Clinical trial NCT06529965: Evaluating a Digital Intervention for Alleviating Diabetes-specific Emotional Distress in Adults Living With T2DM
Official title: Evaluating a Digital Intervention for Alleviating Diabetes-specific Emotional Distress in Adults Living With Type 2 Diabetes Mellitus: Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Glucose Metabolism Disorders (Including Diabetes Mellitus)
Metabolic Disease
Endocrine System Diseases
Diabetes Mellitus, Type 2
Keywords: type 2 diabetes
covivio
diabetes self-management
digital health application
Lead sponsor: Gaia AG
Sponsor class: INDUSTRY
Collaborators: name: University Hospital Schleswig-Holstein
name: Philipps University Marburg
First posted: 2024-07-31
Enrollment: 250
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: randomized controlled trial with two arms: (i) online intervention in addition to treatment-as-usual versus (ii) treatment-as-usual
Primary purpose: TREATMENT

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.


Eligibility criteria: 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)

Primary outcomes:
measure: Diabetes-specific emotional distress
timeFrame: 6 months
measure: Glucose management indicator
timeFrame: 6 months
Secondary outcomes:
measure: Diabetes-specific emotional distress
timeFrame: 3 months
measure: Diet self-management skills
timeFrame: 3 months; 6 months
measure: Exercise self-management skills
timeFrame: 3 months; 6 months
measure: Health-related quality of life
timeFrame: 3 months; 6 months
measure: Body mass index (BMI)
timeFrame: 3 months; 6 months
Other outcomes:
measure: Time in range (TIR) derived from CGM
timeFrame: 6 months
measure: Mean sensor glucose derived from CGM
timeFrame: 6 months
measure: Coefficient of variation derived from CGM
timeFrame: 6 months
Locations:
city: Hamburg
country: Germany
facility: GAIA AG
Study officials:
affiliation: Zentrum für Integrative Psychiatrie, Universitätsklinikum Schleswig-Holstein
name: Kamila Jauch-Chara, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: