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

The Hospital for Sick Children

Status: Completed

Conditions: Diabetes Mellitus, Type 1

Treatments: Device: bant iPhone application

Study type: Interventional

Funder types: Other

Identifiers

NCT01899274

11054 (Registry Identifier)

1000036524

Details and patient eligibility

About

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).

Full 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.

Enrollment: 92 patients

Sex: All

Ages: 11 to 16 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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92 participants in 2 patient groups

bant Group

Experimental group

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.

Treatment:

Device: bant iPhone application

Control Group

No Intervention group

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.