Diabetes Mellitus, Type 1
Conditions
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.
Interventions
DEVICEbant iPhone application
Sponsors
Thrasher Research Fund
University Health Network, Toronto
York University
The Hospital for Sick Children
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
11 Years to 16 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Hemoglobin A1C levels | 12 month RCT duration | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hypoglycemic Events | 12 month RCT duration | Hypoglycemic events will be measured at baseline, and every following 3 months (for 1 year). These will include both severe hypoglycemic events (requiring assistance of another individual with a BG \<2.8 mmol/l and/or reversal of symptoms with oral or intravenous carbohydrate/glucose) and mild hypoglycemic events (BG \<3.4mmol/L). |
| Self-Efficacy | 12 month RCT duration | Participant Self-Efficacy will be measured using verified survey and questionnaire tools. Data will be collected at baseline and every following 3 months (for 1 year). |
| Self-Care Behaviour | 12 month RCT duration | Self-Care Behaviour will be measured using verified survey and questionnaire tools. Data will be collected at baseline and every following 3 months (for 1 year). |
| Treatment Adherence | 12 month RCT duration | Participant Treatment Adherence will be measured using verified survey and questionnaire tools. Data will be collected at baseline and every following 3 months (for 1 year). |
| Quality of Life | 12 month RCT duration | Participant Quality of Life will be measured using verified survey and questionnaire tools. Data will be collected at baseline and every following 3 months (for 1 year). |
| bant Component Usage | 12 month RCT duration | Usage rates of various bant components, such as social networking and rewards, will be monitored and correlated with changes in primary and secondary outcome measures. |
Countries
Canada
Outcome results
None listed