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

February 15, 2024 updated by: Medtronic Diabetes

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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 at least 500 subjects with at least 300 subjects entering Phase 2, with insulin-requiring diabetes age 18-80 will be enrolled at up to 40 investigational centers across the United States.

Study Type

Interventional

Enrollment (Estimated)

500

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Recruiting
        • Medical Investigations
        • Contact:
        • Principal Investigator:
          • James Thrasher, MD
    • California
      • Escondido, California, United States, 92025
        • Recruiting
        • Headlands Research California LLC
        • Contact:
        • Principal Investigator:
          • Timothy Bailey, MD
      • Loma Linda, California, United States, 92354
        • Recruiting
        • Loma Linda University Medical Center
        • Contact:
          • Christian Cordero
          • Phone Number: 909-558-3022
        • Principal Investigator:
          • Scott Lee, MD
      • Newport Beach, California, United States, 92663
        • Recruiting
        • Hoag Hospital Newport Beach
        • Contact:
        • Principal Investigator:
          • David Ahn, MD
      • Santa Barbara, California, United States, 93105
        • Recruiting
        • Sansum Diabetes Research Institute
        • Principal Investigator:
          • Kristin Castorino, DO
        • Contact:
    • Florida
      • Jacksonville, Florida, United States, 32204
      • Tampa, Florida, United States, 33612
        • Recruiting
        • USF Diabetes Center
        • Principal Investigator:
          • Dorothy Shulman, MD
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Recruiting
        • Atlanta Diabetes Associates
        • Principal Investigator:
          • Bruce Bode, MD
        • Contact:
      • Canton, Georgia, United States, 30114
      • Macon, Georgia, United States, 31210
      • Roswell, Georgia, United States, 30076
        • Recruiting
        • Endocrine Research Solutions
        • Contact:
          • Jessica Tapia
          • Phone Number: 678-878-4750
        • Principal Investigator:
          • John Reed, MD
      • Thomasville, Georgia, United States, 31792
    • Illinois
      • Skokie, Illinois, United States, 60077
        • Recruiting
        • NorthShore University Health System
        • Principal Investigator:
          • Liana Billings, MD
        • Contact:
    • Iowa
      • West Des Moines, Iowa, United States, 50265
        • Recruiting
        • Iowa Diabetes Research
        • Principal Investigator:
          • Anuj Bhargava, MD
        • Contact:
          • Allie Fowler
          • Phone Number: 515-329-6800
    • Maryland
      • Baltimore, Maryland, United States, 21239
        • Recruiting
        • MedStar Good Samaritan Hospital
        • Contact:
        • Principal Investigator:
          • Jean Park, MD
      • Rockville, Maryland, United States, 20852
        • Recruiting
        • Endocrine & Metabolic Consultants
        • Principal Investigator:
          • Michael Dempsey, MD
        • Contact:
    • Minnesota
    • Nebraska
      • Lincoln, Nebraska, United States, 68506
    • New Jersey
      • Morristown, New Jersey, United States, 07962
    • New York
      • Long Island City, New York, United States, 11106
        • Recruiting
        • NYC Research INC
        • Contact:
        • Principal Investigator:
          • Anastasios Manessis, MD
      • New York, New York, United States, 10022
        • Recruiting
        • Northwell Health Physician Partners Endocrinology
        • Contact:
        • Principal Investigator:
          • Leonid Poretsky, MD
    • North Carolina
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • Physicians East
        • Contact:
          • Kirsten Taylor - Goff
          • Phone Number: 252-413-6299
        • Principal Investigator:
          • Mark Warren, MD
    • Texas
      • Austin, Texas, United States, 78731
        • Recruiting
        • Texas Diabetes and Endocrinology
        • Principal Investigator:
          • Luis Casaubon, MD
        • Contact:
      • Conroe, Texas, United States, 77384
      • Dallas, Texas, United States, 75230
      • Flower Mound, Texas, United States, 75028
        • Recruiting
        • Prime Revival Research Institute
        • Contact:
        • Principal Investigator:
          • Wasim Haque, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Research Institute
        • Contact:
        • Principal Investigator:
          • Abhishek Kansara, MD
      • McKinney, Texas, United States, 75069
    • Virginia
      • Chesapeake, Virginia, United States, 23321
        • Recruiting
        • Virginia Endocrinology Research
        • Principal Investigator:
          • James LaRocque, MD
        • Contact:
    • Washington
      • Renton, Washington, United States, 98057
        • Recruiting
        • Rainier Clinical Research Center
        • Principal Investigator:
          • Frances Broyles, MD
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 via medical record or source documentation by an individual qualified to make a medical diagnosis.
  3. Is on MDI regimen (basal/bolus regimen with long-acting insulin and rapid-acting analogs), defined as greater than or equal to 2 injections per day for at least 3 months prior signing the informed consent, or CSII pump therapy with or without CGM. The investigator will use their discretion to verify that insulin requirements have been 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 due to 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 National Glycohemoglobin Standardization Program (NGSP) certified Central Laboratory. HbA1c testing must follow NGSP standards.

  9. 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.
  10. 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.

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

    1. Humalog (insulin lispro injection)
    2. NovoLog/NovoRapid (insulin aspart injection)
    3. Admelog (insulin lispro injection)

Exclusion Criteria:

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

    1. Medical assistance (i.e., Paramedics, Emergency Room [ER] or Hospitalization)
    2. Coma
    3. Seizures
  2. Has been hospitalized or has visited the ER in the 6 months prior to screening resulting in a primary diagnosis of uncontrolled diabetes.
  3. Has had diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar syndrome (HHS) in the last 6 months prior to screening visit.
  4. Will not tolerate tape adhesive in the area of sensor placement as assessed by a qualified individual.
  5. Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection) at time of screening.
  6. Has (Total Daily Dose) of less than 8 units or greater than 250 units at time of screening.
  7. Has positive GAD (Glutamic Acid Decarboxylase) Antibody test
  8. Is female of child-bearing potential and result of pregnancy test is positive at screening
  9. Is sexually active female of child-bearing potential and is not using a form of contraception deemed reliable by the investigator.
  10. Is female and plans to become pregnant during the course of the study.
  11. Is being treated for hyperthyroidism at time of screening.
  12. Has diagnosis of adrenal insufficiency at time of screening.

  13. 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 glucocorticoids during the course of the study.

    Note: Intra-articular injections to treat pain (e.g., joint pain, bursitis, etc.) are permitted

  14. Is using hydroxyurea at time of screening or plans to use it during the study.
  15. 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 prior to screening.(Note: Did not apply to subjects who transitioned from Phase 1 to Phase 2)
  16. Is currently abusing illicit drugs.
  17. Is currently abusing marijuana.
  18. Is currently abusing prescription drugs.
  19. Is currently abusing alcohol.
  20. 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.
  21. Has elective surgery planned that requires general anesthesia during the course of the study.
  22. Has sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening.
  23. Plans to receive red blood cell transfusion or erythropoietin over the course of study participation.
  24. Is diagnosed with current eating disorder such as anorexia or bulimia.
  25. Has been diagnosed with chronic kidney disease greater than CKD2 that results in chronic anemia.
  26. Has a hematocrit that is below the normal reference range of lab used.
  27. Is on dialysis.
  28. Has serum creatinine of >2 mg/dL.
  29. Has celiac disease that is not adequately treated as determined by the investigator.
  30. Has had any of the following cardiovascular events within 1 year of screening: myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances.
  31. Has had any of the following cardiovascular events 1 year or more prior to screening: 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 be enrolled if clearance from a board-certified cardiologist is provided prior to or at Screening.
  32. Is a member of the research staff involved with the study.
  33. Has used a MiniMed 780G pump prior to screening (Note: In Phase 2, this applies to new subjects only).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: MiniMed 780G System
Adult participants with insulin-requiring type 2 diabetes age 18-80 using the MiniMed 780G system for a combined run-in period and study period will be approximately 135 days long.
Device: MiniMed™ 780G Insulin Pump system
MiniMed 780G insulin pump with Guardian 4 sensor (phase 1) MiniMed™ 780G BLE 2.0 insulin pump used in combination with Disposable Sensor 5 (phase 2)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary Safety Endpoint - Change in HbA1c
Time Frame: 3 months
The overall mean change in HbA1c from baseline to end of 3-month study period. Non-inferiority test.
3 months
Primary Effectiveness Endpoint - Percent of time in range (TIR 70-180 mg/dL)
Time Frame: 3 months
The mean percent of time in range (TIR 70-180 mg/dL). Non-inferiority test.
3 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Secondary Effectiveness Endpoint - Percent of time in range (TIR 70-180 mg/dL)
Time Frame: 3 months
The mean percent of time in range (TIR 70-180 mg/dL). Superiority test.
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medtronic Diabetes

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 25, 2022

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

November 1, 2025

Study Registration Dates

First Submitted

February 3, 2022

First Submitted That Met QC Criteria

February 3, 2022

First Posted (Actual)

February 14, 2022

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 15, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CIP341

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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