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Effectiveness of Artificial-Intelligence (AI) Bolus Priming Added to an Existing Fully Automated Control Algorithm (AIDANET)

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

  • Time periods mentioned: 2 weeks

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
  • "Following enrollment and screening, participants will be randomized 1:1 to two 8-week sequences: Group A participants will continue to use their home Hybrid closed loop (HCL) system for 2 weeks, then switch to AIDANET for two weeks, and the switch to AIDANET AI for another 4 weeks."
  • "Group B participants will begin with 4 weeks of AIDANET AI, then switch to AIDANET for 2 weeks and then revert to their home HCL systems for the last 2 weeks of the study (Figure 1)."
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 whether adding artificial intelligence (AI) that learns meal patterns helps an automated insulin delivery system work better. The system uses an iPhone linked wirelessly to an insulin pump and a sensor that tracks blood sugar. It is for adults with type 1 diabetes who already use automated insulin delivery.

Bolus Priming (BP) based on Artificial Intelligence (AI) learning of meal patterns, added to our established Automated insulin delivery as Adaptive Network (AIDANET) algorithm and running on iPhone Diabetes Assistant (iDiAs) phone wirelessly connected to Tandem Mobi insulin pump and Dexcom Continuous Glucose Monitor (CGM).

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

Eligibility

Who can join

  • Be age 18 or older and have had type 1 diabetes for at least 1 year.
  • Currently use an automated insulin delivery system.
  • Agree to use the study pump, blood sugar sensor, and phone, and switch to an approved insulin as directed.
  • Have a support person who lives with you or is about 30 minutes away. They must know how to handle dangerously low blood sugar, find you, and call for help.
  • Not be pregnant or breastfeeding. If you can become pregnant, you must have a negative pregnancy test and use birth control. You must leave the study if you become pregnant or plan pregnancy during it.
  • Agree to all study steps and not start any new blood sugar medicine other than insulin.
  • Have home internet and agree to upload study data as needed.
  • Be able to read and write English. The study doctor must believe you can use the devices and follow the study rules.

Who can't join

  • Plan to start a new blood sugar medicine other than insulin, or currently take an SGLT-2 or SGLT-1/2 inhibitor. Other non-insulin blood sugar medicines are allowed if the dose has stayed the same for at least 1 month.
  • Have a bleeding disorder, or had dangerously low blood sugar causing a seizure or passing out in the past 12 months.
  • Had diabetic ketoacidosis, a dangerous buildup of acids in the blood, in the past 12 months.
  • Have unstable stage 4 kidney disease, or receive dialysis, a treatment that removes waste from the blood.
  • Are being treated for low adrenal hormone levels or seizures, or have an overactive or underactive thyroid that is not well treated.
  • Take steroid pills or shots now or took them in the past 2 weeks, or plan surgery that would require a long break from the study devices.
  • Have ongoing problems with device adhesives that are not well controlled, or another condition the study doctor thinks could put you or the study at risk.
  • Are in another study testing a treatment when you enroll, or have a direct supervisor who helps run this study.

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

Official eligibility criteria

Inclusion Criteria: 1. Age ≥18.0 years old at time of consent 2. Clinical diagnosis, based on investigator assessment, of Type 1 Diabetes (T1D) for at least one year. 3. Currently using an automated insulin delivery (AID) system. 4. 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. 5. Has one or more supportive companions knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff that either live with participant or located within approximately 30 minutes of participant and able to locate participant in the event of an emergency. 6. Participant not currently known to be pregnant or breastfeeding. 7. 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 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. 8. Willingness to use the study AIDANET system (CGM, insulin pump, and phone) during the study period. 9. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial. 10. Willingness to participate in all study procedures. 11. Access to internet at home and willingness to upload data during the study as needed. 12. Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol. 13. Participant is proficient in reading and writing English. Exclusion Criteria: 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, sulfonylureas). Participants may be on a stable dose of such an agent for at least the past month. 2. Current use of an sodium-glucose transport protein 2 (SGLT-2) or SGLT-1/2 inhibitor due to risk of euglycemic diabetic ketoacidosis (DKA). 3. Hemophilia or any other bleeding disorder. 4. History of severe hypoglycemic events with seizure or loss of consciousness in the last 12 months. 5. History of DKA event in the last 12 months. 6. Unstable Stage 4 chronic renal disease or currently on peritoneal or hemodialysis. 7. Currently being treated for adrenal insufficiency. 8. Currently being treated for a seizure disorder. 9. Hypothyroidism or hyperthyroidism that is not adequately treated. 10. Use of oral or injectable steroids at the time of enrollment or within the last 2 weeks. 11. Planned surgery during the study period that results in prolonged disconnection from study devices. 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 involved in the conduct of the trial.

Study sites (1)

VA