Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adults and Pediatrics Utilizing Lyumjev®

Completed · Not applicable

Conditions studied: Type 1 Diabetes

In brief

This US study will evaluate the safety and effectiveness of utilizing insulin Lyumjev® lispro-aabc in the MiniMed™ 780G System in Type 1 adult and pediatric subjects in a home setting to support product and system labeling.

Key facts

Study ID

NCT05325294

Run by

Medtronic MiniMed, Inc.

People needed

244

Starts

2022-05-05

Expected to finish

2024-01-03

Last updated by the study team

2025-01-15

Who can join

Age: 7 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 7-80 years at time of screening.
• Has a clinical diagnosis of type 1 diabetes:
• 14-80 years of age: A clinical diagnosis of type 1 diabetes for 2 years or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis.
• 7-13 years of age: A clinical diagnosis of type 1 diabetes for 1 year or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis.
• Does not require a legally authorized representative to consent on their behalf due to mental or intellectual disability.
• Subject or parent/caregiver is literate and able to read the language offered in the pump or pump materials.
• Subject and/or legally authorized representative is willing to provide informed consent for participation.
• Is willing to perform fingerstick blood glucose measurements as needed.
• Is willing to wear the system continuously throughout the study.
• Must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units and a maximum total daily dose of 250 units or less.
• Has a Glycosylated hemoglobin (HbA1c) less than 10% (as processed by Central Lab) at time of screening visit.
• Note: All HbA1c blood specimens will be sent to and tested by a National Glycohemoglobin Standardization Program (NGSP) certified Central Laboratory. HbA1c testing must follow NGSP standards.
• Has thyroid-stimulating hormone (TSH) in the normal range OR if the TSH is out of normal reference range, the Free T3 is below or within the lab's reference range and Free T4 is within the normal reference range.
• Uses pump therapy for greater than 6 months (with or without CGM experience) prior to screening
• Is willing to upload data from the study pump, must have Internet access, and a computer system, or compatible smartphone that meets the requirements for uploading the study pump.
• Is willing to take one of the following insulins and can financially support the use of insulin preparations as required during the run-in period:
• Humalog (insulin lispro injection)
• NovoLog (insulin aspart injection)
• Admelog(insulin lispro injection)
• Is willing to take Lyumjev insulin during the study period (supplied via Sponsor).

You may not qualify if…

• Has hypersensitivity to insulin lispro or one of the excipients in Lyumjev®
• Has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to screening:
• Medical assistance (i.e., Paramedics, Emergency Room [ER] or Hospitalization)
• Coma
• Seizures
• Has been hospitalized or has visited the ER in the 6 months prior to screening resulting in a primary diagnosis of uncontrolled diabetes.
• Has had DKA in the last 6 months prior to screening visit.
• Will not tolerate tape adhesive in the area of sensor placement as assessed by a qualified individual.
• Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
• Is female of child-bearing potential and result of pregnancy test is positive at screening.
• Is sexually active female of child-bearing potential and is not using a form of contraception deemed reliable by the investigator.
• Is female and plans to become pregnant during the course of the study
• Is being treated for hyperthyroidism at time of screening.
• Has diagnosis of adrenal insufficiency.
• Has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV glucocorticoid during the course of the study.
• Is using hydroxyurea at time of screening or plans to use it during the study.
• Is actively participating in an investigational study (drug or device) wherein he/she has received treatment from an investigational study drug or investigational study device in the last 2 weeks.
• Is currently abusing illicit drugs.
• Is currently abusing marijuana.
• Is currently abusing prescription drugs.
• Is currently abusing alcohol.
• Using pramlintide (Symlin), DPP-4 inhibitor, liraglutide (Victoza or other GLP-1 agonists), metformin, canagliflozin (Invokana or other SGLT2 inhibitors) at time of screening.
• Has a history of visual impairment which would not allow subject to participate in the study and perform all study procedures safely, as determined by the investigator.
• Has elective surgery planned that requires general anesthesia during the course of the study.
• Has sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening.

Where it is running

• Stanford University — Palo Alto, California, United States
• Rady Children's Hospital San Diego — San Diego, California, United States
• Barbara Davis Center for Childhood Diabetes — Aurora, Colorado, United States
• Barbara Davis Center — Aurora, Colorado, United States
• Yale University — New Haven, Connecticut, United States
• East Coast Institute for Research (Memorial Hospital) — Jacksonville, Florida, United States
• University of South Florida Diabetes Center — Tampa, Florida, United States
• Atlanta Diabetes — Atlanta, Georgia, United States
• East Coast Institute for Research - Macon — Macon, Georgia, United States
• Endocrine Research Solutions — Roswell, Georgia, United States
• Rocky Mountain — Idaho Falls, Idaho, United States
• Barry J Reiner MD LLC — Baltimore, Maryland, United States
• Mayo Clinic — Rochester, Minnesota, United States
• International Diabetes Center — Saint Louis Park, Minnesota, United States
• The Docs LLC — Las Vegas, Nevada, United States
• Physicians East — Greenville, North Carolina, United States
• Texas Diabetes — Austin, Texas, United States
• Diabetes and Glandular Disease Clinic, P.A — San Antonio, Texas, United States
• Rainier Research — Renton, Washington, United States

Full record on ClinicalTrials.gov

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