Assessment of an iPhone Application on Glycemic Control in Type 1 Diabetes

Assessment of an Electronic Self-Management Tool on Glycemic Control in Teens With Type 1 Diabetes

Sponsors

Lead Sponsor: The Hospital for Sick Children

Collaborator: Thrasher Research Fund
University Health Network, Toronto
York University

Source The Hospital for Sick Children
Brief Summary

The purpose of the study is to assess whether an electronic self-management tool, specifically an iPhone application entitled bant, can improve glycemic control in Adolescents who have Type 1 Diabetes Mellitus (T1DM).

Detailed Description

Type 1 Diabetes Mellitus (T1DM) is among the most common chronic diseases affecting children, adolescents and adults. While intensive patient self-management can optimize Blood Glucose (BG) to near-normal levels, it is a challenge for many TIDM patients to continuously achieve this. These difficulties are compounded in the adolescent population, who struggle with daily self-management and therefore may increase their risk of T1DM complications.

Due to this observation an electronic self-management tool, in the form of an iPhone application called bant, was developed. This app guides the analysis of BG data and suggests changes in treatment, while also using social network and rewards to encourage and reinforce self-care behaviors, such as frequent self-monitoring of blood glucose levels (SMBG). By primarily measuring changes in HbA1C levels, the study will assess if bant and its features are associated with improved glycemic control in the adolescents who use it.

Overall Status Completed
Start Date July 2013
Completion Date January 2016
Primary Completion Date January 2016
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Changes in Hemoglobin A1C levels 12 month RCT duration
Secondary Outcome
Measure Time Frame
Hypoglycemic Events 12 month RCT duration
Self-Efficacy 12 month RCT duration
Self-Care Behaviour 12 month RCT duration
Treatment Adherence 12 month RCT duration
Quality of Life 12 month RCT duration
bant Component Usage 12 month RCT duration
Enrollment 92
Condition
Intervention

Intervention Type: Device

Intervention Name: bant iPhone application

Arm Group Label: bant Group

Eligibility

Criteria:

Inclusion Criteria:

- T1DM as defined by 2008 Canadian Diabetes Association (CDA,2008)guidelines, with duration ≥ 1 year

- Age 11-16 years, inclusive at enrollment in the trial

- 2 of the participant's last 3 A1C results prior to enrollment, including the most recent, falling between 8.0% - 10.5%

- Have been followed for at least 6 months in the current diabetes clinic

Exclusion Criteria:

- Non-English speaking adolescents as the version of bant being used in the randomized control trial (RCT) is only offered in English at this time.

Gender: All

Minimum Age: 11 Years

Maximum Age: 16 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Mark R Palmert, M.D., Ph.D. Principal Investigator The Hospital for Sick Children
Location
Facility:
Trillium Health Partners | Mississauga, Ontario, L5B 1B8, Canada
The Hostpital for Sick Children | Toronto, Ontario, M5G 1X8, Canada
Location Countries

Canada

Verification Date

April 2016

Responsible Party

Type: Principal Investigator

Investigator Affiliation: The Hospital for Sick Children

Investigator Full Name: Mark Palmert

Investigator Title: Head of Division of Endocrinology

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: bant Group

Type: Experimental

Description: Subjects in the bant Group will receive care as usual, as well as an iPhone loaded with the bant iPhone application and a bluetooth enabled glucometer. Participants will have their A1C levels measured every 3 months (for 1 year), and also complete questionnaires/interviews relating to their diabetes management and lifestyle.

Label: Control Group

Type: No Intervention

Description: Subjects in the control group will continue care as usual with their diabetes team, without supplementation of the bant application. Participants will have their A1C levels measured every 3 months (for 1 year), as well as complete questionnaires/interviews relating to their diabetes management and lifestyle.

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov