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NCT06633965: MiniNET

Safety and Feasibility Testing of a Smaller Network Version of AIDANET

Completed NA Results posted Last updated 14 August 2025
What this trial tests

NA trial testing AIDANET in Type 1 Diabetes in 8 participants. Completed in 18 December 2024.

Timeline
20 November 2024
Primary endpoint
16 December 2024
18 December 2024

Quick facts

Lead sponsorMarc Breton
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designcrossover
Maskingnone
Primary purposetreatment
Enrollment8
Start date20 November 2024
Primary completion16 December 2024
Estimated completion18 December 2024
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Marc Breton

Who can join

Adults 18 to 60, any sex, with Type 1 Diabetes. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in the Mean Continuous Glucose Monitor (CGM) Between the Week of the Usual Care Observational Period and the Week of AIDANET At-Home. Primary · 2 weeks

This study represents a small pilot study to assess the safety and efficacy of the small-version AIDANET system and is not formally powered. Nevertheless, the randomized crossover design will allow for analysis of period effects between Group A and Group B. Comparison between these groups will be made to determine if a period effect can explain part of the benefit of the FCL system during the at-home period.

GroupValue95% CI
Usual Care→AIDANET-6.8± 15.1
AIDANET→Usual Care-2.1± 20.7
Difference in Percent Time-in-range Secondary · 2 weeks

Difference in percent CGM samples in 70-180 mg/dL between the Week of the Usual Care Observational Period and the Week of AIDANET At-home. Represented as AIDANET minus Usual Care.

GroupValue95% CI
Usual Care→AIDANET1.55± 4.34
AIDANET→Usual Care2.76± 10.6
Difference in Percent Time-below-range Secondary · 2 weeks

Difference in CGM percent samples \< 70mg/dL between the Week of the Usual Care Observational Period and the Week of AIDANET At-home. Represented as AIDANET minus Usual Care.

GroupValue95% CI
Usual Care→AIDANET0.93± 2.10
AIDANET→Usual Care0.06± 0.45
Difference in Percent Time-in-tight-range Secondary · 2 weeks

Difference in percent CGM samples in 70-140 mg/dL between the Week of the Usual Care Observational Period and the Week of AIDANET At-home. Represented as AIDANET minus Usual Care.

GroupValue95% CI
Usual Care→AIDANET1.69± 10.71
AIDANET→Usual Care4.01± 7.19

Sponsor's own description

A randomized 1:1 crossover trial that intends to demonstrate feasibility and safety of the Automated Insulin Delivery as Adaptive NETwork (AIDANET) system run in a new smaller network version, used in full closed loop (FCL) by adults who have been diagnosed with type 1 diabetes (T1D).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Research Gaps, Challenges, and Opportunities in Automated Insulin Delivery Systems.
    Jacobs PG, Levy CJ, Brown SA, Riddell MC, et al · · 2025 · cited 2× · PMID 40590464 · DOI 10.1177/19322968251338754
  2. Miniaturized Neural Networks for Deploying Fully Closed Loop Insulin Delivery Systems: A Pilot Study Featuring Flexible Meal Announcement Options.
    Pryor EC, Moscoso-Vasquez M, Fulkerson D, Holmes V, et al · · 2025 · cited 1× · PMID 40781999 · DOI 10.1177/19322968251364283

Verify or expand the search:

Other recruiting trials for Type 1 Diabetes

Currently open trials in the same condition.

Other Marc Breton trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT06633965.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing