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

Evaluating a Digital Intervention for Alleviating Diabetes-specific Emotional Distress in Adults Living With Type 2 Diabetes Mellitus: Randomized Controlled Trial

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus, Type 2; Endocrine System Diseases; Metabolic Disease; Glucose Metabolism Disorders (Including Diabetes Mellitus)
• Intervention / Treatment: Behavioral: covivio

• Study Type: Interventional
• Enrollment (Estimated): 250
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Gitta A Jacob, PhD; Phone Number: +49 40 349930-374; Email: gitta.jacob@gaia-group.com
• Study Contact Backup: Name: Katharina M Rischer, PhD; Email: katharina.rischer@gaia-group.com

Study Locations

• Germany
  • Hamburg, Germany, 22085
    • Recruiting
    • GAIA AG
    • Contact: Gitta A Jacob, PhD
    • Contact: Katharina M Rischer, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Behavioral: covivio; Participants will receive access to the digital health intervention covivio in addition to TAU.
No Intervention: Control; No Intervention: TAU Participants allocated to the control group will receive access to treatment as usual (TAU).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	3 months
Diet self-management skills	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).	3 months; 6 months
Exercise self-management skills	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).	3 months; 6 months
Health-related quality of life	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).	3 months; 6 months
Body mass index (BMI)	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.	3 months; 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time in range (TIR) derived from CGM	Defined as time spent in the target range between 70 and 180 mg/dL. TIR will be assessed in hours and minutes for a 7-day period, and also expressed as percent.	6 months
Mean sensor glucose derived from CGM	Mean sensor glucose will be calculated over the 7 days of glucose measurements.	6 months
Coefficient of variation derived from CGM	The coefficient of variation will be used to quantify glycemic variability.	6 months

Collaborators and Investigators

• Sponsor: Gaia AG
• Collaborators: University Hospital Schleswig-Holstein; Philipps University Marburg Medical Center
• Investigators: Principal Investigator: Kamila Jauch-Chara, Dr. med., Zentrum für Integrative Psychiatrie, Universitätsklinikum Schleswig-Holstein

Study record dates

Study Major Dates

• Study Start (Actual): October 9, 2024
• Primary Completion (Estimated): April 9, 2026
• Study Completion (Estimated): April 9, 2026

Study Registration Dates

• First Submitted: July 26, 2024
• First Submitted That Met QC Criteria: July 26, 2024
• First Posted (Actual): July 31, 2024

Study Record Updates

• Last Update Posted (Estimated): November 8, 2024
• Last Update Submitted That Met QC Criteria: November 6, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: type 2 diabetes; covivio; diabetes self-management; digital health application
• Additional Relevant MeSH Terms: Diabetes Mellitus, Type 2; Diabetes Mellitus; Metabolic Diseases; Glucose Metabolism Disorders; Endocrine System Diseases
• Other Study ID Numbers: covivio RCT 2024

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No