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

The Hospital for Sick Children92 enrolled

Overview

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).

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Diabetes Mellitus, Type 1

Interventions

bant iPhone applicationDEVICE

Eligibility

Sex: ALLMin age: 11 YearsMax age: 16 Years

Medical Language ↔ Plain English

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.

Locations (2)

Trillium Health Partners

Mississauga, Ontario, Canada

The Hostpital for Sick Children

Toronto, Ontario, Canada

Outcomes

Primary Outcomes

Changes in Hemoglobin A1C levels

Hemoglobin A1C levels are a common and important measure of diabetes control, and will be collected at baseline, regular 3-month research follow-ups, a final 12-month research visit. Primary Outcome will be based on comparison of A1C values at baseline to A1C values at RCT completion (12 months). In order to assess the potential durability of the intervention, A1C values will also be recorded (from clinical visits) 6-months and 12-months post-RCT completion.