In-Home Study With MiniMed™ 780G Pump Automated Control in Type 2-Evaluation of the AHCL System in Adults With Insulin-requiring Type 2 Diabetes

Last updated: February 19, 2025
Sponsor: Medtronic Diabetes
Overall Status: Completed

Phase

N/A

Condition

Diabetes And Hypertension

Diabetes Prevention

Diabetes Mellitus, Type 2

Treatment

MiniMed™ 780G Insulin Pump system

Clinical Study ID

NCT05238142
CIP341
  • Ages 18-80
  • All Genders

Study Summary

The objective of the study is to assess the safety and effectiveness of MiniMed™ 780G system in adult subjects with insulin-requiring type 2 diabetes in a home setting. The combined run-in period and study period will be approximately 135 days long.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Is age 18 - 80 years at time of screening.

  2. Has a clinical diagnosis of type 2 diabetes for 2 years or more as determined viamedical record or source documentation by an individual qualified to make a medicaldiagnosis.

  3. Is on MDI regimen (basal/bolus regimen with long-acting insulin and rapid-actinganalogs), defined as greater than or equal to 2 injections per day for at least 3months prior signing the informed consent, or CSII pump therapy with or without CGM.The investigator will use their discretion to verify that insulin requirements havebeen stable for the last 3 months prior to screening.

  4. Is able to comply with technology, according to Investigator's judgment

  5. Does not require a legally authorized representative to consent on their behalf dueto mental or intellectual disability.

  6. Is willing to perform fingerstick blood glucose measurements as needed.

  7. Is willing to wear the system continuously throughout the study.

  8. Has a Glycosylated hemoglobin (HbA1c) of 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 NationalGlycohemoglobin Standardization Program (NGSP) certified Central Laboratory. HbA1ctesting must follow NGSP standards.

  9. Has thyroid-stimulating hormone (TSH) in the normal range OR if the TSH is out ofnormal reference range the Free T3 is below or within the lab's reference range andFree T4 is within the normal reference range.

  10. Is willing to upload data from the study pump, must have Internet access, and acomputer system, or compatible smartphone that meets the requirements for uploadingthe study pump.

  11. Is willing to take one of the following insulins and can financially support the useof insulin preparations as required by the study:

  12. Humalog (insulin lispro injection)

  13. NovoLog/NovoRapid (insulin aspart injection)

  14. Admelog (insulin lispro injection)

Exclusion

Exclusion Criteria:

  1. Has a history of 2 or more episodes of severe hypoglycemia, which resulted in anythe following during the 6 months prior to screening:

  2. Medical assistance (i.e., Paramedics, Emergency Room [ER] or Hospitalization)

  3. Coma

  4. Seizures

  5. Has been hospitalized or has visited the ER in the 6 months prior to screeningresulting in a primary diagnosis of uncontrolled diabetes.

  6. Has had diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar syndrome (HHS) inthe last 6 months prior to screening visit.

  7. Will not tolerate tape adhesive in the area of sensor placement as assessed by aqualified individual.

  8. Has any unresolved adverse skin condition in the area of sensor placement (e.g.,psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection) at time ofscreening.

  9. Has (Total Daily Dose) of less than 8 units or greater than 250 units at time ofscreening.

  10. Has positive GAD (Glutamic Acid Decarboxylase) Antibody test

  11. Is female of child-bearing potential and result of pregnancy test is positive atscreening

  12. Is sexually active female of child-bearing potential and is not using a form ofcontraception deemed reliable by the investigator.

  13. Is female and plans to become pregnant during the course of the study.

  14. Is being treated for hyperthyroidism at time of screening.

  15. Has diagnosis of adrenal insufficiency at time of screening.

  16. Has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeksfrom time of screening visit, or plans to take any oral, injectable, or IVglucocorticoids during the course of the study. Note: Intra-articular injections to treat pain (e.g., joint pain, bursitis, etc.)are permitted

  17. Is using hydroxyurea at time of screening or plans to use it during the study.

  18. Is actively participating in an investigational study (drug or device) whereinhe/she has received treatment from an investigational study drug or investigationalstudy device in the last 2 weeks prior to screening.(Note: Did not apply to subjectswho transitioned from Phase 1 to Phase 2)

  19. Is currently abusing illicit drugs.

  20. Is currently abusing marijuana.

  21. Is currently abusing prescription drugs.

  22. Is currently abusing alcohol.

  23. Has a history of visual impairment which would not allow subject to participate inthe study and perform all study procedures safely, as determined by theinvestigator.

  24. Has elective surgery planned that requires general anesthesia during the course ofthe study.

  25. Has sickle cell disease, hemoglobinopathy; or has received red blood celltransfusion or erythropoietin within 3 months prior to time of screening.

  26. Plans to receive red blood cell transfusion or erythropoietin over the course ofstudy participation.

  27. Is diagnosed with current eating disorder such as anorexia or bulimia.

  28. Has been diagnosed with chronic kidney disease greater than CKD2 that results inchronic anemia.

  29. Has a hematocrit that is below the normal reference range of lab used.

  30. Is on dialysis.

  31. Has serum creatinine of >2 mg/dL.

  32. Has celiac disease that is not adequately treated as determined by the investigator.

  33. Has had any of the following cardiovascular events within 1 year of screening:myocardial infarction, unstable angina, coronary artery bypass surgery, coronaryartery stenting, transient ischemic attack, cerebrovascular accident, angina,congestive heart failure, or ventricular rhythm disturbances.

  34. Has had any of the following cardiovascular events 1 year or more prior toscreening: Myocardial infarction, unstable angina, coronary artery bypass surgery,coronary artery stenting, transient ischemic attack, cerebrovascular accident,angina, congestive heart failure, or ventricular rhythm disturbances. Subject may beenrolled if clearance from a board-certified cardiologist is provided prior to or atScreening.

  35. Is a member of the research staff involved with the study.

  36. Has used a MiniMed 780G pump prior to screening (Note: In Phase 2, this applies tonew subjects only).

Study Design

Total Participants: 574
Treatment Group(s): 1
Primary Treatment: MiniMed™ 780G Insulin Pump system
Phase:
Study Start date:
February 25, 2022
Estimated Completion Date:
January 11, 2025

Study Description

Phase 1 of the study, will utilize the MiniMed™ 780G Insulin pump with Guardian 4 sensor for the run-in period, study period, and optional continued access. Phase 2 of the study will utilize the MiniMed™ 780G BLE2.0 insulin pump with the Disposable Sensor 5 for the run-in period and study period which will be approximately 135 days long. A total of up to 575 subjects with at least 300 subjects entering the study period of Phase 2, with insulin-requiring diabetes age 18-80 will be enrolled at up to 40 investigational centers across the United States.

Connect with a study center

  • Medical Investigations

    Little Rock, Arkansas 72211
    United States

    Site Not Available

  • Headlands Research California LLC

    Escondido, California 92025
    United States

    Site Not Available

  • Loma Linda University Medical Center

    Loma Linda, California 92354
    United States

    Site Not Available

  • Hoag Hospital Newport Beach

    Newport Beach, California 92663
    United States

    Site Not Available

  • Mills-Peninsula Medical Center: Diabetes Research Institute

    San Mateo, California 94401
    United States

    Site Not Available

  • Sansum Diabetes Research Institute

    Santa Barbara, California 93105
    United States

    Site Not Available

  • East Coast Institute for Research

    Jacksonville, Florida 32204
    United States

    Site Not Available

  • USF Diabetes Center

    Tampa, Florida 33612
    United States

    Site Not Available

  • Atlanta Diabetes Associates

    Atlanta, Georgia 30318
    United States

    Site Not Available

  • East Coast Institute for Research

    Canton, Georgia 30114
    United States

    Site Not Available

  • East Coast Institute for Research

    Macon, Georgia 31210
    United States

    Site Not Available

  • Endocrine Research Solutions

    Roswell, Georgia 30076
    United States

    Site Not Available

  • Javara

    Thomasville, Georgia 31792
    United States

    Site Not Available

  • NorthShore University Health System

    Skokie, Illinois 60077
    United States

    Site Not Available

  • Iowa Diabetes Research

    West Des Moines, Iowa 50265
    United States

    Site Not Available

  • MedStar Good Samaritan Hospital

    Baltimore, Maryland 21239
    United States

    Site Not Available

  • Endocrine & Metabolic Consultants

    Rockville, Maryland 20852
    United States

    Site Not Available

  • Park Nicollet International Diabetes Center

    Saint Louis Park, Minnesota 55416
    United States

    Site Not Available

  • Bryan Health

    Lincoln, Nebraska 68506
    United States

    Site Not Available

  • Atlantic Health System

    Morristown, New Jersey 07962
    United States

    Site Not Available

  • NYC Research Inc

    Long Island City, New York 11106
    United States

    Site Not Available

  • Northwell Health Physician Partners Endocrinology

    New York, New York 10022
    United States

    Site Not Available

  • Physicians East

    Greenville, North Carolina 27834
    United States

    Site Not Available

  • Texas Diabetes and Endocrinology

    Austin, Texas 78731
    United States

    Site Not Available

  • Javara

    Conroe, Texas 77384
    United States

    Site Not Available

  • Velocity Clinical Research

    Dallas, Texas 75230
    United States

    Site Not Available

  • Prime Revival Research Institute

    Flower Mound, Texas 75028
    United States

    Site Not Available

  • Houston Methodist Research Institute

    Houston, Texas 77030
    United States

    Site Not Available

  • Tekton Research

    McKinney, Texas 75069
    United States

    Site Not Available

  • Virginia Endocrinology Research

    Chesapeake, Virginia 23321
    United States

    Site Not Available

  • Rainier Clinical Research Center

    Renton, Washington 98057
    United States

    Site Not Available

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