Effect of Continuous Glucose Monitoring Following Hospital Discharge of Patients With Type 2 Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 108
- 试验地点
- 2
- 主要终点
- Change in TIR 70-180 mg/dl
研究概览
简要总结
In this 12-week prospective observational cohort study, hospitalized insulin-requiring patients with T2D will receive a Dexcom continuous glucose monitor (CGM) to wear post-hospital discharge. Patients will complete surveys assessing patient-reported outcomes prior to CGM use and following completion of the study. CGM data will be captured by the patient smartphone app and analyzed. Patients will receive personalized CGM targets and alerts for hyperglycemia and hypoglycemia. Customized reports/ decision support will be sent to the usual diabetes provider. The initial observational cohort study design will be followed by an extension phase of 12 weeks in which data on continuation of use and glucose control will be collected but no further reports will be communicated to providers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Type 2 Diabetes
- •Basal insulin use >10 units per day
- •Hemoglobin A1c >8.0%
- •Smartphone compatible with Clarity App
- •Age ≥18 years
排除标准
- •Type 1 DM
- •Inability to consent
- •Pregnancy
- •Prisoners
- •Discharge to skilled nursing facility
研究组 & 干预措施
Dexcom CGM
干预措施: DexCom G6 (Device)
结局指标
主要结局
Change in TIR 70-180 mg/dl
时间窗: 12 weeks
Change in %time in range between 70-180 mg/dl from 2 weeks to 12 weeks.
% Wear Time >70%
时间窗: 12 weeks
The number of participants with % wear time \>70% will be reported.
DTSQc Score
时间窗: 12 weeks
The DTSQc compares the experience of the current treatment with the experience of the treatment before initiation of the study. Scores range from +3 ("much more satisfied now") to -3 ("much less satisfied now"), with 0 (midpoint) representing no change. Higher scores on the DTSQ total score indicate higher treatment satisfaction, and lower scores indicate lower treatment satisfaction. The total score ranges from -18 (maximum deterioration in satisfaction) to +18 (maximum improvement in satisfaction).A score of 0 indicates no change in satisfaction.
次要结局
未报告次要终点
研究者
Kathleen Dungan
Professor
Ohio State University