RECRUITING

AIDANET At Home Study

Conditions

Type 1 Diabetes Automated Insulin Delivery (AID)Fully Closed Loop (FCL)Hybrid Closed Loop (HCL)Specifically modified Mobi System Automated Insulin Delivery as Adaptive NETwork (AIDANET)

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

A randomized cross-over trial assessing glycemic control on Automated insulin delivery as Adaptive Network (AIDANET) algorithm when used in three modes: AIDANET-Fully Closed Loop (FCL), AIDANET-Hybrid Closed Loop (HCL) and AIDANET allowing a mix between FCL and HCL. There will be an Automated Insulin Delivery (AID) phase with participants using their home devices and/or study continuous glucose monitor (CGM) and study-provided commercial Mobi system without AIDANET.

Official Title

A Randomized Parallel Clinical Trial of AIDANET, an Automated Insulin Delivery Algorithm, in Fully Closed-Loop Vs Hybrid Closed-Loop Mode In Adults With Type 1 Diabetes

Quick Facts

Study Start:2025-08-30

Study Completion:2026-07-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT07039617

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. Age ≥18.0 years old at time of consent 2. Clinical diagnosis, based on investigator assessment, of Type 1 Diabetes for at least one year. 3. Having used an Food and Drug Administration (FDA) approved AID system within the last six months (can be intermittent use). 4. Currently using insulin for at least six months. 5. 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. 6. 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. 7. Participant not currently known to be pregnant or breastfeeding. 8. If participant capable of becoming pregnant, must agree to use a form of contraception to prevent pregnancy while a participant in the study (e.g. hormonal contraception, abstinence from heterosexual intercourse). 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. 9. Willingness to wear a Dexcom CGM during each of the four study phases. 10. Willingness to use the study AIDANET system (CGM, pump, and phone) during the relevant study periods. 11. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial. 12. Willingness to participate in all study procedures including in person training. 13. Access to internet at home and willingness to upload data during the study as needed. 14. Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol. 15. Participant is proficient in reading and verbal communication in English.	1. Plans to start a new non-insulin glucose-lowering agent (e.g. glucagon-like peptide-1 (GLP-1) receptor agonists, Symlin, (DPP-4 inhibitors, also known as dipeptidyl peptidase 4). Participants may be on a stable dose of such an agent for at least the past month. 2. Current use of sulfonylurea medications. 3. Current use of an Sodium-Glucose Cotransporter 2 (also known as a SGLT-2 or SGLT-1/2 inhibitor) due to risk of euglycemic diabetic ketoacidosis (DKA). 4. Hemophilia or any other bleeding disorder. 5. History of severe hypoglycemic events with seizure or loss of consciousness in the last 12 months. 6. History of DKA event in the last 12 months. 7. Currently on peritoneal or hemodialysis. 8. Currently being treated for adrenal insufficiency. 9. Currently being treated for a seizure disorder. 10. Hypothyroidism or hyperthyroidism is not adequately treated. 11. Use of oral or injectable steroids at the time of enrollment. 12. Known ongoing adhesive intolerance that is not well managed. 13. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk. 14. Participation in another interventional trial at the time of enrollment. 15. Participant with a direct supervisor at work/school who is involved in the conduct of the trial.

Inclusion Criteria

Exclusion Criteria

1. Age ≥18.0 years old at time of consent
2. Clinical diagnosis, based on investigator assessment, of Type 1 Diabetes for at least one year.
3. Having used an Food and Drug Administration (FDA) approved AID system within the last six months (can be intermittent use).
4. Currently using insulin for at least six months.
5. 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.
6. 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.
7. Participant not currently known to be pregnant or breastfeeding.
8. If participant capable of becoming pregnant, must agree to use a form of contraception to prevent pregnancy while a participant in the study (e.g. hormonal contraception, abstinence from heterosexual intercourse). 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.
9. Willingness to wear a Dexcom CGM during each of the four study phases.
10. Willingness to use the study AIDANET system (CGM, pump, and phone) during the relevant study periods.
11. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial.
12. Willingness to participate in all study procedures including in person training.
13. Access to internet at home and willingness to upload data during the study as needed.
14. Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol.
15. Participant is proficient in reading and verbal communication in English.

1. Plans to start a new non-insulin glucose-lowering agent (e.g. glucagon-like peptide-1 (GLP-1) receptor agonists, Symlin, (DPP-4 inhibitors, also known as dipeptidyl peptidase 4). Participants may be on a stable dose of such an agent for at least the past month.
2. Current use of sulfonylurea medications.
3. Current use of an Sodium-Glucose Cotransporter 2 (also known as a SGLT-2 or SGLT-1/2 inhibitor) due to risk of euglycemic diabetic ketoacidosis (DKA).
4. Hemophilia or any other bleeding disorder.
5. History of severe hypoglycemic events with seizure or loss of consciousness in the last 12 months.
6. History of DKA event in the last 12 months.
7. Currently on peritoneal or hemodialysis.
8. Currently being treated for adrenal insufficiency.
9. Currently being treated for a seizure disorder.
10. Hypothyroidism or hyperthyroidism is not adequately treated.
11. Use of oral or injectable steroids at the time of enrollment.
12. Known ongoing adhesive intolerance that is not well managed.
13. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk.
14. Participation in another interventional trial at the time of enrollment.
15. Participant with a direct supervisor at work/school who is involved in the conduct of the trial.

Contacts and Locations

Study Contact

Lianna Smith

CONTACT

434-284-0893

LHS7PX@uvahealth.org

Carlene Alix

CONTACT

(434) 243-2855

uax8yx@virginia.edu

Principal Investigator

Sue Brown, MD

PRINCIPAL_INVESTIGATOR

University of Virginia Center for Diabetes Technology

Study Locations (Sites)

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, 22903

United States

Collaborators and Investigators

Sponsor: Sue Brown

Sue Brown, MD, PRINCIPAL_INVESTIGATOR, University of Virginia Center for Diabetes Technology

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-08-30

Study Completion Date2026-07-31

Study Record Updates

Study Start Date2025-08-30

Study Completion Date2026-07-31

Terms related to this study

Keywords Provided by Researchers

Automated Insulin Delivery (AID)
Fully Closed Loop (FCL)
Hybrid Closed Loop (HCL)
Specifically modified Mobi System
Automated Insulin Delivery as Adaptive NETwork (AIDANET)

Additional Relevant MeSH Terms

Type 1 Diabetes