Type 1 Diabetes (T1D)INSIGHTNCT07507708
Insulin Delivery With Self-Adjusting Closed-Loop and Behavioral Glycemic Control Enhanced by Prediction
A study testing Automated Insulin Delivery (AID), AIDANET + Fully Closed Loop (FCL) and AIDANET + Anticipatory Closed Loop (ACL) in people with Type 1 Diabetes (T1D), run by Sue Brown at 1 site in United States.
Trial summary
This study is a randomized cross-over trial comparing AIDANET with Anticipation to AIDANET in FCL without Anticipation. Participants will complete 4 weeks of AID data collection which will be used to establish baseline and initialize the control algorithm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes (T1D)
- What is being tested?
- Automated Insulin Delivery (AID), AIDANET + Fully Closed Loop (FCL) and AIDANET + Anticipatory Closed Loop (ACL)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 14 May 2026to 31 Dec 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Participant Inclusion Criteria
- Age ≥18.0 years old at time of consent
- Clinical diagnosis, based on investigator assessment, of T1D for > 1 year.
- Having used an FDA approved AID system within the last 6 months (can be intermittent use).
- Currently using insulin for >6 months.
- Willingness to switch to use an FDA-approved personal insulin for the study pump (e.g., lispro or aspart, or biosimilar FDA-approved products) as directed by the study team.
- Has one or more supportive companions knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff who either lives with participant or located within approximately 30 minutes of participant and able to locate participant in the event of an emergency.
- Participant not currently known to be pregnant or breastfeeding.
- If participant can become pregnant, they 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 participants 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 wear a Dexcom CGM during each of the study phases.
- Willingness to use the study AIDANET system (CGM, pump, and phone) during the relevant study periods.
- Willingness not to start any new non-insulin glucose-lowering agent during the trial.
- Willingness to participate in all study procedures including in person training.
- 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 can adhere to the protocol.
- Participant is proficient in reading and verbal communication in English.
Participant Exclusion Criteria The participant must not have any exclusion criteria to be eligible to participate in the study.
- Plans to start a new non-insulin glucose-lowering agent (e.g., GLP-1 receptor agonists, Symlin, DPP-4 inhibitors,). Participants may be on a stable dose of such an agent for at least the past month.
- Current use of sulfonylurea medications.
- Uncontrolled microvascular complications such as active proliferative retinopathy not being treated or not responsive to current treatment.
- 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 events with seizure or loss of consciousness in the last 12 months.
- History of DKA event in the last 12 months.
- Currently on peritoneal or hemodialysis.
- Currently being treated for adrenal insufficiency.
- Currently being treated for a seizure disorder.
- Hypothyroidism or hyperthyroidism that is not adequately treated.
- Use of oral or injectable steroids at the time of enrollment.
- 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 with a direct supervisor at work/school who is involved in the conduct of the trial.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22903
Sue Brown, MD, 4349820602, sab2f@uvahealth.org
Marcela Moscoso-Vasquez, PhD
About this study
Official title: Insulin Delivery With Self-Adjusting Closed-Loop and Behavioral Glycemic Control Enhanced by Prediction (INSIGHT)
This study is a randomized cross-over trial comparing AIDANET with Anticipation to AIDANET in FCL without Anticipation. Participants will complete 4 weeks of AID data collection which will be used to establish baseline and initialize the control algorithm. Participants will then be randomized to one of two groups: Group A: AIDANET in FCL with Anticipation (AIDANET+ACL), and Group B: AIDANET in FCL without Anticipation (AIDANET+FCL). The study duration of each group is 4 weeks each. The order of these two phases will be dependent upon randomization.
Read the detailed description
The UVA AIDANET algorithm is intended for use by patients with T1D to control the subcutaneous infusion of insulin and aid in their T1D self-management. AIDANET automatically adjusts insulin delivery every 5 minutes in response to CGM values. AIDANET can be used with meal announcement (hybrid closed loop, HCL), without meal announcement (full closed loop, FCL), and with meal anticipation (anticipatory closed loop, ACL).
The purpose of this study is to demonstrate superior glycemic control when using anticipation within our latest Automated Insulin Delivery as Adaptive NETwork (AIDANET) in FCL with Anticipation (AIDANET+ACL) vs. AIDANET in FCL without Anticipation.
- Conditions
- Type 1 Diabetes (T1D)
- Being tested
- Automated Insulin Delivery (AID), AIDANET + Fully Closed Loop (FCL), AIDANET + Anticipatory Closed Loop (ACL)
- Keywords
- Automated insulin delivery as Adaptive Network (AIDANET), Fully automated Closed Loop (FCL), Hybrid Closed Loop (HCL), Continuous subcutaneous insulin infusion (CSII), Insulin Pump, Tandem Mobi system, Anticipatory Closed Loop (ACL)
- 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.
Automated Insulin Delivery (AID)Device
Usual Care
AIDANET + Fully Closed Loop (FCL)Device
All participants will use AIDANET in FCL mode with instructions to avoid announcing meal boluses whenever possible during the four weeks.
AIDANET + Anticipatory Closed Loop (ACL)Device
All insulin will be delivered automatically. The algorithm will review past behaviors to determine the amount of insulin that will be needed for a meal.
| Study group | Role | What they receive |
|---|---|---|
| Group A: AID first followed by AIDANET+ACL then AIDANET+FCL | Active comparator | Participants will first complete 4 weeks of AID data collection which will be used to establish baseline and initialize the control algorithm. Participants will then complete 4 weeks of AIDANET + Anticipatory Closed Loop (ACL) and 4 weeks of AIDANET + Fully Closed-Loop (FCL) Receives: Device: Automated Insulin Delivery (AID); Device: AIDANET + Fully Closed Loop (FCL); Device: AIDANET + Anticipatory Closed Loop (ACL) |
| Group B: AID first followed by AIDANET+FCL then AIDANET+ACL | Active comparator | Participants will first complete 4 weeks of AID data collection which will be used to establish baseline and initialize the control algorithm. Participants will then complete 4 weeks of AIDANET + Fully Closed Loop (FCL) and 4 weeks of AIDANET+ Anticipatory Closed Loop (ACL). Receives: Device: Automated Insulin Delivery (AID); Device: AIDANET + Fully Closed Loop (FCL); Device: AIDANET + Anticipatory Closed Loop (ACL) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in range 70-140 mg/dL as computed by the study CGM
Computed as the number of estimated glucose values ≥70mg/dL and <140mg/dL divided by the number of valid values (defined as a number between 39 and 401)
Measured: 8 weeks
Time in range 70-140 mg/dL as computed by the study CGM
Outcome is computed if:
- >4032 values are recorded (availability condition, 2 weeks equivalent)
- AND there is >70% values between the first recorded EGV of the analysis window and the last (density condition)
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2026
- Study start14 May 2026
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes (T1D)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sue Brown
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Tandem Diabetes Care, Inc., DexCom, Inc.
- Responsible party
- Sponsor-investigator, Sue Brown, University of Virginia
- Investigators
- Sue A Brown, MD, Principal investigator, University of Virginia Center for Diabetes Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07507708
- Sponsor's protocol ID
- 302996
- Other IDs
- 5R01DK129553
- Acronym
- INSIGHT
- Status last verified
- Jun 2026
- First submitted
- 27 Mar 2026
- Last updated
- 22 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insulin Delivery With Self-Adjusting Closed-Loop and Behavioral Glycemic Control Enhanced by Prediction (INSIGHT)
- ClinicalTrials.gov ID
- NCT07507708
- Acronym / sponsor ID
- INSIGHT / 302996
- Conditions
- Type 1 Diabetes (T1D)
- Keywords
- Automated insulin delivery as Adaptive Network (AIDANET), Fully automated Closed Loop (FCL), Hybrid Closed Loop (HCL), Continuous subcutaneous insulin infusion (CSII), Insulin Pump, Tandem Mobi system, Anticipatory Closed Loop (ACL)
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Sue BrownUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Tandem Diabetes Care, Inc., DexCom, Inc.
- Study start
- 14 May 2026 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 2 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a randomized cross-over trial comparing AIDANET with Anticipation to AIDANET in FCL without Anticipation. Participants will complete 4 weeks of AID data collection which will be used to establish baseline and initialize the control algorithm. Participants will then be randomized to one of two groups: Group A: AIDANET in FCL with Anticipation (AIDANET+ACL), and Group B: AIDANET in FCL without Anticipation (AIDANET+FCL). The study duration of each group is 4 weeks each. The order of these two phases will be dependent upon randomization.
Detailed description
The UVA AIDANET algorithm is intended for use by patients with T1D to control the subcutaneous infusion of insulin and aid in their T1D self-management. AIDANET automatically adjusts insulin delivery every 5 minutes in response to CGM values. AIDANET can be used with meal announcement (hybrid closed loop, HCL), without meal announcement (full closed loop, FCL), and with meal anticipation (anticipatory closed loop, ACL).
The purpose of this study is to demonstrate superior glycemic control when using anticipation within our latest Automated Insulin Delivery as Adaptive NETwork (AIDANET) in FCL with Anticipation (AIDANET+ACL) vs. AIDANET in FCL without Anticipation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A: AID first followed by AIDANET+ACL then AIDANET+FCL | Active comparator | Device: Automated Insulin Delivery (AID), Device: AIDANET + Fully Closed Loop (FCL), Device: AIDANET + Anticipatory Closed Loop (ACL)Participants will first complete 4 weeks of AID data collection which will be used to establish baseline and initialize the control algorithm. Participants will then complete 4 weeks of AIDANET + Anticipatory Closed Loop (ACL) and 4 weeks of AIDANET + Fully Closed-Loop (FCL) |
| Group B: AID first followed by AIDANET+FCL then AIDANET+ACL | Active comparator | Device: Automated Insulin Delivery (AID), Device: AIDANET + Fully Closed Loop (FCL), Device: AIDANET + Anticipatory Closed Loop (ACL)Participants will first complete 4 weeks of AID data collection which will be used to establish baseline and initialize the control algorithm. Participants will then complete 4 weeks of AIDANET + Fully Closed Loop (FCL) and 4 weeks of AIDANET+ Anticipatory Closed Loop (ACL). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Automated Insulin Delivery (AID)Usual Care | Device | Group A: AID first followed by AIDANET+ACL then AIDANET+FCL, Group B: AID first followed by AIDANET+FCL then AIDANET+ACL |
| AIDANET + Fully Closed Loop (FCL)All participants will use AIDANET in FCL mode with instructions to avoid announcing meal boluses whenever possible during the four weeks. | Device | Group A: AID first followed by AIDANET+ACL then AIDANET+FCL, Group B: AID first followed by AIDANET+FCL then AIDANET+ACL |
| AIDANET + Anticipatory Closed Loop (ACL)All insulin will be delivered automatically. The algorithm will review past behaviors to determine the amount of insulin that will be needed for a meal. | Device | Group A: AID first followed by AIDANET+ACL then AIDANET+FCL, Group B: AID first followed by AIDANET+FCL then AIDANET+ACL |
Primary outcome
Time in range 70-140 mg/dL as computed by the study CGM
Time frame: 8 weeks
Computed as the number of estimated glucose values ≥70mg/dL and <140mg/dL divided by the number of valid values (defined as a number between 39 and 401)
Time in range 70-140 mg/dL as computed by the study CGM
Time frame: 8 weeks
Outcome is computed if: * >4032 values are recorded (availability condition, 2 weeks equivalent) * AND there is >70% values between the first recorded EGV of the analysis window and the last (density condition)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sue A Brown, MD principal investigator
University of Virginia Center for Diabetes Technology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Automated Insulin Delivery (AID), AIDANET + Fully Closed Loop (FCL) and AIDANET + Anticipatory Closed Loop (ACL) in people with Type 1 Diabetes (T1D), run by Sue Brown at 1 site 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?
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: looking for participants now, as of the sponsor's last update on 22 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Contact Andrea Riana, MD ((434) 249-6251, rys6hm@uvahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time in range 70-140 mg/dL as computed by the study CGM (time frame: 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Jun 2026; AzTrials last refreshed its copy on 30 Oct 2026.