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
- 2
- 主要终点
- Diabetes-specific emotional distress
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)
结局指标
主要结局
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).
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 \[mean glucose in mg/dL\].
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)