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
NCT ID: NCT05238142
Last Updated: 2025-02-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
574 participants
INTERVENTIONAL
2022-02-25
2025-01-11
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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)
Interventions
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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)
Eligibility Criteria
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Inclusion Criteria
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. 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).
18 Years
80 Years
ALL
No
Sponsors
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Medtronic Diabetes
INDUSTRY
Responsible Party
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Locations
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Medical Investigations
Little Rock, Arkansas, United States
Headlands Research California LLC
Escondido, California, United States
Loma Linda University Medical Center
Loma Linda, California, United States
Hoag Hospital Newport Beach
Newport Beach, California, United States
Mills-Peninsula Medical Center: Diabetes Research Institute
San Mateo, California, United States
Sansum Diabetes Research Institute
Santa Barbara, California, United States
East Coast Institute for Research
Jacksonville, Florida, United States
USF Diabetes Center
Tampa, Florida, United States
Atlanta Diabetes Associates
Atlanta, Georgia, United States
East Coast Institute for Research
Canton, Georgia, United States
East Coast Institute for Research
Macon, Georgia, United States
Endocrine Research Solutions
Roswell, Georgia, United States
Javara
Thomasville, Georgia, United States
NorthShore University Health System
Skokie, Illinois, United States
Iowa Diabetes Research
West Des Moines, Iowa, United States
MedStar Good Samaritan Hospital
Baltimore, Maryland, United States
Endocrine & Metabolic Consultants
Rockville, Maryland, United States
Park Nicollet International Diabetes Center
Saint Louis Park, Minnesota, United States
Bryan Health
Lincoln, Nebraska, United States
Atlantic Health System
Morristown, New Jersey, United States
NYC Research Inc
Long Island City, New York, United States
Northwell Health Physician Partners Endocrinology
New York, New York, United States
Physicians East
Greenville, North Carolina, United States
Texas Diabetes and Endocrinology
Austin, Texas, United States
Javara
Conroe, Texas, United States
Velocity Clinical Research
Dallas, Texas, United States
Prime Revival Research Institute
Flower Mound, Texas, United States
Houston Methodist Research Institute
Houston, Texas, United States
Tekton Research
McKinney, Texas, United States
Virginia Endocrinology Research
Chesapeake, Virginia, United States
Rainier Clinical Research Center
Renton, Washington, United States
Countries
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Other Identifiers
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CIP341
Identifier Type: -
Identifier Source: org_study_id
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