Medtronic study with Personalized Closed Loop

Overview

About this study

The purpose of this study is to collect device data to assist in the development of a Personalized Closed Loop (PCL) system.

 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Subject is age 2-80 years at time of Visit 1.
  • Subject has a clinical diagnosis of type 1 diabetes.
    • Subjects 7 years of age and older: Diagnosed at least 1 year prior to Visit 1;
    • Subjects 2-6 years of age: Diagnosed at least 3 months prior to Visit 1.

Study-specific Inclusion Criteria:

  • Subject must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units.
  • If subject has a history of hypothyroidism, must have at least 1 documented normal thyroid-stimulating hormone (TSH) on historical labs within 12 months of Visit 1.
  • Subjects and their parent(s)/guardian(s) must have Internet access, a computer system that meets the requirements for uploading the study pump and Smartphone that meets study requirements.
  • Subject must have a companion or caregiver available at night for the duration of the study period who resides (or will live) in in the same building (or home). This requirement may be verified by subject report at screening visit.
  • If subject has celiac disease, it has been adequately treated as determined by the investigator.
  • Subjects and their parent(s)/guardian(s) are willing to take one of the following insulins and can financially support the use of either of the 2 insulin preparations throughout the course of the study (i.e. co-payments for insulin with insurance or able to pay full amount):
    • Humalog™* (insulin lispro injection);
    • NovoLog™* (insulin aspart).

Exclusion Criteria:

  • Subject has a history of 1 or more episodes of severe hypoglycemia, which resulted in any the following during the last 1 year prior to Visit 1:
    • Medical assistance (i.e., Paramedics, Emergency Room (ER) or Hospitalization);
    • Coma;
    • Seizures.
  • Subject is unable to tolerate tape adhesive in the area of sensor placement.
  • Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
  • Women of child-bearing potential who have a positive pregnancy test at Visit 1 or plan to become pregnant during the course of the study.
  • Females who are sexually active and able to conceive will be excluded if they are not using an effective method of contraception and do not agree to continue using an effective method of contraception for the duration of the study as determined by investigator.
  • Subject has a cardiovascular condition which the Study Investigator determines should exclude the subject; e.g., ventricular rhythm disturbance, hypertrophic cardiomyopathy, recent myocardial infarction in the last year prior to Visit 1.
  • Subject is being treated for hyperthyroidism at time of Visit 1.
  • Subject has a diagnosis of adrenal insufficiency.
  • Subject has had Diabetic Ketoacidosis (DKA) within 1 year prior to Visit 1.
  • Subject has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of visit 1, or plans to take any oral, injectable, or IV glucocorticoids during the course of the study.
  • Subject is actively participating in an investigational study (e.g., drug or device) wherein he/she has received treatment from an investigational study (drug or device) in the last 2 weeks prior to Visit 1. Please note participation in observational study is acceptable.
  • Subject has been hospitalized or has visited the ER in the 6 months prior to Visit 1 resulting in a primary diagnosis of uncontrolled diabetes.
  • Subject is currently abusing illicit drugs.
  • Subject is currently abusing alcohol.
  • Subject is using pramlintide (Symlin), DPP-4 inhibitor, liraglutide (Victoza or other GLP-1 agonists), metformin, canagliflozin (Invokana or other SGLT2 inhibitors) at time of Visit 1.
  • Subject 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.
  • Subject has elective surgery planned that requires general anesthesia during the course of the study.
  • Subject diagnosed with current eating disorder such as anorexia or bulimia.
  • Subject has been diagnosed with chronic kidney disease that results in chronic anemia.
  • Subject is on dialysis.
  • Subject has serum creatinine of > 2 mg/dL, as confirmed through historical labs within 1 year prior to Visit 1.
  • Subject is a member the research staff involved with the study.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Yogish Kudva, M.B.B.S.

Closed for enrollment

Contact information:

Shelly McCrady-Spitzer M.S.

(507) 255-5916

McCradySpitzer.Shelly@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20491946

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