Can a smartphone app lift the emotional burden of type 2 diabetes?
NCT ID NCT06529965
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a self-guided digital program called covivio to help adults with type 2 diabetes manage emotional distress tied to their condition. About 250 participants will either use the app alongside their usual care or continue with usual care alone. The goal is to see if the app reduces diabetes-specific stress and improves blood sugar control over six months.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 250 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Oct 2024
- Expected to finish
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Dec 2026
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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GAIA AG
Hamburg, 22085, Germany
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Other studies related to the condition(s) this trial covers.
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