An interventional study of AIDANET and AIDANET in Type 1 Diabetes, sponsored by Marc Breton. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2025-08-14.
Sponsored by Marc Breton · Not applicable, Interventional, and Treatment
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).
The study will be performed for about 36 hours at a local hotel. Following the hotel session, participants will undergo a 7 day/6-night Remote Monitored At-Home use session. A one-week control period gathering data on glycemic control and insulin administration with the participants usual care therapy will also be completed. Participants will be randomized 1:1, to either Group A (control period prior to AIDANET use) or Group B (control period after AIDANET use).
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's enrollment of 8 is below the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →Marc Breton is the lead sponsor of 6 studies on the registry; none are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 5 (100%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will complete 7 days/6 nights at home usual care period using their personal equipment. Participants will then use the AIDANET system during a 3 days/2 nights hotel admission. Participants will continue to use the AIDANET system at home for 7 days/6 nights.
Device: AIDANET
Participants will use AIDANET system during a 3 days/2 nights hotel admission. Participants will continue to use the AIDANET system at home for 7 days/6 nights and then will complete 7 days/6 nights at home usual care period using their personal equipment.
Device: AIDANET
AIDANET is a fully automated, utilizing a Bolus Priming System (BPS) that recognizes meal ingestion and delivers a quick priming dose of insulin prior to extreme blood sugar excursions.
Also known as: Group B
AIDANET is a fully automated, utilizing a Bolus Priming System (BPS) that recognizes meal ingestion and delivers a quick priming dose of insulin prior to extreme blood sugar excursions.
Also known as: Group A
Change in the Mean Continuous Glucose Monitor (CGM) Between the Week of the Usual Care Observational Period and the Week of AIDANET At-Home.
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.
Time frame: 2 weeks
Difference in Percent Time-in-range
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.
Time frame: 2 weeks
Difference in Percent Time-below-range
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.
Time frame: 2 weeks
Difference in Percent Time-in-tight-range
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.
Time frame: 2 weeks
| Milestone | Usual Care→AIDANET | AIDANET→Usual Care |
|---|---|---|
| Started | 4 | 3 |
| Completed | 4 | 2 |
| Not completed | 0 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 |
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.
| miligrams per deciliter | Usual Care→AIDANET | AIDANET→Usual Care |
|---|---|---|
| Change in the Mean Continuous Glucose Monitor (CGM) Between the Week of the Usual Care Observational Period and the Week of AIDANET At-Home. | -6.8 ± 15.1 | -2.1 ± 20.7 |
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.
| percentage of time-in-range | Usual Care→AIDANET | AIDANET→Usual Care |
|---|---|---|
| Difference in Percent Time-in-range | 1.55 ± 4.34 | 2.76 ± 10.6 |
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.
| percentage of time-below-range | Usual Care→AIDANET | AIDANET→Usual Care |
|---|---|---|
| Difference in Percent Time-below-range | 0.93 ± 2.10 | 0.06 ± 0.45 |
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.
| percentage of time-in-tight-range | Usual Care→AIDANET | AIDANET→Usual Care |
|---|---|---|
| Difference in Percent Time-in-tight-range | 1.69 ± 10.71 | 4.01 ± 7.19 |
Collected over 24 days. Three days of hotel use with AIDANET followed by 7 days of AIDANET use at home, and 14 days of Usual Care. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Usual Care→AIDANET | 0/4 (0%) | 0/4 (0%) | 0/4 (0%) |
| AIDANET→Usual Care | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
One subject withdrew prior to study intervention. Results were only analyzed for subjects who started data collection.
| Age, Categorical(Participants) | Usual Care→AIDANET | AIDANET→Usual Care | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 4 | 2 | 6 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Usual Care→AIDANET | AIDANET→Usual Care | Total |
|---|---|---|---|
| Mean | 42.2 ± 6.5 | 36.5 ± 8.5 | 40.3 ± 7.7 |
| Sex: Female, Male(Participants) | Usual Care→AIDANET | AIDANET→Usual Care | Total |
|---|---|---|---|
| Female | 2 | 1 | 3 |
| Male | 2 | 1 | 3 |
| Ethnicity (NIH/OMB)(Participants) | Usual Care→AIDANET | AIDANET→Usual Care | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 4 | 2 | 6 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Usual Care→AIDANET | AIDANET→Usual Care | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 0 | 0 |
| White | 4 | 2 | 6 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Usual Care→AIDANET | AIDANET→Usual Care | Total |
|---|---|---|---|
| United States | 4 | 2 | 6 |
| Percentage of HbA1c (%)(percentage) | Usual Care→AIDANET | AIDANET→Usual Care | Total |
|---|---|---|---|
| Mean | 7.1 ± 0.5 | 7.3 ± 0.1 | 7.17 ± 0.41 |
| Weight (kg)(kilograms) | Usual Care→AIDANET | AIDANET→Usual Care | Total |
|---|---|---|---|
| Mean | 81.3 ± 17.5 | 87.5 ± 0.5 | 83.4 ± 14.6 |
4 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: Yes — Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals in the scientific community.
Supporting information: Study protocol, Sap, Icf
This study is completed, as verified in Jul 2025. You cannot join it, but the record below documents what was studied.
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Marc Breton