Evaluating a Digital Intervention for Alleviating Diabetes-specific Emotional Distress in Adults Living With Type 2 Diabetes Mellitus: Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- Gaia AG
- 入组人数
- 250
- 试验地点
- 1
- 主要终点
- Glucose management indicator
研究概览
简要总结
This randomized controlled trial (RCT) with 250 patients suffering from type 2 diabetes mellitus (T2DM) aims to investigate the effectiveness of the self-guided digital therapeutic covivio. Inclusion criteria are: male, female or non-binary; age ≥ 18 years; confirmed diagnosis of T2DM; elevated levels of diabetes-specific emotional distress (Problem Areas in Diabetes [PAID]-20 score ≥ 33); consent to participate; sufficient German language skills. Exclusion criteria are: a diagnosis of type 1 diabetes mellitus (T1DM); current use of continuous glucose monitoring (CGM) as part of one's diabetes treatment; changes or planned changes in medication within 4 weeks before the baseline visit or in the subsequent 6 months; a bariatric operation within 4 weeks before the baseline visit or such an operation planned in the subsequent 6 months; changes or planned changes in psychotherapeutic treatment within 4 weeks before the baseline visit or in the subsequent 6 months. In addition, participants will be excluded from the study if they did not wear the CGM sensor for at least 6 of 7 days at baseline (before randomization), providing a minimum of 96 hours of glucose values including at least 24 hours overnight.
Patients will be randomized and allocated in a 1:1 ratio to either an intervention group, in which they will receive access to covivio in addition to treatment as usual (TAU, n = 125), or to a control group, in which they will receive only TAU (n = 125).
Co-primary endpoints of this trial will be the between-groups difference in the PAID-20 total score in the intervention and control group at six months, adjusted for the PAID-20 baseline score as well as the glucose management indicator (estimated HbA1c) assessed using continuous glucose monitoring devices (for a period of 7 days) at six months, adjusted for the baseline score.
Secondary endpoints will be diabetes self-management skills, body mass index (BMI), and quality of life.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male, female or non-binary
- •age ≥ 18 years
- •diagnosis of T2DM secured via submission of a medical certificate attesting to the presence of at least one of the following ICD-10-GM diagnoses of T2DM: E11.20, E11.30, E11.40, E11.50, E11.60, E11.72, E11.74, E11.80, E11.90
- •elevated levels of diabetes-specific emotional distress: cut-off ≥ 33 on the PAID-20
- •access to CGM-compatible smartphone
- •consent to participate
- •sufficient knowledge of the German language
排除标准
- •diagnosis of type 1 diabetes mellitus (T1DM)
- •change in medication (type, frequency of use or dosage) within 4 weeks before the baseline visit or planned within the subsequent 6 months
- •recent or planned bariatric operation within 4 weeks before the baseline visit or within the subsequent 6 months
- •change in psychotherapeutic treatment within 4 weeks before the baseline visit or planned within the subsequent 6 months
- •current use of continuous glucose monitoring (CGM) as part of one's diabetes treatment
- •experiencing problems with the CGM sensor or insufficient CGM data quality at baseline (T0) (i.e., wearing the CGM sensor on less than 6 of 7 days, providing less than a minimum of 96 hours of glucose values, providing less than 24 hours overnight CGM data)
研究组 & 干预措施
Intervention/Treatment
Experimental: covivio + TAU
Participants allocated to the intervention group will receive access to covivio in addition to treatment as usual (TAU).
covivio is a digital health application designed for individuals with type 2 diabetes mellitus who suffer from elevated levels of diabetes-specific emotional distress, accessible through a web browser. The application focuses on treatment methods derived from cognitive behavioral therapy (CBT). Topics addressed by covivio are disease literacy, physical activity and exercise, nutrition, stress management, sleep management, mood problems, and social resources.
The program operates through interactive "dialogues", which are accompanied by illustrations, audio recordings, motivational text messages, worksheets, and summaries. Users are also encouraged to regularly complete short questionnaires to monitor their complaints. Once registered, the program remains accessible for 180 days.
干预措施: covivio (Behavioral)
Control
No Intervention: TAU
Participants allocated to the control group will receive access to treatment as usual (TAU).
结局指标
主要结局
Glucose management indicator
时间窗: 6 months
The glucose management indicator (GMI) is an estimation of HbA1c from CGM. It is calculated as follows: GMI (%) = 3.31 + 0.02392 x \[mean glucose in mg/dL\].
Diabetes-specific emotional distress
时间窗: 6 months
Assessed with the Problem Areas in Diabetes Questionnaire (PAID-20). Total score ranging from 0-100; higher scores indicate higher diabetes-specific emotional distress (worse outcome).
次要结局
- Diabetes-specific emotional distress(3 months)
- Diet self-management skills(3 months; 6 months)
- Exercise self-management skills(3 months; 6 months)
- Body mass index (BMI)(3 months; 6 months)
- Health-related quality of life(3 months; 6 months)