Last reviewed · How we verify
NCT05525117: OnSeT-2D
Effectiveness of an Online Self-management Intervention for Type 2 Diabetes Mellitus
NA trial testing covivio (additional to treatment as usual) in Type 2 Diabetes. Withdrawn.
15 July 2024
Quick facts
| Lead sponsor | Gaia AG |
|---|---|
| Phase | NA |
| Status | Withdrawn |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Start date | 4 July 2023 |
| Primary completion | 15 July 2024 |
| Estimated completion | 15 December 2024 |
| Sites | 1 location across Germany |
Drugs / interventions tested
- covivio (additional to treatment as usual)
- treatment as usual
Conditions studied
- Type 2 Diabetes — all drugs for Type 2 Diabetes →
Sponsor
Gaia AG — full company profile →
Who can join
Adults 18 to 75, any sex, with Type 2 Diabetes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
-
Digital therapeutics in the clinic.
Phan P, Mitragotri S, Zhao Z. · · 2023 · cited 39× · PMID 37476062 · DOI 10.1002/btm2.10536
Verify or expand the search:
- PubMed search for NCT05525117
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Type 2 Diabetes
Currently open trials in the same condition.
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- NCT07272837 — Impact of Semaglutide (Ozempic/Wegovy®) on Heart and Muscle Mass · recruiting
- NCT07463859 — Effects of Periodontal Treatment Associated With Antimicrobial Photodynamic Therapy on Halitosis in Patients With Diabet · NA · recruiting
- NCT07254689 — The Food for Health Study · NA · recruiting
- NCT07558863 — Effect of GLP-1RA on Cardiac Autonomic Neuropathy in Type 2 Diabetes · Phase 4 · recruiting
Other Gaia AG trials
Trials by the same sponsor.
- NCT06529965 — Evaluating a Digital Intervention for Alleviating Diabetes-specific Emotional Distress in Adults Living With T2DM · NA · recruiting
- NCT06601907 — Researching the Effectiveness of a Alivis, a Digital Health Application for Borderline Personality Disorder · NA · terminated
- NCT06237166 — Evaluation of an Online Intervention for Female Sexual Dysfunction · NA · completed
- NCT06243978 — Effectiveness of a Digital Health Application for Primary Hypertension (Liebria) · NA · recruiting
- NCT06221930 — Researching the Effectiveness of Attexis, a Digital Health Application for Adults With Attention Deficit Hyperactivity D · NA · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05525117 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Gaia AG
- Last refreshed: 28 May 2024
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05525117.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing