Demonstration of an Artificial Intelligence Based Closed Loop Glucose Control System as a Therapeutic Modality in Type 2 Diabetic Patients
Sponsor: Ideal Medical Technologies
Trial Details
| Condition | Diabetes Mellitus, Type 2 |
| Intervention | FUSION closed loop glucose control system |
| Phase | N/A |
| Status | Completed |
| Participants | 3 |
| Est. Completion | 19 July 2022 |
| Last Updated | 27 Mar 2026 |
Primary Outcome
Percent of All Glucose Values Within Glucose Range < 70 mg/dL; Percent of All Glucose Values Within Glucose Range 70-180 mg/dL
Eligibility Criteria
Inclusion 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 2 diabetes for a period of at least 3 months. 4. Use insulin injections at home for glucose control. 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 GFR \<30 ml/min/1.73 m2 or End Stage Kidney Disease on renal replacement therapy. 3. Have congestive heart failure greater than class 1 on the NYHA classification system. 4. Have a history of seizures. 5. Have a history of cerebrovascular accident. 6. 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.
Trial Sites
Countries
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