Fully Closed Loop System for Type 1 Diabetes

Not currently recruiting at 2 trial locations

Overseen By Lindsey Towers

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of Colorado, Denver

Must be taking: Insulin

Must not be taking: SGLT-2 inhibitors

Disqualifiers: Seizure disorder, Heart condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new system called AIDANET for managing Type 1 Diabetes. The research will explore how effectively this system controls blood sugar levels compared to usual care. Participants will be divided into two groups to assess the effects of using AIDANET before or after a control period. Individuals with Type 1 Diabetes who have used insulin and an insulin pump for at least six months might be suitable candidates, particularly if they are open to new diabetes management technology. As an unphased trial, this study offers a unique opportunity to contribute to innovative diabetes management research.

Do I have to stop taking my current medications for the trial?

The trial requires you to stop using any personal continuous glucose monitor (CGM) other than the Dexcom G6 during the study. You also cannot start any new non-insulin glucose-lowering medications during the trial, but you can continue using a stable dose of such medications if you've been on them for at least a month. If you're currently using an SGLT-2 or SGLT-1/2 inhibitor, you will need to stop due to safety concerns.

What prior data suggests that the AIDANET system is safe for use in managing Type 1 Diabetes?

Research has shown that the AIDANET system is generally safe for people with type 1 diabetes. In one study, six adults used AIDANET for a week without reporting major safety issues, suggesting its safety for short-term use. Another study examined children aged 6-13 to assess the system's safety, though specific results from this study are not provided.

Overall, while detailed information on side effects is lacking, the research supports AIDANET's safety. Participants in these studies did not experience serious problems, indicating the system may be safe for managing diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the AIDANET system because it offers a fully closed loop system for managing Type 1 Diabetes, unlike traditional options that often require manual adjustments of insulin doses. This system automatically monitors glucose levels and adjusts insulin delivery in real-time, reducing the burden on patients to constantly monitor their blood sugar. By automating this process, AIDANET aims to provide more stable blood glucose levels and improve the quality of life for those with Type 1 Diabetes. This innovation could potentially minimize the risk of long-term complications associated with the condition.

What evidence suggests that the AIDANET system is effective for Type 1 Diabetes?

Research shows that the AIDANET system can help people with Type 1 Diabetes manage their blood sugar levels. One study found that participants using AIDANET had an average blood sugar level of 161.3 mg/dL, compared to 168 mg/dL with their usual care. This system also increased the time when blood sugar levels stayed within the healthy range of 70 to 180 mg/dL. In this trial, participants in Group A will have a two-week control period before using the AIDANET system, while those in Group B will have a two-week control period after using it. AIDANET uses AI technology to deliver insulin more effectively, simplifying diabetes management. Early results suggest it can help people with Type 1 Diabetes better control their blood sugar, making life a bit easier. ^{3 6 7 8 9}

Who Is on the Research Team?

Gregory P Forlenza, MD

Principal Investigator

University of Colorado Anschutz - Barbara Davis Center

Are You a Good Fit for This Trial?

This trial is for people aged 14-60 with Type 1 Diabetes, using an insulin pump and a Dexcom G6 CGM. They must have been diagnosed at least a year ago, not be pregnant or planning pregnancy, willing to use the study's FCL system and follow the protocol including hotel stays and remote monitoring.

Inclusion Criteria

Living with one or more parent/guardian or supportive companions knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff

Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial

Willingness to participate in all study procedures including the house/hotel session, exercise challenges (e.g., one hour per day during hotel), and to consume approximately 3 unannounced meals per day during the relevant portion of the supervised hotel session

Exclusion Criteria

Participant does not have a direct supervisor involved in the conduct of the trial

I am currently taking medication for diabetes that could increase my risk of a specific type of ketoacidosis.

I have a bleeding disorder such as hemophilia.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Control Period

Two-week control period gathering data on glycemic control and insulin administration with the participants' usual care therapy

2 weeks

Hotel Session

Participants stay at a local hotel/rental for 5 days and 4 nights for initial testing

5 days

Remote Monitored At-Home Use

Participants undergo a 7 day/6-night remote monitored at-home use session

1 week

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AIDANET system

Trial Overview The AIDANET system is being tested in this trial. Participants will either start with their usual care before switching to AIDANET or vice versa. The study includes a stay at a facility followed by home monitoring to compare glycemic control between usual care and the new system.

How Is the Trial Designed?

Group I: Group B Experimental Treatment 1 Intervention

Two-week control period after the use of the AIDANET system.

Group II: Group A Experimental Treatment 1 Intervention

Two-week control period before the use of the AIDANET system.

Who Is Running the Clinical Trial?

University of Colorado, Denver

Lead Sponsor

Trials

1,842

Recruited

3,028,000+

Gregory Forlenza

Lead Sponsor

Trials

1

Recruited

40+

University of Virginia

Collaborator

Trials

802

Recruited

1,342,000+

University of California, San Francisco

Collaborator

Trials

2,636

Recruited

19,080,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07039617

Study Details | NCT07039617 | AIDANET At Home Study A randomized cross-over trial assessing glycemic control on Automated insulin delivery as Adaptive Network (AIDANET) algorithm when used in three modes: ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12479459/

A Pilot Study Featuring Flexible Meal Announcement Options The mean glucose during usual care was 168 ± 24.3 mg/dL, compared to 161.3 ± 16.7 mg/dL using the AIDANET system. Time-in-range (TIR) 70 to 180 ...

3. datascience.virginia.edu datascience.virginia.edu/news/new-uva-clinical-trial-explores-ai-powered-insulin-delivery-better-diabetes-care

New UVA Clinical Trial Explores AI-Powered Insulin Delivery ... A new clinical trial at UVA is aiming to simplify diabetes management by testing an innovative AI-powered device designed to improve automated insulin delivery.

4. ctv.veeva.com ctv.veeva.com/study/safety-and-feasibility-testing-of-a-smaller-network-version-of-aidanet

Safety and Feasibility Testing of a Smaller Network Version of ... ... (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)

5. withpower.com withpower.com/trial/phase-diabetes-mellitus-type-1-7-2025-8757d

AIDANET Algorithm for Type 1 Diabetes This N/A medical study run by Sue Brown is evaluating whether AIDANET will have tolerable side effects & efficacy for patients with Type 1 Diabetes.

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT06728059

Safety and Feasibility of a Machine-Learning Bolus Priming ... This system consists of a Reinforcement Learning trained Bolus Priming System (BPS_RL) added to the AIDANET algorithm and running on Diabetes Assistant (DiAs) ...

7. diabetesjournals.org diabetesjournals.org/diabetes/article/74/Supplement_1/962-P/159109/962-P-Evaluating-Type-1-Diabetes-T1D-Care-across

962-P: Evaluating Type 1 Diabetes (T1D) Care across All ... The AIDANET system uses an adaptive algorithm that removes the need for meal announcement. This may help address age-specific obstacles in T1D.

8. med.virginia.edu med.virginia.edu/diabetes-technology/2025/02/05/new-uva-clinical-trial-explores-ai-powered-insulin-delivery-for-better-diabetes-care/

New UVA Clinical Trial Explores AI-Powered Insulin ... A new clinical trial at UVA is aiming to simplify diabetes management by testing an innovative AI-powered device designed to improve automated insulin delivery.

9. clinicaltrials.ucsf.edu clinicaltrials.ucsf.edu/trial/NCT07020936

AIDANET Pediatrics - UCSF Diabetes Trial This study aims to demonstrate the safety and feasibility of the Automated insulin delivery as Adaptive NETwork (AIDANET) system among children age 6-13 ...