Phase
Condition
Diabetes And Hypertension
Diabetes Prevention
Diabetes Mellitus, Type 2
Treatment
MiniMed™ 780G Insulin Pump system
Clinical Study ID
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Is age 18 - 80 years at time of screening.
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.
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.
Is able to comply with technology, according to Investigator's judgment
Does not require a legally authorized representative to consent on their behalf dueto mental or intellectual disability.
Is willing to perform fingerstick blood glucose measurements as needed.
Is willing to wear the system continuously throughout the study.
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.
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.
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.
Is willing to take one of the following insulins and can financially support the useof insulin preparations as required by the study:
Humalog (insulin lispro injection)
NovoLog/NovoRapid (insulin aspart injection)
Admelog (insulin lispro injection)
Exclusion
Exclusion Criteria:
Has a history of 2 or more episodes of severe hypoglycemia, which resulted in anythe 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 screeningresulting in a primary diagnosis of uncontrolled diabetes.
Has had diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar syndrome (HHS) inthe last 6 months prior to screening visit.
Will not tolerate tape adhesive in the area of sensor placement as assessed by aqualified individual.
Has any unresolved adverse skin condition in the area of sensor placement (e.g.,psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection) at time ofscreening.
Has (Total Daily Dose) of less than 8 units or greater than 250 units at time ofscreening.
Has positive GAD (Glutamic Acid Decarboxylase) Antibody test
Is female of child-bearing potential and result of pregnancy test is positive atscreening
Is sexually active female of child-bearing potential and is not using a form ofcontraception 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 at time of screening.
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
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) 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)
Is currently abusing illicit drugs.
Is currently abusing marijuana.
Is currently abusing prescription drugs.
Is currently abusing alcohol.
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.
Has elective surgery planned that requires general anesthesia during the course ofthe study.
Has sickle cell disease, hemoglobinopathy; or has received red blood celltransfusion or erythropoietin within 3 months prior to time of screening.
Plans to receive red blood cell transfusion or erythropoietin over the course ofstudy participation.
Is diagnosed with current eating disorder such as anorexia or bulimia.
Has been diagnosed with chronic kidney disease greater than CKD2 that results inchronic anemia.
Has a hematocrit that is below the normal reference range of lab used.
Is on dialysis.
Has serum creatinine of >2 mg/dL.
Has celiac disease that is not adequately treated as determined by the investigator.
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.
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.
Is a member of the research staff involved with the study.
Has used a MiniMed 780G pump prior to screening (Note: In Phase 2, this applies tonew subjects only).
Study Design
Study Description
Connect with a study center
Medical Investigations
Little Rock, Arkansas 72211
United StatesSite Not Available
Headlands Research California LLC
Escondido, California 92025
United StatesSite Not Available
Loma Linda University Medical Center
Loma Linda, California 92354
United StatesSite Not Available
Hoag Hospital Newport Beach
Newport Beach, California 92663
United StatesSite Not Available
Mills-Peninsula Medical Center: Diabetes Research Institute
San Mateo, California 94401
United StatesSite Not Available
Sansum Diabetes Research Institute
Santa Barbara, California 93105
United StatesSite Not Available
East Coast Institute for Research
Jacksonville, Florida 32204
United StatesSite Not Available
USF Diabetes Center
Tampa, Florida 33612
United StatesSite Not Available
Atlanta Diabetes Associates
Atlanta, Georgia 30318
United StatesSite Not Available
East Coast Institute for Research
Canton, Georgia 30114
United StatesSite Not Available
East Coast Institute for Research
Macon, Georgia 31210
United StatesSite Not Available
Endocrine Research Solutions
Roswell, Georgia 30076
United StatesSite Not Available
Javara
Thomasville, Georgia 31792
United StatesSite Not Available
NorthShore University Health System
Skokie, Illinois 60077
United StatesSite Not Available
Iowa Diabetes Research
West Des Moines, Iowa 50265
United StatesSite Not Available
MedStar Good Samaritan Hospital
Baltimore, Maryland 21239
United StatesSite Not Available
Endocrine & Metabolic Consultants
Rockville, Maryland 20852
United StatesSite Not Available
Park Nicollet International Diabetes Center
Saint Louis Park, Minnesota 55416
United StatesSite Not Available
Bryan Health
Lincoln, Nebraska 68506
United StatesSite Not Available
Atlantic Health System
Morristown, New Jersey 07962
United StatesSite Not Available
NYC Research Inc
Long Island City, New York 11106
United StatesSite Not Available
Northwell Health Physician Partners Endocrinology
New York, New York 10022
United StatesSite Not Available
Physicians East
Greenville, North Carolina 27834
United StatesSite Not Available
Texas Diabetes and Endocrinology
Austin, Texas 78731
United StatesSite Not Available
Javara
Conroe, Texas 77384
United StatesSite Not Available
Velocity Clinical Research
Dallas, Texas 75230
United StatesSite Not Available
Prime Revival Research Institute
Flower Mound, Texas 75028
United StatesSite Not Available
Houston Methodist Research Institute
Houston, Texas 77030
United StatesSite Not Available
Tekton Research
McKinney, Texas 75069
United StatesSite Not Available
Virginia Endocrinology Research
Chesapeake, Virginia 23321
United StatesSite Not Available
Rainier Clinical Research Center
Renton, Washington 98057
United StatesSite Not Available
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