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

NCT03091517 | Completed

• 1 other identifier: GlycoLeap
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 2 Diabetes Mellitus

Keywords

Online lifestyle modification; Self-management; HbA1c

Outcome Measures

Primary Outcomes (1)

• Change in HbA1c levels (Effectiveness)

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

  Baseline, Month 6

Secondary Outcomes (10)

• Change in weight (Effectiveness)

  Baseline, Month 6

• Proportion of individuals who are willing to participate (Reach)

  Baseline

• Extent of engagement in completing online health lessons (Implementation)

  Throughout 6 month intervention duration

• Extent of engagement in submitting blood glucose logs (Implementation)

  Throughout 6 month intervention duration

• Extent of engagement in submitting weight logs (Implementation)

  Throughout 6 month intervention duration

Study Arms (1)

GlycoLeap

OTHER

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

Behavioral: GlycoLeap

Interventions

GlycoLeap BEHAVIORAL

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.

GlycoLeap

Eligibility Criteria

• Age: 21 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Current use of medication for weight loss
• Chronic treatment with systemic corticosteroids
• History of bariatric surgery or extensive bowel resection
• Unable to understand English

Sponsors & Collaborators

• Duke-NUS Graduate Medical School: lead
• SingHealth Polyclinics: collaborator

Study Sites (1)

SingHealth Polyclinics - Tampines

Singapore, 529203, Singapore

Location

Related Publications (1)

• 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.

  PMID: 31127720 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 21, 2017
• First Posted: March 27, 2017
• Study Start: June 22, 2017
• Primary Completion: May 19, 2018
• Study Completion: May 28, 2018
• Last Updated: July 11, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)