Assessment of an Electronic Self-Management Tool on Glycemic Control in Teens With Type 1 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Changes in Hemoglobin A1C levels
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 11 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
bant Group
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.
干预措施: bant iPhone application (Device)
Control Group
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.
结局指标
主要结局
Changes in Hemoglobin A1C levels
时间窗: 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.
次要结局
- Treatment Adherence(12 month RCT duration)
- bant Component Usage(12 month RCT duration)
- Hypoglycemic Events(12 month RCT duration)
- Self-Efficacy(12 month RCT duration)
- Self-Care Behaviour(12 month RCT duration)
- Quality of Life(12 month RCT duration)
研究者
Mark Palmert
Head of Division of Endocrinology
The Hospital for Sick Children