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Safety and Effectiveness of the MiniMed™ 780G System With DS5 CGM

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05714059
Recruitment Status : Completed
First Posted : February 6, 2023
Last Update Posted : January 12, 2024
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes

Tracking Information
First Submitted Date  ICMJE January 26, 2023
First Posted Date  ICMJE February 6, 2023
Last Update Posted Date January 12, 2024
Actual Study Start Date  ICMJE February 28, 2023
Actual Primary Completion Date December 29, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 26, 2023)
  • Primary Safety Endpoint for Age 18-80 - Change in HbA1c [ Time Frame: 3 months ]
    Age 18-80: The overall mean change in HbA1c from baseline to end of 3-month study period. Non-inferiority test.
  • Primary Safety Endpoint for Age 7-17 - Change in HbA1c [ Time Frame: 3 months ]
    Age 7-17: The overall mean change in HbA1c from baseline to end of 3-month study period. Non-inferiority test.
  • Primary Effectiveness Endpoint for Age 18-80 - Percent of Time in Range (TIR 70-180 mg/dL) [ Time Frame: 3 months ]
    Age 18-80: The mean % of time in range (TIR 70-180 mg/dL). Non-inferiority test.
  • Primary Effectiveness Endpoint for Age 7-17 - Percent of Time in Range (TIR 70-180 mg/dL) [ Time Frame: 3 months ]
    Age 7-17: The mean % of time in range (TIR 70-180 mg/dL). Non-inferiority test.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 26, 2023)
  • Secondary Effectiveness Endpoint 1 for Age 18-80 - Percent of Time in Hypoglycemia (< 54 mg/dL) [ Time Frame: 3 months ]
    Age 18-80: The mean % of time in hypoglycemia (< 54 mg/dL) . Non-inferiority test.
  • Secondary Effectiveness Endpoint 1 for Age 7-17 - Percent of Time in Hypoglycemia (< 54 mg/dL) [ Time Frame: 3 months ]
    Age 7-17: The mean % of time in hypoglycemia (< 54 mg/dL). Non-inferiority test.
  • Secondary Effectiveness Endpoint 2 for Age 18-80 - Percent of Time in Range (TIR 70-180 mg/dL) [ Time Frame: 3 months ]
    Age 18-80: The mean % of time in range (TIR 70-180 mg/dL).Superiority test.
  • Secondary Effectiveness Endpoint 2 for Age 7-17 - Percent of Time in Range (TIR 70-180 mg/dL) [ Time Frame: 3 months ]
    Age 7-17: The mean % of time in range (TIR 70-180 mg/dL ).Superiority test.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Effectiveness of the MiniMed™ 780G System With DS5 CGM
Official Title  ICMJE Safety and Effectiveness Evaluation of the MiniMed™ 780G System Used in Combination With the DS5 CGM
Brief Summary The purpose of this study is to confirm the safety and effectiveness of the MiniMed 780G insulin pump used in combination with the DS5 CGM in type 1 diabetes adult and pediatric subjects in a home setting.
Detailed Description This study is a multi-center, single arm study in insulin-requiring adult and pediatric subjects with type 1 diabetes on the MiniMed 780G system using DS5 as well as Medtronic Extended infusion set and reservoir. The run-in period and study period will be approximately 120 days long.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Type 1 Diabetes
Intervention  ICMJE Device: Insulin Pump with Continuous Glucose Monitoring
MiniMed™ 780G insulin pump in combination with the DS5 CGM
Study Arms  ICMJE Experimental: MiniMed™ 780G system with DS5
Subjects with type 1 diabetes wearing the MiniMed™ 780G insulin pump in combination with the DS5 CGM.
Intervention: Device: Insulin Pump with Continuous Glucose Monitoring
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 26, 2023)
250
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 29, 2023
Actual Primary Completion Date December 29, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Age 7 - 80 years at time of screening.
  2. Has a clinical diagnosis of type 1 diabetes:

    1. 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.
    2. 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.
  3. Does not require a legally authorized representative to consent on their behalf due to mental or intellectual disability.
  4. Subject or parent/caregiver is literate and able to read the language offered in the pump or pump materials.
  5. Subject and/or legally authorized representative is willing to provide informed consent for participation.
  6. Is willing to perform fingerstick blood glucose measurements as needed.
  7. Is willing to wear the system continuously throughout the study.
  8. Must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units.
  9. Has a Glycosylated hemoglobin (HbA1c) less than 10% (as processed by Central Lab) at time of screening visit.
  10. 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.
  11. Uses pump therapy for greater than 6 months prior to screening (with or without CGM experience).
  12. 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.
  13. 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 (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 DKA 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).
  6. Is female of child-bearing potential and result of pregnancy test is positive at screening.
  7. Is sexually active female of child-bearing potential and is not using a form of contraception deemed reliable by the investigator.
  8. Is female and plans to become pregnant during the course of the study.
  9. Is being treated for hyperthyroidism at time of screening.
  10. Has diagnosis of adrenal insufficiency.
  11. 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.
  12. Is using hydroxyurea at time of screening or plans to use it during the study.
  13. 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.
  14. Has used a MiniMed 780G pump prior to screening.
  15. Is currently abusing illicit drugs.
  16. Is currently abusing marijuana.
  17. Is currently abusing prescription drugs.
  18. Is currently abusing alcohol.
  19. Using pramlintide (Symlin), DPP-4 inhibitor, liraglutide (Victoza or other GLP-1 agonists), metformin, canagliflozin (Invokana or other SGLT2 inhibitors) at time of screening.
  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 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 history of cardiovascular event 1 year or more from the time of screening without

    1. a normal EKG and stress test within 6 months prior to screening or during screening or
    2. clearance from a qualified physician prior to receiving the study devices if there is an abnormal EKG or stress test.
  32. Has 3 or more cardiovascular risk factors listed below without a normal EKG within 6 months prior to screening or during screening or clearance from a qualified physician if there is an abnormal EKG:

    • Age >35 years
    • Type 1 diabetes of >15 years' duration
    • Presence of any additional risk factor for coronary artery disease
    • Presence of microvascular disease (proliferative retinopathy or nephropathy, including microalbuminuria)
    • Presence of peripheral vascular disease
    • Presence of autonomic neuropathy
  33. Is a member of the research staff involved with the study.
  34. Is a Medtronic Diabetes employee or their immediate family member (excluding adult children and/or adult siblings).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 7 Years to 80 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05714059
Other Study ID Numbers  ICMJE CIP337
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Medtronic Diabetes
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Medtronic Diabetes
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Medtronic Diabetes
Verification Date January 2024

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP