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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 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05238142
Recruitment Status : Recruiting
First Posted : February 14, 2022
Last Update Posted : August 9, 2022
Sponsor:
Information provided by (Responsible Party):
Medtronic Diabetes

Brief Summary:
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. At the conclusion of the 90-day study period, subjects will be given the opportunity to transition to a period of continued access. They will be allowed to continue using the study device system until further notice from Sponsor.

Condition or disease Intervention/treatment Phase
Type 2 Diabetes Treated With Insulin Device: MiniMed™ 780G Insulin Pump system Not Applicable

Detailed Description:
A total of at least 300 subjects with insulin-requiring type 2 diabetes age 18-80 will be enrolled at up to 25 investigational centers across the United States, using the 780 insulin pump in combination with Guardian 4 sensor and Guardian 4 transmitter.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : February 25, 2022
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : May 2023

Resource links provided by the National Library of Medicine


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. At the conclusion of the 90-day study period, subjects will be given the opportunity to transition to a period of continued access.
Device: MiniMed™ 780G Insulin Pump system
780 insulin pump used in combination with Guardian 4 sensor and Guardian 4 transmitter




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  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 history of cardiovascular event 1 year or more from the time of screening without c. a normal EKG and stress test within 6 months prior to screening or during screening or d. clearance from a qualified physician prior to receiving the study devices if there is an abnormal EKG or stress test.
  32. Is a member of the research staff involved with the study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05238142


Contacts
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Contact: Tom Troub 8185763142 thomas.troub@medtronic.com
Contact: Briggitte Marinos 8185765373 briggitte.s.marinos@medtronic.com

Locations
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United States, Arkansas
Medical Investigations Recruiting
Little Rock, Arkansas, United States, 72211
Contact: Lesa Thrasher, RRT    501-666-3666    lesathrasher@yahoo.com   
Principal Investigator: James Thrasher, MD         
United States, Florida
East Coast Institute for Research Recruiting
Jacksonville, Florida, United States, 32204
Contact: Matt Taddeo       Matt.taddeo@eastcoastresearch.net   
Principal Investigator: David Sutton, MD         
USF Diabetes Center Not yet recruiting
Tampa, Florida, United States, 33612
Contact: Dorothy Shulman, MD         
United States, Georgia
Atlanta Diabetes Associates Recruiting
Atlanta, Georgia, United States, 30318
Contact: Natalie Price       NPrice@atlantadiabetes.com   
Principal Investigator: Bruce Bode, MD         
East Coast Institute for Research Recruiting
Canton, Georgia, United States, 30114
Contact: Amber Hurst    678-785-9600    amber.hurst@eastcoastresearch.net   
Contact: Alicia Green       alicia.green@eastcoastresearch.net   
Principal Investigator: Jason Berner, MD         
East Coast Institute for Research Recruiting
Macon, Georgia, United States, 31210
Contact: Lindsay Alexander    478-219-2017    lindsay.alexander@eastcoastresearch.net   
Principal Investigator: Thomas C Jones, MD         
Endocrine Research Solutions Recruiting
Roswell, Georgia, United States, 30076
Contact: Jessica Tapia    678-878-4750      
Principal Investigator: John Reed, MD         
United States, Iowa
Iowa Diabetes Research Recruiting
West Des Moines, Iowa, United States, 50265
Contact: Lisa Borg       lborg@iderc.com   
Principal Investigator: Anuj Bhargava, MD         
United States, Minnesota
Park Nicollet International Diabetes Center Not yet recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Richard Bergenstal, MD         
United States, North Carolina
Physicians East Recruiting
Greenville, North Carolina, United States, 27834
Contact: Kirsten Taylor - Goff    252-413-6299      
Principal Investigator: Mark Warren, MD         
United States, Washington
Rainier Clinical Research Center Recruiting
Renton, Washington, United States, 98057
Contact: Laura Andreas, MD       landreas@rainier-research.com   
Principal Investigator: Ronald Brazg, MD         
Sponsors and Collaborators
Medtronic Diabetes
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Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT05238142    
Other Study ID Numbers: CIP341
First Posted: February 14, 2022    Key Record Dates
Last Update Posted: August 9, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs