Evaluating a Digital Intervention for Alleviating Diabetes-specific Emotional Distress in Adults Living With T2DM

NCT06529965 | Recruiting

• 1 other identifier: covivio RCT 2024
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (2)

• Diabetes-specific emotional distress

  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).

  6 months

• Glucose management indicator

  The glucose management indicator (GMI) is an estimation of HbA1c from CGM. It is calculated as follows: GMI (%) = 3.31 + 0.02392 x \[mean glucose in mg/dL\].

  6 months

Secondary Outcomes (5)

• Diabetes-specific emotional distress

  3 months

• Diet self-management skills

  3 months; 6 months

• Exercise self-management skills

  3 months; 6 months

• Health-related quality of life

  3 months; 6 months

• Body mass index (BMI)

  3 months; 6 months

Other Outcomes (3)

• Time in range (TIR) derived from CGM

  6 months

• Mean sensor glucose derived from CGM

  6 months

• Coefficient of variation derived from CGM

  6 months

Study Arms (2)

Intervention/Treatment

EXPERIMENTAL

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.

Behavioral: covivio

Control

NO INTERVENTION

No Intervention: TAU Participants allocated to the control group will receive access to treatment as usual (TAU).

Interventions

covivio BEHAVIORAL

Participants will receive access to the digital health intervention covivio in addition to TAU.

Intervention/Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Gaia AG: lead
• University Hospital Schleswig-Holstein: collaborator
• Philipps University Marburg: collaborator

Study Sites (1)

GAIA AG

Hamburg, 22085, Germany

RECRUITING

MeSH Terms

Conditions

Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases; Diabetes Mellitus

Study Officials

• Kamila Jauch-Chara, Dr. med.

  Zentrum für Integrative Psychiatrie, Universitätsklinikum Schleswig-Holstein

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gitta A Jacob, PhD

CONTACT

+49 40 349930-374; gitta.jacob@gaia-group.com

Katharina M Rischer, PhD

CONTACT

katharina.rischer@gaia-group.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: randomized controlled trial with two arms: (i) online intervention in addition to treatment-as-usual versus (ii) treatment-as-usual

Study Record Dates

• First Submitted: July 26, 2024
• First Posted: July 31, 2024
• Study Start: October 9, 2024
• Primary Completion: April 9, 2026
• Study Completion: April 9, 2026
• Last Updated: November 8, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)