Changes in Person-reported Outcomes and Behavior Due to a Predictive Algorithm: A Pre-post Trial With the Accu-Chek SmartGuide CGM and the Predict App Solution
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 89
- 试验地点
- 1
- 主要终点
- Fear of hypoglycemia (HFS-II)
研究概览
简要总结
The goal of this controlled pre-post-trial is to test the Accu-Chek SmartGuide continuous glucose monitoring (CGM) system and whether its predictive features provide additional benefits for adults with type 1 diabetes or insulin- treated type 2 diabetes.
The main questions this study aims to answer are:
- Does using the Accu-Chek SmartGuide together with the Predict App change participants' fear of hypoglycemia?
- Does the Predict App affect other psychological and behavioral outcomes, such as sleep quality, confidence in preventing hypoglycemia, diabetes- related distress, and diabetes empowerment?
- Does the use of the predictive features affect glucose levels and the way participants use and respond to CGM alarms and trend information?
Participants will use the Accu-Chek SmartGuide for 6 weeks. During the first 2 weeks, participants will use the CGM system without the predictive features. During the following 4 weeks, participants will use the system together with the Accu-Chek SmartGuide Predict App. Participants will complete online questionnaires at two time points (after 2 and after 6 weeks) and answer short questions twice a day through a smartphone app during the first 2 weeks and the last 2 weeks of the study. CGM data will be collected throughout the study. A subgroup of 10 participants will also be invited to take part in an online interview about their experiences with the predictive features.
详细描述
Continuous glucose monitoring (CGM) is widely used by people with insulin- treated diabetes to monitor glucose levels and support daily diabetes management. The Accu-Chek SmartGuide CGM system provides continuous glucose measurements and includes predictive features that are intended to provide information about possible future glucose trends.
This study will investigate the use of the Accu-Chek SmartGuide with and without these predictive features in adults with type 1 diabetes or type 2 diabetes treated with intensified insulin therapy. The study will be conducted remotely in Germany through the dia*link online panel. No in-person study visits are planned.
Participants will use the Accu-Chek SmartGuide CGM system for a total of 6 weeks. The study consists of two consecutive phases. During the first 2 weeks, participants will use the Accu-Chek SmartGuide CGM without the Predict App and therefore without the predictive features. This phase provides a period in which CGM data and self-reported outcomes can be assessed before the predictive features are introduced. After 2 weeks, participants will receive training on the Predict App and begin a 4-week period using the Accu-Chek SmartGuide together with the Predict App.
Participants will complete online questionnaires at the end of the first 2 weeks and at the end of the 6-week study period. The questionnaires assess fear of hypoglycemia, sleep quality, confidence in preventing hypoglycemia, diabetes- related distress, and diabetes empowerment.
During the first 2 weeks and the last 2 weeks of the study, participants will also complete short ecological momentary assessment (EMA) questionnaires twice daily using a smartphone app. The morning assessment asks about sleep quality and confidence in preventing hypoglycemia. The evening assessment asks about the use and evaluation of CGM functions, including trend arrows, alarms, and predictive features. Participants will also be asked about possible therapy adjustments, satisfaction with the CGM functions, and diabetes- related distress, including distress related to hypoglycemia, hyperglycemia, and glucose variability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 1 diabetes or Type 2 diabetes with intensified insulin therapy (defined as basal-bolus therapy with self-adjustment of bolus doses)
- •CGM use during the past 3 months (without predictive features)
- •Age ≥ 18 years
- •HbA1c < 10%
- •Informed consent
排除标准
- •Use of the SmartGuide CGM solution
- •Current treatment with psychiatric medications
- •Diabetes duration < 3 months
- •Current or planned pregnancy
- •Peripheral neuropathy that will impact sleep quality according to the judgement of the participant
- •Severe complications (e.g. kidney disease, cancer)
研究组 & 干预措施
SmartGuide CGM without Predict App
干预措施: SmartGuide CGM without Predict App (Device)
SmartGuide CGM with Predict App
干预措施: SmartGuide CGM with Predict App (Device)
结局指标
主要结局
Fear of hypoglycemia (HFS-II)
时间窗: At baseline (after 2 weeks from enrollment) and at follow-up (after 4 weeks from baseline)
Within-person change in fear of hypoglycemia from baseline to follow-up, assessed via the Hypoglycemia-Fear Survey II questionnaire
次要结局
- Overall sleep quality (PSQI)(At baseline (after 2 weeks from enrollment) and at follow-up (after 4 weeks from baseline))
- Hypoglycemia confidence (HCS)(At baseline (after 2 weeks from enrollment) and at follow-up (after 4 weeks from baseline))
- Diabetes distress (DDS)(At baseline (after 2 weeks from enrollment) and at follow-up (after 4 weeks from baseline))
- Diabetes Empowerment (DES-SF)(At baseline (after 2 weeks from enrollment) and at follow-up (after 4 weeks from baseline))
- Daily sleep quality(14 days after enrollment and 14 days before study end with two prompts per day (morning & evening))
- Avoidance of hypos(14 days after enrollment and 14 days before study end with two prompts per day (morning & evening))
- Time with diabetes and glycemic-specific distress(14 days after enrollment and 14 days before study end with two prompts per day (morning & evening))
- Changes in behavior(14 days after enrollment and 14 days before study end with two prompts per day (morning & evening))
- Changes in glycemic outcomes(From enrollment to the end of the study at 6 weeks)
- Personal experiences(After the study period of 6 weeks)
研究者
Dominic Ehrmann
Prof. Dr.
FIDAM RDC