RecruitingNot applicable

Insulin Delivery With Self-Adjusting Closed-Loop and Behavioral Glycemic Control Enhanced by Prediction

Insulin Delivery With Self-Adjusting Closed-Loop and Behavioral Glycemic Control Enhanced by Prediction (INSIGHT)

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests AIDANET, a system that adjusts insulin delivery, with and without a prediction feature called Anticipation. It is for adults with type 1 diabetes who have used an automated insulin delivery system in the past 6 months. After 4 weeks of data collection, each person will use both versions for 4 weeks each, in an order chosen by chance.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18, have type 1 diabetes for more than 1 year, and have used insulin for more than 6 months.
  • Have used an FDA-approved automated insulin delivery system in the past 6 months, even if not all the time.
  • Agree to use the study system, including a Dexcom continuous glucose monitor (a sensor that tracks blood sugar), pump, and phone. Switch to an approved pump insulin if directed.
  • Have a support person who lives with you or is about 30 minutes away, can find you, and knows how to get help for dangerously low blood sugar.
  • Not be pregnant or breastfeeding. If you can become pregnant, have a negative pregnancy test and agree to use birth control. Pregnancy or plans to become pregnant during the study will end participation.
  • Agree not to start any new blood sugar medicine other than insulin during the study.
  • Attend all study activities, including in-person training. Have home internet and agree to upload study data.
  • Be able to read and speak English. The study doctor must believe you can use the devices and follow study instructions.

Who can't join

  • Plan to start a new blood sugar medicine other than insulin, or currently take sulfonylureas or SGLT-2 or SGLT-1/2 inhibitors. Other non-insulin blood sugar medicines must have been at a stable dose for at least 1 month.
  • Have uncontrolled damage to small blood vessels, such as serious eye disease that is untreated or not helped by treatment.
  • Have a bleeding disorder, or a poorly managed reaction to the sticky patches used for devices.
  • In the past 12 months, have had low blood sugar causing a seizure or passing out, or diabetic ketoacidosis (a dangerous buildup of acids in the blood).
  • Receive dialysis (treatment that filters the blood), or treatment for low adrenal hormones or a seizure disorder.
  • Have an underactive or overactive thyroid that is not well treated, or take steroid pills or injections when joining.
  • Have another condition that the study team believes could put you or the study at risk.
  • Be in another study testing a treatment when joining, or have a direct boss or school supervisor who helps run this study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Participant Inclusion Criteria 1. Age ≥18.0 years old at time of consent 2. Clinical diagnosis, based on investigator assessment, of T1D for \> 1 year. 3. Having used an FDA approved AID system within the last 6 months (can be intermittent use). 4. Currently using insulin for \>6 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 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. 9. Willingness to wear a Dexcom CGM during each of the 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 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 can adhere to the protocol. 15. 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. 1. 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. 2. Current use of sulfonylurea medications. 3. Uncontrolled microvascular complications such as active proliferative retinopathy not being treated or not responsive to current treatment. 4. Current use of an SGLT-2 or SGLT-1/2 inhibitor due to risk of euglycemic DKA. 5. Hemophilia or any other bleeding disorder. 6. History of severe hypoglycemic events with seizure or loss of consciousness in the last 12 months. 7. History of DKA event in the last 12 months. 8. Currently on peritoneal or hemodialysis. 9. Currently being treated for adrenal insufficiency. 10. Currently being treated for a seizure disorder. 11. Hypothyroidism or hyperthyroidism that is not adequately treated. 12. Use of oral or injectable steroids at the time of enrollment. 13. Known ongoing adhesive intolerance that is not well managed. 14. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk. 15. Participation in another interventional trial at the time of enrollment. 16. Participant with a direct supervisor at work/school who is involved in the conduct of the trial.

Study sites (1)

VA

  • University of Virginia Center for Diabetes Technology · Charlottesville, VA 22903Sue Brown, MD · Study contact · 4349820602 · sab2f@uvahealth.orgMarcela Moscoso-Vasquez, PhD · Sub-investigatorSamina Afreen, MD · Sub-investigatorMark DeBoer, MD · Sub-investigatorMore trials in Charlottesville