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

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ClinicalTrials.gov Identifier: NCT03091517
Recruitment Status : Completed
First Posted : March 27, 2017
Last Update Posted : July 11, 2018
Sponsor:
Collaborator:
SingHealth Polyclinics
Information provided by (Responsible Party):
Eric A. Finkelstein, Duke-NUS Graduate Medical School

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.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Mellitus Behavioral: GlycoLeap Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Single Arm Feasibility Study of GlycoLeap, an On-line Lifestyle Modification and Self-management Program for People With Type 2 Diabetes
Actual Study Start Date : June 22, 2017
Actual Primary Completion Date : May 19, 2018
Actual Study Completion Date : May 28, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
GlycoLeap
Since this is a single arm study, all participants will receive the GlycoLeap intervention.
Behavioral: GlycoLeap

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.





Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Change in weight (Effectiveness) [ Time Frame: Baseline, Month 6 ]
    We will assess change in weight

  2. Proportion of individuals who are willing to participate (Reach) [ Time Frame: Baseline ]
    Percentage of participants offered the GlycoLeap programme who agree to enrol

  3. Extent of engagement in completing online health lessons (Implementation) [ Time Frame: Throughout 6 month intervention duration ]
    Number of online GlycoLeap health lessons completed

  4. Extent of engagement in submitting blood glucose logs (Implementation) [ Time Frame: Throughout 6 month intervention duration ]
    Number of blood glucose measurements logged per week in GlycoLeap's smartphone app

  5. Extent of engagement in submitting weight logs (Implementation) [ Time Frame: Throughout 6 month intervention duration ]
    Number of weight measurements logged per week in GlycoLeap's smartphone app

  6. Extent of engagement in submitting meal logs (Implementation) [ Time Frame: Throughout 6 month intervention duration ]
    Number of meals logged per week in GlycoLeap's smartphone app

  7. Extent of engagement with health coach (Implementation) [ Time Frame: Throughout 6 month intervention duration ]
    Number of messages sent to health coaches per week through GlycoLeap's smartphone app

  8. Change in HbA1c (primary outcome) as a function of program engagement (Effectiveness) [ Time Frame: Baseline, Month 6, Throughout 6 month intervention duration ]
    We will test whether those with greater engagement with the GlycoLeap program show greater improvements in HbA1c (primary outcome).

  9. Change in weight loss (secondary outcome) as a function of program engagement (Effectiveness) [ Time Frame: Baseline, Month 6, Throughout 6 month intervention duration ]
    We will test whether those with greater engagement with the GlycoLeap program show greater improvements in weight loss (secondary outcome).

  10. Degree of user satisfaction with the GlycoLeap program (Maintenance) [ Time Frame: Month 6 ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03091517


Locations
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Singapore
SingHealth Polyclinics - Tampines
Singapore, Singapore, 529203
Sponsors and Collaborators
Duke-NUS Graduate Medical School
SingHealth Polyclinics

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Eric A. Finkelstein, Professor, Duke-NUS Graduate Medical School
ClinicalTrials.gov Identifier: NCT03091517     History of Changes
Other Study ID Numbers: GlycoLeap
First Posted: March 27, 2017    Key Record Dates
Last Update Posted: July 11, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We do not plan to make individual participant data available to other researchers.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eric A. Finkelstein, Duke-NUS Graduate Medical School:
Online lifestyle modification
Self-management
HbA1c
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases