Clinical trial NCT01899274: Assessment of an iPhone Application on Glycemic Control in Type 1 Diabetes
Official title: Assessment of an Electronic Self-Management Tool on Glycemic Control in Teens With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
Collaborators: name: Thrasher Research Fund
name: University Health Network, Toronto
name: York University
First posted: 2013-07-15
Enrollment: 92
Sex: ALL
Minimum age (years): 11
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Changes in Hemoglobin A1C levels
timeFrame: 12 month RCT duration
Secondary outcomes:
measure: Hypoglycemic Events
timeFrame: 12 month RCT duration
measure: Self-Efficacy
timeFrame: 12 month RCT duration
measure: Self-Care Behaviour
timeFrame: 12 month RCT duration
measure: Treatment Adherence
timeFrame: 12 month RCT duration
measure: Quality of Life
timeFrame: 12 month RCT duration
measure: bant Component Usage
timeFrame: 12 month RCT duration
Other outcomes:
Locations:
city: Mississauga
country: Canada
facility: Trillium Health Partners
state: Ontario
city: Toronto
country: Canada
facility: The Hostpital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Mark R Palmert, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cafazzo JA, Casselman M, Hamming N, Katzman DK, Palmert MR. Design of an mHealth app for the self-management of adolescent type 1 diabetes: a pilot study. J Med Internet Res. 2012 May 8;14(3):e70. doi: 10.2196/jmir.2058.
citation: Goyal S, Nunn CA, Rotondi M, Couperthwaite AB, Reiser S, Simone A, Katzman DK, Cafazzo JA, Palmert MR. A Mobile App for the Self-Management of Type 1 Diabetes Among Adolescents: A Randomized Controlled Trial. JMIR Mhealth Uhealth. 2017 Jun 19;5(6):e82. doi: 10.2196/mhealth.7336.