Clinical trial NCT03091517: A Single Arm Feasibility Study of GlycoLeap, an On-line Lifestyle Modification and Self-management Program for People With Type 2 Diabetes
Official title: A Single Arm Feasibility Study of GlycoLeap, an On-line Lifestyle Modification and Self-management Program for People With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes Mellitus
Keywords: Online lifestyle modification
Self-management
HbA1c
Lead sponsor: Duke-NUS Graduate Medical School
Sponsor class: OTHER
Collaborators: name: SingHealth Polyclinics
First posted: 2017-03-27
Enrollment: 100
Sex: ALL
Minimum age (years): 21
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Age 21 - 70 years
2. Medical diagnosis of Type 2 diabetes in electronic health records or based on World Health Organisation diagnostic criteria
3. Last HbA1c result within 2 months of ≥ 7.5%
4. BMI \> 23 kg/m2 (if Asian) or BMI \> 25 kg/m2 (if non-Asian)
5. Not on insulin
6. Owns a smartphone (iPhone or Android phone) and able to use it

Exclusion Criteria:

1. Last HbA1c blood test older than 2 months
2. Cancer requiring treatment in past 5 years
3. Cardiovascular disease (heart attack or cardiac procedure within past 3 months)
4. Stroke or history/treatment for transient ischemic attacks in past 3 months
5. Chronic renal failure or dialysis
6. Amputation of lower limbs
7. Current use of medication for weight loss
8. Chronic treatment with systemic corticosteroids
9. History of bariatric surgery or extensive bowel resection
10. Unable to understand English

Primary outcomes:
measure: Change in HbA1c levels (Effectiveness)
timeFrame: Baseline, Month 6
Secondary outcomes:
measure: Change in weight (Effectiveness)
timeFrame: Baseline, Month 6
measure: Proportion of individuals who are willing to participate (Reach)
timeFrame: Baseline
measure: Extent of engagement in completing online health lessons (Implementation)
timeFrame: Throughout 6 month intervention duration
measure: Extent of engagement in submitting blood glucose logs (Implementation)
timeFrame: Throughout 6 month intervention duration
measure: Extent of engagement in submitting weight logs (Implementation)
timeFrame: Throughout 6 month intervention duration
measure: Extent of engagement in submitting meal logs (Implementation)
timeFrame: Throughout 6 month intervention duration
measure: Extent of engagement with health coach (Implementation)
timeFrame: Throughout 6 month intervention duration
measure: Change in HbA1c (primary outcome) as a function of program engagement (Effectiveness)
timeFrame: Baseline, Month 6, Throughout 6 month intervention duration
measure: Change in weight loss (secondary outcome) as a function of program engagement (Effectiveness)
timeFrame: Baseline, Month 6, Throughout 6 month intervention duration
measure: Degree of user satisfaction with the GlycoLeap program (Maintenance)
timeFrame: Month 6
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: SingHealth Polyclinics - Tampines
Study officials:
References:
citation: 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.