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NCT03216460
Insulet Artificial Pancreas Free-Living IDE3
NA trial testing Insulet automated glucose control system in Type1 Diabetes Mellitus in 120 participants. Completed in 28 May 2019.
28 May 2019
Quick facts
| Lead sponsor | Insulet Corporation |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | device feasibility |
| Enrollment | 120 |
| Start date | 4 February 2019 |
| Primary completion | 28 May 2019 |
| Estimated completion | 28 May 2019 |
| Sites | 3 locations across United States |
Drugs / interventions tested
- Insulet automated glucose control system
Conditions studied
- Type1 Diabetes Mellitus — all drugs for Type1 Diabetes Mellitus →
Sponsor
Insulet Corporation — full company profile →
Who can join
Adults 2 to 85, any sex, with Type1 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Subjects will undergo a 7±1 day outpatient, standard therapy phase during which sensor and insulin data will be collected. Subjects or their caregivers will manage their diabetes at home per their usual routine using the study CGM and remain on current MDI or pump therapy. This will be followed by a 5-day/4-night or from approximately 48 to 72 hours for children ages 2.0-5.9 years, hybrid closed-loop phase conducted in a supervised hotel/rental house setting.
Publications & conference data
3 peer-reviewed publications reference this trial (live from Europe PMC):
-
Safety and Performance of the Omnipod Hybrid Closed-Loop System in Adults, Adolescents, and Children with Type 1 Diabetes Over 5 Days Under Free-Living Conditions.
Sherr JL, Buckingham BA, Forlenza GP, Galderisi A, et al · · 2020 · cited 66× · PMID 31596130 · DOI 10.1089/dia.2019.0286 -
Novel Bluetooth-Enabled Tubeless Insulin Pump: Innovating Pump Therapy for Patients in the Digital Age.
Ly TT, Layne JE, Huyett LM, Nazzaro D, et al · · 2019 · cited 25× · PMID 30239214 · DOI 10.1177/1932296818798836 -
Closing the Loop on Managing Youth With Type 1 Diabetes: Children Are Not Just Small Adults.
Sherr JL. · · 2018 · cited 19× · PMID 29936422 · DOI 10.2337/dci18-0003
Verify or expand the search:
- PubMed search for NCT03216460
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Type1 Diabetes Mellitus
Currently open trials in the same condition.
- NCT03945747 — MEtabolic and Renal Effects of AutoMAted Insulin Delivery Systems in Youth With Type 1 Diabetes Mellitus · active not recruiting
- NCT03369821 — EXtremely Early-onset Type 1 Diabetes EXtremely Early-onset Type 1 Diabetes (A Musketeers' Memorandum Study) · recruiting
- NCT03811470 — China Diabetes Registry by Metabolic Management Center · recruiting
Other Insulet Corporation trials
Trials by the same sponsor.
- NCT07521475 — Evaluation of the Fully Closed Loop Omnipod® System in Type 2 Diabetes · NA · not yet recruiting
- NCT07276776 — An Evaluation of the Omnipod® M System in Adults With Type 2 Diabetes · NA · active not recruiting
- NCT07070830 — Simplified Onboarding in Adults With Type 2 Diabetes · NA · completed
- NCT06865989 — Omnipod® SmartAdjust 2.0 System Compared to the Omnipod® 5 System in Individuals With Type 1 or Type 2 Diabetes · NA · completed
- NCT06547918 — SmartAdjust 2.0 System With Type 1 and Type 2 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 NCT03216460 (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 Insulet Corporation
- Last refreshed: 2 August 2019
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/NCT03216460.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing