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NCT05973422: SigiFIH
Sigi Insulin Management System - A First-in-Human Study in Adults With Type 1 Diabetes
NA trial testing SIGI Insulin Management System in Type 1 Diabetes in 10 participants. Status unknown.
30 September 2024
Quick facts
| Lead sponsor | Tandem Diabetes Care, Inc. |
|---|---|
| Phase | NA |
| Status | Status unknown |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | device feasibility |
| Enrollment | 10 |
| Start date | 31 May 2024 |
| Primary completion | 30 September 2024 |
| Estimated completion | 30 September 2024 |
Drugs / interventions tested
- SIGI Insulin Management System
Conditions studied
- Type 1 Diabetes — all drugs for Type 1 Diabetes →
Sponsor
Tandem Diabetes Care, Inc.
Who can join
18 and older, any sex, with Type 1 Diabetes. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This early feasibility first-in-human study is a prospective single-arm single-center study of Sigi insulin patch pump. After a 1st day and night under medical surveillance during a hotel stay, Sigi system will be evaluated during 15 days at home in adults with type 1 diabetes.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT05973422
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Currently open trials in the same condition.
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- NCT07212179 — Safety and Feasibility of a Self-Learning Bolus Calculator With Simplified Meal Announcement in Adolescents With Type 1 · NA · recruiting
- NCT07287943 — To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes. · NA · recruiting
Other Tandem Diabetes Care, Inc. trials
Trials by the same sponsor.
- NCT07325461 — Feasibility Study of Extended Wear Insulin Infusion Set Options During Home Use in People With Type 1 Diabetes · NA · recruiting
- NCT06834568 — Tandem Freedom - Feasibility Trial 2 · NA · completed
- NCT06717451 — PS230005 Control-IQ 1.5 Post-Approval Study · active not recruiting
- NCT06428591 — Tandem Freedom Feasibility Study 1 · NA · completed
- NCT06273124 — Investigational Extended Wear Insulin Infusion Set in People With Type 1 Diabetes · 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 NCT05973422 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Tandem Diabetes Care, Inc.
- Last refreshed: 11 January 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/NCT05973422.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing