A Single Arm Feasibility Study of GlycoLeap, an On-line Lifestyle Modification and Self-management Program for People With Type 2 Diabetes

Duke University

Status: Completed

Conditions: Type 2 Diabetes Mellitus

Treatments: Behavioral: GlycoLeap

Study type: Interventional

Funder types: Other

Identifiers

NCT03091517

GlycoLeap

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 21 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

GlycoLeap

Other group

Description:

Since this is a single arm study, all participants will receive the GlycoLeap intervention.

Treatment:

Behavioral: GlycoLeap