Get In Touch Phase 2 - Evaluating a Diabetes Care Support Program Facilitated by Cellular-enabled Glucose Meters, a Randomized Crossover Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 主要终点
- Change in HbA1c
研究概览
简要总结
The objective of the Get In Touch - Phase 2 (GIT-2) study was to evaluate a diabetes care support intervention facilitated by cellular-enabled glucose meters in adults with persistent poor control of type 2 diabetes.
详细描述
A 2-group randomized crossover trial comparing usual care to a diabetes care support intervention among patients with repeated HbA1c recordings greater than 8.0 percent during the previous 12 months. The intervention included 6 months of enrollment in Livongo for Diabetes, a Certified Diabetes Educator (CDE) based remote diabetes monitoring program facilitated by cellular-enabled glucose meters, with additional remote monitoring by their usual care team. HbA1c levels were recorded at enrollment and 3, 6, 9, and 12 months post enrollment. Questionnaire data were collected at baseline, 6 months, and 12 months post enrollment. Primary outcomes evaluated were change in HbA1c and treatment satisfaction at the 6 month endpoint with secondary outcomes of change in HbA1c and treatment satisfaction at the 12 month endpoint.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •speak English, having type 2 diabetes with two consecutive HbA1c recordings greater than 8.0% over the previous 12 months at the time of recruitment
排除标准
- •excluded if they were cognitively impaired, pregnant, or prisoners.
研究组 & 干预措施
Intervention First
Participants in Intervention First were enrolled in the intervention for the first 6 months of study participation followed by a return to usual care for the following 6 months. The intervention included provision of a cellular-enable glucose meter and enrollment in the Livongo for Diabetes support program that provided both in-the-moment and scheduled support, both provided by Livongo Health Inc.
干预措施: Livongo for Diabetes program (Other)
Intervention Second
Participants in the 'Intervention Second" received usual care for the first 6 months of study participation followed by enrollment in the intervention for the following 6 months. The intervention included provision of a cellular-enable glucose meter and enrollment in the Livongo for Diabetes support program that provided both in-the-moment and scheduled support, both provided by Livongo Health Inc.
干预措施: Livongo for Diabetes program (Other)
结局指标
主要结局
Change in HbA1c
时间窗: During 6-month enrollment in Intervention
The primary physiological outcome of this study was change in HbA1c during enrollment in the intervention compared to change while receiving usual care.
次要结局
- Change in Treatment Satisfaction(During 6-month enrollment in intervention)
研究者
Daniel Amante
Program Director
University of Massachusetts, Worcester