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Type 1 DiabetesNCT06041971

Fully Closed Loop At Home (FCL@Home)

A study testing AIDANET system in people with Type 1 Diabetes, run by University of Colorado, Denver at 3 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

Protocol Overview/Synopsis This study will be conducted at 3 sites, with each site performing a session with up to 6 participants with a lower HbA1c (<8.0%) in one of 3 age categories (26-60, 18-25, or 14-17 years) followed by a session of up to 6 additional participants with a higher HbA1c (8.0-12.0%) with the same… Read more about this study

Who is it for?
Ages 14 to 60 years
Conditions the study is for
Type 1 Diabetes
What is being tested?
AIDANET system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
36 participants
Where
3 sitesUnited States
Study dates
1 Nov 2023to 5 May 2025
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 14 to 60 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • Age either 14-17, 18-25, or 26-60 years at time of consent.
  • Clinical diagnosis of T1D, based on investigator assessment, of at least 1 year duration.
  • HbA1c either <8.0 or 8.0-12.0% at time of consent.
  • Currently using insulin for at least 6 months.
  • Willingness to follow the protocol and sign the informed consent (and assent as applicable).
  • 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.
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  • For females, not currently known to be pregnant or breastfeeding.
  • If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a participant in the study. A negative serum or urine pregnancy test will be required for all females of childbearing potential. Participants who become pregnant will be discontinued from the study. Also, participants who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
  • Willingness to switch to use a commercially approved personal insulin (e.g., lispro or aspart, or biosimilar approved products) within the study pump as directed by the study team.
  • Currently using an insulin pump for at least the prior 6 months. Any commercially approved pump, either open loop or hybrid closed loop may be used.
  • Willingness to suspend use of any personal CGM other than Dexcom G6 once the DiAs system is in use. Participants may use their own Dexcom G6 during the study period.
  • Willingness to use the study FCL system (CGM, pump, and phone) during the relevant study period.
  • 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.
  • Access to internet at home and willingness to upload data during the study as needed.
  • Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol.
  • Participant is proficient in reading and writing English.

Who cannot join

  • Plans to start a new non-insulin glucose-lowering agent (e.g., GLP-1 receptor agonists, Symlin, DPP-4 inhibitors, sulfonylureas). Participants may be on a stable dose of such an agent for at least the past month.
  • Current use of an SGLT-2 or SGLT-1/2 inhibitor due to risk of euglycemic DKA.
  • Hemophilia or any other bleeding disorder.
  • History of severe hypoglycemic event with seizure or loss of consciousness in the last 12 months.
  • History of DKA event in the last 12 months.
  • History of chronic renal disease (CKD3b or 4) or currently on peritoneal or hemodialysis.
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  • History of adrenal insufficiency.
  • Currently being treated for a seizure disorder.
  • Hypothyroidism or hyperthyroidism that is not adequately treated.
  • Coronary artery disease or other heart condition that would prevent participation in moderate intensity exercise.
  • Use of oral or injectable steroids at the time of enrollment or within the last 4 weeks.
  • Planned surgery during the study period.
  • Known ongoing adhesive intolerance that is not well managed.
  • A condition, which in the opinion of the investigator or designee, would put the participant or study at risk.
  • Participation in another interventional trial at the time of enrollment.
  • Participant does not have a direct supervisor involved in the conduct of the trial.

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Barbara Davis Center

    Aurora, Colorado, 80045

  • University of Virginia

    Charlottesville, Virginia, 22904

  • University of California San Francisco

    San Francisco, California, 94158

Other trials in United States

About this study

Official title: Safety and Feasibility Testing of a Fully Closed Loop System in Adolescents and Adults with Higher Baseline HbA1c Values

Protocol Overview/Synopsis This study will be conducted at 3 sites, with each site performing a session with up to 6 participants with a lower HbA1c (<8.0%) in one of 3 age categories (26-60, 18-25, or 14-17 years) followed by a session of up to 6 additional participants with a higher HbA1c (8.0-12.0%) with the same age categories (26-60, 18-25, or 14-17 years). The trial will aim to complete a total of 36 participants: 12 total participants within each age category and 18 participants within each HbA1c category; 12 participants at each site. The study may enroll up to 70 participants to account for dropouts across the study. The study will be performed for 5 days and 4 nights at a local hotel/rental. Following the hotel session, participants will undergo a 7 day/6-night remote monitored at-home use session. The study will also conduct a two-week control period gathering data on glycemic control and insulin administration with the participants usual care therapy. Participants will be randomized 1:1, stratified by age cohort, to either group A (control period prior to AIDANET use) or group B (control period after AIDANET use).

Conditions
Type 1 Diabetes
Being tested
AIDANET system
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AIDANET systemDevice

    The study will involve testing a new AID system designed to enable full closed loop control and consisting of the following elements: the diabetes assistant (DiAs) prototyping platform (MAF 2019), connected to a Tandem t:AP research insulin pump and a Dexcom G6 CGM, and implementing the University of Virginia (UVA) AIDANET algorithm.

Study groups in NCT06041971
Study groupRoleWhat they receive
Group AExperimentalTwo-week control period before the use of the AIDANET system.
Receives: Device: AIDANET system
Group BExperimentalTwo-week control period after the use of the AIDANET system.
Receives: Device: AIDANET system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean Sensor Glucose Value

    The primary metric for analysis will be change in mean sensor glucose value between the second week of the control usual-care period and the one-week remote monitored at-home FCL period.

    Measured: Change between second week of the control period and the one-week at home period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Sep 2023
  2. Study start1 Nov 2023
  3. Primary completion20 Oct 2024
  4. Study completion5 May 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Crossover
Model description
Treatment Groups Randomized Crossover: Participants will be randomized 1:1 within each age cohort to either conduct the two-week control period before use of the AIDANET system (group A) or after use of the AIDANET system (group B).
Masking
None (open label)
Enrolment
36 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06041971
Sponsor's protocol ID
23-1684
Status last verified
Dec 2024
First submitted
5 Sep 2023
Last updated
18 Dec 2024
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing AIDANET system in people with Type 1 Diabetes, run by University of Colorado, Denver at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 18 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean Sensor Glucose Value (time frame: Change between second week of the control period and the one-week at home period). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06041971.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2024.

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Fully Closed Loop At Home (FCL@Home) (NCT06041971) | AzTrials