Changeflow GovPing Pharma & Drug Safety Early automated insulin delivery pilot for newl...
Routine Notice Added Final

Early automated insulin delivery pilot for newly diagnosed T1D

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Detected March 31st, 2026
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Summary

ClinicalTrials.gov registered a new pilot study (NCT07501338) evaluating early implementation of automated insulin delivery systems in patients newly diagnosed with Type 1 Diabetes. The single-arm feasibility study will assess glycemic outcomes and device usability in approximately 20 participants. Registration satisfies federal requirements for applicable clinical trials under FDAAA 801.

What changed

ClinicalTrials.gov recorded a new clinical trial registration (NCT07501338) for a pilot study examining early automated insulin delivery (AID) technology in newly diagnosed Type 1 Diabetes patients. The study is designed as a single-arm feasibility trial to evaluate glycemic control outcomes and user experience with AID systems initiated shortly after diagnosis. Estimated enrollment is 20 participants with a primary completion timeframe of approximately 2 years.\n\nThis is a routine clinical trial registration notice with no new regulatory obligations. Trial sponsors and clinical investigators involved in diabetes device research should ensure their ongoing studies remain properly registered and updated on ClinicalTrials.gov in accordance with FDAAA 801 requirements. No compliance actions are required from this registration notice.

Source document (simplified)

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Named provisions

Study Design Eligibility Criteria Outcome Measures Interventions

Source

Analysis generated by AI. Source diff and links are from the original.

Classification

Agency
NLM
Instrument
Notice
Legal weight
Non-binding
Stage
Final
Change scope
Minor
Document ID
NCT07501338

Who this affects

Applies to
Healthcare providers Patients Clinical investigators
Industry sector
6211 Healthcare Providers
Activity scope
Clinical Trial Registration
Geographic scope
United States US

Taxonomy

Primary area
Healthcare
Operational domain
Clinical Operations
Topics
Medical Devices Pharmaceuticals

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