Diabetes Mellitus, Type 2, Endocrine System Diseases, Glucose Metabolism Disorders (Including Diabetes Mellitus), Metabolic Disease
Conditions
Keywords
type 2 diabetes, covivio, diabetes self-management, digital health application
Brief summary
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.
Interventions
BEHAVIORALcovivio
Participants will receive access to the digital health intervention covivio in addition to TAU.
Sponsors
Gaia AG
University Hospital Schleswig-Holstein
Philipps University Marburg
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
randomized controlled trial with two arms: (i) online intervention in addition to treatment-as-usual versus (ii) treatment-as-usual
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes-specific emotional distress | 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 | 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 \[mean glucose in mg/dL\]. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Diabetes-specific emotional distress | 3 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). |
| Diet self-management skills | 3 months; 6 months | Assessed with the Diet Subscale of the Summary of Diabetes Self-Care Activities Measure (SDSCA). The diet subscale contains four items and the score may range from 0-28; higher scores indicate higher diet self-management skills (better outcome). |
| Exercise self-management skills | 3 months; 6 months | Assessed with the Exercise Subscale of the Summary of Diabetes Self-Care Activities (SDSCA). The exercise subscale contains two items and the score may range from 0-14; higher scores indicate higher exercise self-management skills (better outcome). |
| Health-related quality of life | 3 months; 6 months | Quantified with the Assessment of Quality of Life - 8 Dimensions (AQoL-8D). Total score ranging from 0-100; higher scores indicate a higher quality of life (better outcome). |
| Body mass index (BMI) | 3 months; 6 months | The BMI will be computed according to the following formula: kg/m2, where kg is a person's weight in kilograms and m2 is their height in meters squared. If necessary, height will be converted into meters and weight will be converted into kilograms. |
Countries
Germany
Contacts
PRINCIPAL_INVESTIGATORKamila Jauch-Chara, Dr. med.
Zentrum für Integrative Psychiatrie, Universitätsklinikum Schleswig-Holstein
Outcome results
None listed