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Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adults and Pediatrics Utilizing Lyumjev®

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: NCT05325294
Recruitment Status : Recruiting
First Posted : April 13, 2022
Last Update Posted : May 11, 2022
Sponsor:
Collaborator:
Eli Lilly and Company
Information provided by (Responsible Party):
Medtronic Diabetes

Brief Summary:
This US study will evaluate the safety of utilizing Lyumjev® insulin lispro-aabc in the MiniMed™ 780G System in Type 1 adult and pediatric subjects in a home setting to support product and system labeling.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Device: MiniMed 780G System Not Applicable

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 Lyumjev® insulin lispro-aabc and Medtronic Extended infusion set and reservoir. The run-in period and study period will be approximately 120 days long.

A total of up to 250 subjects with insulin-requiring type 1 diabetes age 2-80 will be enrolled at up to 18 investigational centers across the United States in order to have at least 200 subjects enter the study period. Up to 125 subjects will be enrolled in the pediatric age group (2-17 years of age) and up to 125 in the adult age group (18 years or older).

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 250 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adult and Pediatric Subjects Utilizing Lyumjev® Insulin Lispro-aabc
Actual Study Start Date : May 5, 2022
Estimated Primary Completion Date : May 31, 2023
Estimated Study Completion Date : May 31, 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin

Arm Intervention/treatment
Experimental: MiniMed 780G System Utilizing Insulin Lyumjev®
Subjects with insulin-requiring type 1 diabetes age 2-80 using the MiniMed 780G system with Insulin Lyumjev® for a period of three months.
Device: MiniMed 780G System
MiniMed™ 780G Insulin Pump, Guardian™ 4 Glucose Sensor, and Guardian 4 Transmitter; used with Insulin Lyumjev® insulin lispro-aabc




Primary Outcome Measures :
  1. 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.

  2. Primary Safety Endpoint for Age 2-17 - Change in HbA1c [ Time Frame: 3 months ]
    Age 2-17: The overall mean change in HbA1c from baseline to end of 3-month study period. Non-inferiority test.

  3. 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 [3.9 -10.0 mmol/L]). Non-inferiority test.

  4. Primary Effectiveness Endpoint for Age 2-17 - 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 [3.9 -10.0 mmol/L]). Non-inferiority test.


Secondary Outcome Measures :
  1. 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 [3.0 mmol/L]). Non-inferiority test

  2. Secondary Effectiveness Endpoint 1 for Age 2-17 - Percent of Time in Hypoglycemia (< 54 mg/dL) [ Time Frame: 3 months ]
    Age 2-17: The mean % of time in hypoglycemia (< 54 mg/dL [3.0 mmol/L]). Non-inferiority test

  3. 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 [3.9 -10.0 mmol/L]).Superiority test.

  4. Secondary Effectiveness Endpoint 2 for Age 2-17 - Percent of Time in Range (TIR 70-180 mg/dL) [ Time Frame: 3 months ]
    Age 2-17: The mean % of time in range (TIR 70-180 mg/dL [3.9 -10.0 mmol/L]).Superiority test.



Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 80 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age 2-80 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. 2-6 years of age: A clinical diagnosis of type 1 diabetes for 6 months or more, as determined via medical record/ 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.

    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.

  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 prior to screening:

    1. 7-80 years of age: greater than 6 months prior to screening (with or without CGM experience)
    2. 2-6 years of age: greater than 3 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 either of the 2 insulin preparations as required during the run-in period:

    1. Humalog (insulin lispro injection)
    2. NovoLog (insulin aspart injection)
  14. Is willing to take Lyumjev insulin during the study period (supplied via Sponsor).

Exclusion Criteria:

  1. Has hypersensitivity to insulin lispro or one of the excipients in Lyumjev®
  2. 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
  3. Has been hospitalized or has visited the ER in the 6 months prior to screening resulting in a primary diagnosis of uncontrolled diabetes.
  4. Has had DKA in the last 6 months prior to screening visit.
  5. Will not tolerate tape adhesive in the area of sensor placement as assessed by a qualified individual.
  6. Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
  7. Is female of child-bearing potential and result of pregnancy test is positive at screening.
  8. Is sexually active female of child-bearing potential and is not using a form of contraception deemed reliable by the investigator.
  9. Is female and plans to become pregnant during the course of the study.
  10. Is being treated for hyperthyroidism at time of screening.
  11. Has diagnosis of adrenal insufficiency.
  12. 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 glucocorticoid during the course of the study.
  13. Is using hydroxyurea at time of screening or plans to use it during the study.
  14. 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.
  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.

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): NCT05325294


Contacts
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Contact: Thomas Troub 818 576 3142 thomas.troub@medtronic.com
Contact: Shannon Bondy 818 576 4912 shannon.bondy@medtronic.com

Locations
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United States, California
Valley Research Not yet recruiting
Fresno, California, United States, 93729
Contact: Lucas Anderson       luke.anderson@fresnoresearch.com   
Principal Investigator: Paul Norwood, MD         
Stanford University Not yet recruiting
Palo Alto, California, United States, 94304
Contact: Eliana A Frank       elianaf@stanford.edu   
Principal Investigator: Rayhan Lal, MD         
Rady Children's Hospital San Diego Not yet recruiting
San Diego, California, United States, 92123
Contact: Marla Hashiguchi       mhashiguchi@rchsd.org   
Principal Investigator: Carla Demeterco-Berggren, MD         
United States, Colorado
Barbara Davis Center Recruiting
Aurora, Colorado, United States, 80045
Contact: Ashleigh Downs       ashleigh.downs@cuanschutz.edu   
Principal Investigator: Halis Kaan Akturk, MD         
United States, Connecticut
Yale University Not yet recruiting
New Haven, Connecticut, United States, 06511
Contact: Lori Carria       lori.carria@yale.edu   
Principal Investigator: Laura Nally, MD         
United States, Florida
University of South Florida Diabetes Center Not yet recruiting
Tampa, Florida, United States, 33612
Contact: Janet Rodriguez       janetrodriguez@health.usf.edu   
Principal Investigator: Dorothy Shulman, MD         
United States, Georgia
Atlanta Diabetes Not yet recruiting
Atlanta, Georgia, United States, 30318
Contact: Anna Busby       abusby@atlantadiabetes.com   
Principal Investigator: Bruce Bode, MD         
East Coast Institute for Research - Macon Not yet recruiting
Macon, Georgia, United States, 31210
Contact: Alicia Green       alicia.green@eastcoastresearch.net   
Principal Investigator: Thomas Jones, MD         
Endorcine Research Solutions Not yet recruiting
Roswell, Georgia, United States, 30076
Contact: Jessica Tapia       jtapia.ers@gmail.com   
Principal Investigator: John Reed, MD         
United States, Idaho
Rocky Mountain Recruiting
Idaho Falls, Idaho, United States, 83404
Contact: Kelsie Landon       kelsie.landon@idahomed.com   
Principal Investigator: David Liljenquist, MD         
United States, Minnesota
Mayo Clinic Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Shelly McCrady-Spitzer       McCradySpitzer.Shelly@mayo.edu   
Principal Investigator: Yogish Kudva, MD         
International Diabetes Center Not yet recruiting
Saint Louis Park, Minnesota, United States, 55416
Contact: Wanda Konerza       wanda.konerza@parknicollet.com   
Principal Investigator: Richard Bergenstal, MD         
United States, North Carolina
Physicians East Not yet recruiting
Greenville, North Carolina, United States, 27834
Contact: Elizabeth Ashley Kirk       akirk@physicianseast.com   
Principal Investigator: Mark Warren, MD         
United States, Oregon
OHSU Not yet recruiting
Portland, Oregon, United States, 97239
Contact: Deborah Brandigan         
Contact       branigad@ohsu.edu   
Principal Investigator: Joseph El Yousseff, MD         
United States, Texas
Texas Diabetes Not yet recruiting
Austin, Texas, United States, 78749
Contact: Lauren Shelton       lshelton@texasdiabetes.com   
Principal Investigator: Lindsay Harrison, MD         
United States, Washington
Rainier Research Not yet recruiting
Renton, Washington, United States, 98057
Contact: Teresa Mori       tmori@rainier-research.com   
Principal Investigator: Ronald Brazg, MD         
Sponsors and Collaborators
Medtronic Diabetes
Eli Lilly and Company
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Responsible Party: Medtronic Diabetes
ClinicalTrials.gov Identifier: NCT05325294    
Other Study ID Numbers: CIP335
First Posted: April 13, 2022    Key Record Dates
Last Update Posted: May 11, 2022
Last Verified: May 2022

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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, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases