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NCT Number: NCT06529965

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

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.

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Key information

Conditions

Glucose Metabolism Disorders (Including Diabetes Mellitus) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Disease Metabolic Diseases Nutritional and Metabolic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GAIA AG

Hamburg, 22085, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

covivio

Behavioral

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

Primary outcomes

  1. Diabetes-specific emotional distress

    Time frame: 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).

  2. Glucose management indicator

    Time frame: 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 outcomes

  1. Diabetes-specific emotional distress

    Time frame: 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).

  2. Diet self-management skills

    Time frame: 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).

  3. Exercise self-management skills

    Time frame: 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).

  4. Health-related quality of life

    Time frame: 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).

  5. Body mass index (BMI)

    Time frame: 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.

Other outcomes

  1. Time in range (TIR) derived from CGM

    Time frame: 6 months

    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.

  2. Mean sensor glucose derived from CGM

    Time frame: 6 months

    Mean sensor glucose will be calculated over the 7 days of glucose measurements.

  3. Coefficient of variation derived from CGM

    Time frame: 6 months

    The coefficient of variation will be used to quantify glycemic variability.

Sponsors and collaborators

Lead sponsor

Gaia AG

Industry

Collaborators

  • Philipps University Marburg
  • University Hospital Schleswig-Holstein

Registry information

Official study title

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

Acronym: EASE-T2DM

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 31, 2024
Registry last updated
Jun 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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