NCT05525117

Brief Summary

This trial was designed to evaluate the effectiveness of the dialogue-based online intervention covivio, which was designed to improve diabetes self-management in patients with type 2 diabetes. The study aims to test the hypothesis that covivio has a greater positive impact on glycemic control than treatment as usual. Patients with type 2 diabetes mellitus will be randomized and allocated to either an intervention group, receiving covivio in addition to treatment as usual, or a control group, which receives only treatment as usual. The primary endpoint is the HbA1c value six month after baseline.

Trial Health

30
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Jul 2023

Geographic Reach
1 country

1 active site

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 30, 2022

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 1, 2022

Completed
10 months until next milestone

Study Start

First participant enrolled

July 4, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 15, 2024

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2024

Completed
Last Updated

May 28, 2024

Status Verified

May 1, 2024

Enrollment Period

1 year

First QC Date

August 30, 2022

Last Update Submit

May 24, 2024

Conditions

Type 2 Diabetes

Keywords

type 2 diabetescoviviodiabetes self-managementdigital health application

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    The primary objective of this study is to determine whether the online intervention covivio will reduce HbA1c values in the intervention group compared to the control group.

    6 months

Secondary Outcomes (5)

  • Depressive symptoms

    6 months

  • Diabetes Self-management

    6 months

  • Body Mass Index

    6 months

  • Health-Related Quality of Life

    6 months

  • Proportion of patients achieving a reduction in HbA1c

    6 months

Other Outcomes (2)

  • Waist circumference

    6 months

  • systolic blood pressure

    6 months

Study Arms (2)

online intervention in addition to treatment-as-usual

EXPERIMENTAL

online intervention: covivio in addition to treatment as usual

Behavioral: covivio (additional to treatment as usual)

treatment-as-usual

OTHER

Other: treatment as usual

Other: treatment as usual

Interventions

covivio (additional to treatment as usual)BEHAVIORAL

Covivio is a dialogue-based online psychological intervention for patients with type 2 diabetes. This intervention includes elements that address disease literacy, physical activity and exercise, dieting and nutritional principles, coping with depression, etc. Content is adapted to users needs using interactive dialogues, illustrations and audio files. Participants may also continue with their usual treatment.

online intervention in addition to treatment-as-usual
treatment as usualOTHER

Participants may continue with any treatment that they require (treatment as usual)

treatment-as-usual

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • diagnosis of T2DM (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)
  • HbA1c value ≥ 7.0% (53 mmol/mol)
  • BMI ≥ 23 kg/m2
  • Consent to participate
  • Sufficient knowledge of the German language

You may not qualify if:

  • diagnosis of type 1 diabetes mellitus (T1DM)
  • change in medication, frequency of use or dosage (planned within 4 weeks before T0 or during the study period)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GAIA

Hamburg, 22085, Germany

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Gitta Jacob, PD PhD

    Gaia AG

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: randomized controlled trial with two arms: (i) online intervention in addition to treatment-as-usual versus (ii) treatment-as-usual
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2022

First Posted

September 1, 2022

Study Start

July 4, 2023

Primary Completion

July 15, 2024

Study Completion

December 15, 2024

Last Updated

May 28, 2024

Record last verified: 2024-05

Locations

DE(1)