NCT02813343

Brief Summary

This is a mixed methods study that evaluates the effectiveness of the BlueStar app and its implementation in 3 hospital/health system sites across Ontario. The 6 month study includes 300 participants that are randomized to an immediate treatment group or a delayed intervention group. The primary outcomes include changes in HbA1c and patient reported outcomes and experience measures. Qualitative interviews with various stakeholders will explore issues relating to successful implementation.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
221

participants targeted

Target at P75+ for not_applicable type-2-diabetes

Timeline
Completed

Started Apr 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

June 13, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

June 27, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2017

Completed
Last Updated

September 14, 2017

Status Verified

September 1, 2017

Enrollment Period

1.2 years

First QC Date

June 13, 2016

Last Update Submit

September 12, 2017

Conditions

Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • Glucose control (HbA1c levels)

    Change in HbA1c from baseline to 6 months

    Baseline, 3 months and 6 months

Secondary Outcomes (11)

  • Patient reported health outcomes and utilization - ER visit

    Baseline, 3 months and 6 months

  • Patient reported health outcomes and utilization - Hypoglycemic episodes

    Baseline, 3 months and 6 months

  • Patient reported health outcomes and utilization - Hospitalizations

    Baseline, 3 months and 6 months

  • Patient reported health outcomes and utilization - Physician visits

    Baseline, 3 months and 6 months

  • Patient reported health outcomes and utilization - Med Adherence

    Baseline, 3 months and 6 months

  • +6 more secondary outcomes

Study Arms (2)

Immediate Treatment Group

EXPERIMENTAL

The Immediate Treatment group will receive access to the study intervention - BlueStar app, immediately after consenting for a total duration of 6 months.

Device: BlueStar app

Delayed Treatment Group

OTHER

The Delayed Treatment group will receive access to the study intervention - BlueStar app, 3 months after consenting for a total duration of 3 months.

Device: BlueStar app

Interventions

BlueStar appDEVICE

BlueStar is a smart-phone enabled application that is designed to serve as a virtual coach for patients. The app sends daily evidence-based, real-time messages as well as longitudinal feedback on how to improve diabetes management. The Bluestar app has been shown to be effective at teaching patients about dietary impacts on their blood glucose levels, encouraging patients to generate higher-quality blood glucose data for enhanced self-monitoring, and to improve overall management of diabetes as represented by reductions in levels of HgbA1c. Benefits have been demonstrated in time periods as brief as three months. One US based study showed a decrease in hospitalizations and emergency department visits among participants who use the application.

Delayed Treatment GroupImmediate Treatment Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults, 18 years or older, currently being treated for Type II diabetes
  • HgbA1C greater or equal to 8.0% and at least 1.0% above target within the last 3 months
  • Have a functional email address or be willing to obtain one
  • Be functional in reading the English language (self reported)

You may not qualify if:

  • Have Type I diabetes or Latent autoimmune diabetes of adults (LADA)
  • Are on continuous glucose monitoring
  • Have an insulin pump
  • Are on dialysis
  • Are pregnant.
  • Are unable to use a computer or mobile phone due to severe mental or physical impairment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Women's College Hospital

Toronto, Ontario, M5S 1B2, Canada

Location

Related Publications (7)

  • Quinn CC, Clough SS, Minor JM, Lender D, Okafor MC, Gruber-Baldini A. WellDoc mobile diabetes management randomized controlled trial: change in clinical and behavioral outcomes and patient and physician satisfaction. Diabetes Technol Ther. 2008 Jun;10(3):160-8. doi: 10.1089/dia.2008.0283.

    PMID: 18473689BACKGROUND

  • Katz R, Mesfin T, Barr K. Lessons from a community-based mHealth diabetes self-management program: "it's not just about the cell phone". J Health Commun. 2012;17 Suppl 1:67-72. doi: 10.1080/10810730.2012.650613.

    PMID: 22548601BACKGROUND

  • Pawson R. The science of evaluation: a realist manifesto. Sage. 2013.

    BACKGROUND

  • Marchal B, van Belle S, van Olmen J, Hoerée T, Kegels G. Is realist evaluation keepings its promise? A review of published empirical studies in the field of health systems research. Evaluation. 2012;18(2):192-212.

    BACKGROUND

  • Braun V, Clarke V. Using thematic analysis in psychology. Qualitative Research in Psychology. 2006;3(2):77-101.

    BACKGROUND

  • Agarwal P, Mukerji G, Desveaux L, Ivers NM, Bhattacharyya O, Hensel JM, Shaw J, Bouck Z, Jamieson T, Onabajo N, Cooper M, Marani H, Jeffs L, Bhatia RS. Mobile App for Improved Self-Management of Type 2 Diabetes: Multicenter Pragmatic Randomized Controlled Trial. JMIR Mhealth Uhealth. 2019 Jan 10;7(1):e10321. doi: 10.2196/10321.

    PMID: 30632972DERIVED

  • Desveaux L, Agarwal P, Shaw J, Hensel JM, Mukerji G, Onabajo N, Marani H, Jamieson T, Bhattacharyya O, Martin D, Mamdani M, Jeffs L, Wodchis WP, Ivers NM, Bhatia RS. A randomized wait-list control trial to evaluate the impact of a mobile application to improve self-management of individuals with type 2 diabetes: a study protocol. BMC Med Inform Decis Mak. 2016 Nov 15;16(1):144. doi: 10.1186/s12911-016-0381-5.

    PMID: 27842539DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Sacha Bhatia, MD, FRCP(C)

    Women's College Hospital Institute for Health Systems Solutions and Virtual Care (WIHV)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
SUPPORTIVE CARE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 13, 2016

First Posted

June 27, 2016

Study Start

April 1, 2016

Primary Completion

June 1, 2017

Study Completion

June 1, 2017

Last Updated

September 14, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will share

There are agreements in place to share individual participant data between all the study sites and Women's College Hospital

Locations

CA(1)