Closed Loop Glucose Control in Patients With Type 1 and Type 2 Diabetes

Launched by IDEAL MEDICAL TECHNOLOGIES · Nov 30, 2022

Keywords

ClinConnect Summary

This clinical trial is testing a new artificial intelligence (AI) system designed to help control blood sugar levels in people with type 1 or type 2 diabetes, especially those in intensive care. The system automatically adjusts insulin to keep blood sugar in a healthy range between 100 and 140 mg/dL. During the 24-hour study, participants will eat three standard meals while the AI system manages their glucose levels to see how safe and effective it is.

To join the study, participants need to be between 18 and 70 years old, have had diabetes for at least a year, and use insulin shots to manage their blood sugar with a stable dose over the past three months. Their average blood sugar level (measured by HbA1c) should be between 7.0% and 10.0%. Participants will stay in the study for a day, during which their blood sugar will be closely monitored and controlled by the AI system. This study aims to help improve diabetes care using advanced technology, but certain health conditions or recent illnesses like COVID-19 may prevent someone from joining.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Are 18-70 years of age, inclusive.
• • 2. Can understand and sign an informed consent, communicate with the investigator, and understand and comply with the protocol requirements.
• • 3. Have had a diagnosis of type 1 or type 2 diabetes for a period of at least 1 year.
• • 4. Use insulin injections at home for glucose control and are on a stable insulin regimen without more than a 20% change in their total daily insulin dose during the previous 3 months. Their total daily insulin dose during the previous 3 months will be confirmed through a review of the subject's electronic health record, insulin prescriptions, and insulin pump settings (if applicable).
• • 5. Have a hemoglobin A1c (HbA1c) in the range of 7.0 - 10.0%.
• 6. Have a hemoglobin in the normal range for sex:
• • 1. Females: 12-15.5 grams/dL.
• • 2. Males: 13.5-17.5 grams/dl.
• • 7. Have adequate venous access sites in upper extremities.
• • 8. Body weight between 40 - 150 kg.
• Exclusion Criteria:
• • 1. Have participated in an interventional medical, surgical, or pharmaceutical study within 30 days of screening.
• • 2. Have a known hypersensitivity to any of the components of study treatment.
• • 3. Have skin disease/injury at Dexcom G6 CGM insertion site(s) that would prevent insertion of the CGM.
• • 4. Currently abuses drugs or alcohol or has a history of abuse that in the investigator's opinion would cause the individual to be noncompliant.
• • 5. Have a medical condition that in the opinion of the investigator could affect study participation and/or personal well-being.
• 6. Have a clinically significant history or presence of any of the following conditions:
• • 1. Hepatic failure or has alanine aminotransferase (ALT) greater than 3 times the upper limit of normal.
• • 2. Has an estimated glomerular filtration rate (GFR) \<60 ml/min/1.73 m2 or End Stage Kidney Disease on renal replacement therapy.
• • 3. Type 2 diabetic subjects who have a C-peptide level less than 0.2 nmol/L (these subjects will be referred to their primary care doctor or endocrinologist for further work up).
• • 4. Have congestive heart failure of class 1 or greater on the New York Heart Association (NYHA) classification system.
• • 5. Have a history of seizures.
• • 6. Have a history of cerebrovascular accident.
• • 7. Have a history of ischemic heart disease.
• 7. For female subjects of potential childbearing age (age 18 to 55) they will be excluded if:
• • 1. Pregnant.
• • 2. Refuse to agree to a pregnancy test at the time of enrollment.
• • 3. Have a positive urine pregnancy test at the time of enrollment.
• • 8. Have a positive COVID-19 test within 14 days of visit 3.
• • 9. Have any COVID-19 related symptoms in the 14-day period prior to visit 3.
• • 10. Have a known unprotected COVID-19 exposure in the 14-day period prior to visit 3.