Assessing the Impact of Control-IQ Technology on Quality of Life and Glycemic Control in Children and Youth With Type 1 Diabetes in a Canadian Context
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- INsulin delivery Systems: Perceptions, Ideas, Reflections and Expectations Questionnaire Post Intervention (Youth and Parent Versions)
研究概览
简要总结
This is a single-centre, mixed-methods, prospective study in pediatric patients with T1D initiating Control-IQ technology on the Tandem t-slim X2 insulin pump.
Primary Objective:
To determine pediatric T1D patients' and their parents' perceptions of the impact of Control-IQ on their psychosocial functioning and quality of life.
详细描述
Background Information & Rationale
The management of type 1 diabetes (T1D) is rapidly evolving to offer technology that aims to improve metabolic control and decrease the burden of diabetes management. Hybrid-closed loop systems are at the forefront of this technology. They are comprised of an insulin pump and continuous glucose monitoring (CGM) system that interface in order to automatically adjust the delivery of basal insulin through the pump, based on CGM data. Insulin boluses for meals and snacks must still be entered manually by the user.
Studies of hybrid closed loop systems have primarily focused on clinical trials that show improved glycemic outcomes.1-3 Few studies have assessed real-world glycemic outcomes or patient-reported outcomes, and none have focused on a pediatric population.
A recent study published by Pinsker et al.4 showed improvement in psychosocial outcomes and persistent achievement of glycemic targets in a real-world setting in adults with T1D using the Tandem t:slim X2 pump with Control-IQ technology.
The Tandem t:slim X2 pump with Control-IQ is a hybrid closed loop system (using Dexcom G6 CGM) that has recently been approved for use by Health Canada, but has been used in the U.S. for the last year. This new technology will launch in Canada in March 2021, at which time existing Tandem t:slim X2 insulin pump users (with concurrent CGM use) will be able to upgrade their insulin pump software to access this technology (following review of an online module).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of T1D
- •Age 6-18 years
- •Currently using the Tandem t:slim X2 insulin pump with Dexcom G6 CGM, who are initiating Control-IQ
排除标准
- •Patients under the age of 6 years of age
- •Patients who are not English or French speaking
- •Patients unwilling to provide consent (assent where applicable).
结局指标
主要结局
INsulin delivery Systems: Perceptions, Ideas, Reflections and Expectations Questionnaire Post Intervention (Youth and Parent Versions)
时间窗: 16 weeks
Measures perceptions of the impact of automated insulin delivery systems on users' psychosocial functioning and quality of life. Score 0-100- mean score is significantly larger than 60 (out of 100). A score of greater than 60 indicates a perceived benefit of Control-IQ on psychosocial functioning and quality of life.
次要结局
- % time in target range 3.9-10.0 mmol/L (overall, day,and night)(0, 4, 8, 12, and 16 weeks)
- % time above target range >13.9mmol/L (overall, day, and night)(0, 4, 8, 12, and 16 weeks)
- Hypoglycemia Fear Survey (child and parent version)(Baseline and 16 weeks)
- % time below target range <3.0mmol/L (overall, day, and night)(0, 4, 8, 12, and 16 weeks)
- % time below target range <3.9mmol/L (overall, day, and night)(0, 4, 8, 12, and 16 weeks)
- Coefficient of variation (%)(0, 4, 8, 12, and 16 weeks)
- Estimated HbA1c (%)(0, 4, 8, 12, and 16 weeks)
- The World Health Organisation- Five Well-Being Index(Baseline and 16 weeks)
- % time above target range >10mmol/L (overall, day, and night)(0, 4, 8, 12, and 16 weeks)
- Change in Diabetes Impact and Device Satisfaction scale(Baseline and 16 weeks)
- Average glucose and standard deviation (mmol/L)(0, 4, 8, 12, and 16 weeks)
研究者
Caroline Zuijdwijk
Pediatric Endrocinologist, MD FRCPC
Children's Hospital of Eastern Ontario