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

Duke-NUS Graduate Medical School100 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

100

Conditions

Type 2 Diabetes Mellitus

Interventions

GlycoLeapBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (1)

SingHealth Polyclinics - Tampines

Singapore, Singapore

Outcomes

Primary Outcomes

Change in HbA1c levels (Effectiveness)

HbA1c or glycated haemoglobin is a measure of blood glucose levels. We will assess change in HbA1c levels.

Time frame: Baseline, Month 6

Secondary Outcomes

Change in weight (Effectiveness)

We will assess change in weight

Time frame: Baseline, Month 6

Proportion of individuals who are willing to participate (Reach)

Percentage of participants offered the GlycoLeap programme who agree to enrol

Time frame: Baseline

Extent of engagement in completing online health lessons (Implementation)

Number of online GlycoLeap health lessons completed

Time frame: 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

Time frame: 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

Time frame: Throughout 6 month intervention duration

Extent of engagement in submitting meal logs (Implementation)

Number of meals logged per week in GlycoLeap's smartphone app

Time frame: Throughout 6 month intervention duration

Extent of engagement with health coach (Implementation)

Data from ClinicalTrials.gov

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