lack of provider time/resources/training and difficulty in engaging patients. Fortunately, there is a growing body of evidence which shows that online programs and smartphone-based interventions can lead to improved clinical outcomes like weight loss and HbA1c reduction. Moreover, these interventions can be disseminated to a larger group of people and at a low cost. However, results from community based studies often fail to live up to what is achieved in clinical trials due to lack of clinician oversight and support. Without this support, patients often fail to engage in the intervention to the levels required for health benefits to materialize.
This feasibility study will explore the use of GlycoLeap, a proprietary online lifestyle modification and self-management education program developed in Singapore for people with type 2 diabetes, as an add-on to primary care delivered through one of the SingHealth Polyclinics. The goal of the study is to test whether patients with diabetes who receive care at the clinic are amenable to such an intervention, to quantify program fidelity for those who do enroll in the study, and to explore the extent to which the intervention can be used in conjunction with primary care in efforts to improve health outcomes.
- Conditions
- Type 2 Diabetes Mellitus
- Being tested
- GlycoLeap
- Keywords
- Online lifestyle modification, Self-management, HbA1c
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlycoLeapBehavioural
GlycoLeap is a 24-week programme includes the following features:
Interactive Education Lessons: Beginning week 1, the participant will be presented with a diabetes self-management education curriculum. These lessons are divided into 6 phases, and each lesson is fully accessible online from a computer or mobile phone, and takes approximately 10 - 15 minutes to complete.
The Glyco Mobile Application: During the 24 week intervention period, the participant will use the Glyco mobile application that allows them to track their weight (measured on the wireless weighing scale), self-tested glucose readings (measured using the glucometer kit), and log their foods and meals by taking photos using their phone. A health coach will review the participant's data regularly, provide personalised feedback.
| Study group | Role | What they receive |
|---|---|---|
| GlycoLeap | Other | Since this is a single arm study, all participants will receive the GlycoLeap intervention. Receives: Behavioral: GlycoLeap |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HbA1c levels (Effectiveness)
HbA1c or glycated haemoglobin is a measure of blood glucose levels. We will assess change in HbA1c levels.
Measured: Baseline, Month 6
Secondary outcomes (10)
Change in weight (Effectiveness)
We will assess change in weight
Measured: Baseline, Month 6
Proportion of individuals who are willing to participate (Reach)
Percentage of participants offered the GlycoLeap programme who agree to enrol
Measured: Baseline
Extent of engagement in completing online health lessons (Implementation)
Number of online GlycoLeap health lessons completed
Measured: Throughout 6 month intervention duration
Extent of engagement in submitting blood glucose logs (Implementation)
Number of blood glucose measurements logged per week in GlycoLeap's smartphone app
Measured: Throughout 6 month intervention duration
Extent of engagement in submitting weight logs (Implementation)
Number of weight measurements logged per week in GlycoLeap's smartphone app
Measured: Throughout 6 month intervention duration
Extent of engagement in submitting meal logs (Implementation)
Number of meals logged per week in GlycoLeap's smartphone app
Measured: Throughout 6 month intervention duration
Extent of engagement with health coach (Implementation)
Number of messages sent to health coaches per week through GlycoLeap's smartphone app
Measured: Throughout 6 month intervention duration
Change in HbA1c (primary outcome) as a function of program engagement (Effectiveness)
We will test whether those with greater engagement with the GlycoLeap program show greater improvements in HbA1c (primary outcome).
Measured: Baseline, Month 6, Throughout 6 month intervention duration
Change in weight loss (secondary outcome) as a function of program engagement (Effectiveness)
We will test whether those with greater engagement with the GlycoLeap program show greater improvements in weight loss (secondary outcome).
Measured: Baseline, Month 6, Throughout 6 month intervention duration
Degree of user satisfaction with the GlycoLeap program (Maintenance)
We will conduct a preliminary assessment of maintenance at the individual level via a user satisfaction survey at the month 6 follow-up. Participants will rate the smartphone app on a scale of 1 (Poor) to 5 (Excellent) and whether they would recommend the app to others for managing their diabetes on a scale of 1 (Would not recommend) to 5 (Would highly recommend).
Measured: Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2017
- Study start22 Jun 2017
- Primary completion19 May 2018
- Study completion28 May 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke-NUS Graduate Medical School
- Sponsor type
- University, hospital or other
- Collaborators
- SingHealth Polyclinics
- Responsible party
- Principal investigator, Eric A. Finkelstein, Duke-NUS Graduate Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03091517
- Sponsor's protocol ID
- GlycoLeap
- Status last verified
- Jul 2018
- First submitted
- 21 Mar 2017
- Last updated
- 11 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We do not plan to make individual participant data available to other researchers.
Publications
Koot D, Goh PSC, Lim RSM, Tian Y, Yau TY, Tan NC, Finkelstein EA. A Mobile Lifestyle Management Program (GlycoLeap) for People With Type 2 Diabetes: Single-Arm Feasibility Study. JMIR Mhealth Uhealth. 2019 May 24;7(5):e12965. doi: 10.2196/12965.
PubMed 31127720
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Arm Feasibility Study of GlycoLeap, an On-line Lifestyle Modification and Self-management Program for People With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT03091517
- Acronym / sponsor ID
- GlycoLeap
- Conditions
- Type 2 Diabetes Mellitus
- Keywords
- Online lifestyle modification, Self-management, HbA1c
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Duke-NUS Graduate Medical SchoolUniversity, hospital or other
- Collaborators
- SingHealth Polyclinics
- Study start
- 22 Jun 2017 (actual)
- Primary completion
- 19 May 2018 (actual)
- Study completion
- 28 May 2018 (actual)
- First posted
- 27 Mar 2017 (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.
This single arm pilot study will explore the feasibility of GlycoLeap, a proprietary online lifestyle modification and self-management education program developed in Singapore for people with type 2 diabetes, as an add-on to primary care delivered through one of the SingHealth Polyclinics.
Detailed description
Lifestyle modification - focusing on a healthy diet, regular exercise and behaviour change - are the mainstay of first-line therapies in managing diabetes. There is strong evidence that lifestyle interventions can result in modest weight loss and improvements in clinical metrics such as glycated haemoglobin (HbA1c), blood pressure and cholesterol. For people with type 2 diabetes, lifestyle modification and self-management education can lead to improved clinical outcomes and reduced risks of complications.
Operationally, such interventions are often difficult to administer in the primary care and community setting because of lack of provider time/resources/training and difficulty in engaging patients. Fortunately, there is a growing body of evidence which shows that online programs and smartphone-based interventions can lead to improved clinical outcomes like weight loss and HbA1c reduction. Moreover, these interventions can be disseminated to a larger group of people and at a low cost. However, results from community based studies often fail to live up to what is achieved in clinical trials due to lack of clinician oversight and support. Without this support, patients often fail to engage in the intervention to the levels required for health benefits to materialize.
This feasibility study will explore the use of GlycoLeap, a proprietary online lifestyle modification and self-management education program developed in Singapore for people with type 2 diabetes, as an add-on to primary care delivered through one of the SingHealth Polyclinics. The goal of the study is to test whether patients with diabetes who receive care at the clinic are amenable to such an intervention, to quantify program fidelity for those who do enroll in the study, and to explore the extent to which the intervention can be used in conjunction with primary care in efforts to improve health outcomes.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GlycoLeap | Other | Behavioral: GlycoLeapSince this is a single arm study, all participants will receive the GlycoLeap intervention. |
Who may qualify
- Ages
- 21 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 21 - 70 years
- Medical diagnosis of Type 2 diabetes in electronic health records or based on World Health Organisation diagnostic criteria
- Last HbA1c result within 2 months of ≥ 7.5%
- BMI > 23 kg/m2 (if Asian) or BMI > 25 kg/m2 (if non-Asian)
- Not on insulin
Key exclusion criteria (10 listed)
- Last HbA1c blood test older than 2 months
- Cancer requiring treatment in past 5 years
- Cardiovascular disease (heart attack or cardiac procedure within past 3 months)
- Stroke or history/treatment for transient ischemic attacks in past 3 months
- Chronic renal failure or dialysis
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 |
|---|---|---|
| GlycoLeapGlycoLeap is a 24-week programme includes the following features: Interactive Education Lessons: Beginning week 1, the participant will be presented with a diabetes self-management education curriculum. These lessons are divided into 6 phases, and each lesson is fully accessible online from a computer or mobile phone, and takes approximately 10 - 15 minutes to complete. The Glyco Mobile Application: During the 24 week intervention period, the participant will use the Glyco mobile application that allows them to track their weight (measured on the wireless weighing scale), self-tested glucose readings (measured using the glucometer kit), and log their foods and meals by taking photos using their phone. A health coach will review the participant's data regularly, provide personalised feedback. | Behavioural | GlycoLeap |
Primary outcome
Change in HbA1c levels (Effectiveness)
Time frame: Baseline, Month 6
HbA1c or glycated haemoglobin is a measure of blood glucose levels. We will assess change in HbA1c levels.
10 secondary outcomes
Change in weight (Effectiveness)
Time frame: Baseline, Month 6
Proportion of individuals who are willing to participate (Reach)
Time frame: Baseline
Extent of engagement in completing online health lessons (Implementation)
Time frame: Throughout 6 month intervention duration
Extent of engagement in submitting blood glucose logs (Implementation)
Time frame: Throughout 6 month intervention duration
Extent of engagement in submitting weight logs (Implementation)
Time frame: Throughout 6 month intervention duration
Extent of engagement in submitting meal logs (Implementation)
Time frame: Throughout 6 month intervention duration
Extent of engagement with health coach (Implementation)
Time frame: Throughout 6 month intervention duration
Change in HbA1c (primary outcome) as a function of program engagement (Effectiveness)
Time frame: Baseline, Month 6, Throughout 6 month intervention duration
Change in weight loss (secondary outcome) as a function of program engagement (Effectiveness)
Time frame: Baseline, Month 6, Throughout 6 month intervention duration
Degree of user satisfaction with the GlycoLeap program (Maintenance)
Time frame: Month 6
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 Jul 2018.
- Derived from this study: PubMed 31127720Koot D, Goh PSC, Lim RSM, Tian Y, Yau TY, Tan NC, Finkelstein EA. A Mobile Lifestyle Management Program (GlycoLeap) for People With Type 2 Diabetes: Single-Arm Feasibility Study. JMIR Mhealth Uhealth. 2019 May 24;7(5):e12965. doi: 10.2196/12965.
- Individual participant dataSharing planned: No. We do not plan to make individual participant data available to other researchers.
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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 GlycoLeap in people with Type 2 Diabetes Mellitus, run by Duke-NUS Graduate Medical School 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 10 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 Jul 2018. 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?
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?
Change in HbA1c levels (Effectiveness) (time frame: Baseline, Month 6). 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 NCT03091517, which also lists 1 linked publication.
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 Jul 2018.