Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System

December 15, 2023 updated by: Medtronic Diabetes

Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adult and Pediatric Subjects

This study is a Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adult and Pediatric Subjects.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

The purpose of this study is to evaluate the safety of the Advanced Hybrid Closed Loop system (AHCL) in type 1 diabetes adult and pediatric subjects in a home setting. The main objective in conducting this research is to collect data from patients who use the AHCL system at home, at work, at school and everywhere else. Subjects will use 670G 4.0 system with Guardian Sensor 3 (GS3) during study period, and will be allowed to participate in continued access phase, and use 670G 4.0 system with GS3 and 780G system with Guardian 4 Sensor (G4S).

Study Type

Interventional

Enrollment (Actual)

288

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Arkansas Diabetes and Endocrinology Center
    • California
      • La Jolla, California, United States, 92037
        • Scripps Whittier Diabetes Institute
      • Torrance, California, United States, 90505
        • SoCal Diabetes
      • Walnut Creek, California, United States, 94598
        • Diablo Clinical Research
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Barbara Davis Center - Adults
      • Aurora, Colorado, United States, 80045
        • Barbara Davis Center - Pediatric
    • Connecticut
      • New Haven, Connecticut, United States, 06511
        • Yale Diabetes Research Program
    • Florida
      • Tampa, Florida, United States, 33613
        • University of South Florida
    • Georgia
      • Atlanta, Georgia, United States, 30318
        • Atlanta Diabetes Associates
      • Roswell, Georgia, United States, 30076
        • Southeastern Endocrine
    • Idaho
      • Idaho Falls, Idaho, United States, 83404
        • Rocky Mountain Diabetes Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55416
        • International Diabetes Center
    • Tennessee
      • Bartlett, Tennessee, United States, 38133
        • AM Diabetes & Endocrinology Center
    • Texas
      • Austin, Texas, United States, 78681
        • Texas Endocrinology
      • San Antonio, Texas, United States, 78229
        • Diabetes and Glandular Disease Clinic
    • Washington
      • Renton, Washington, United States, 98057
        • Rainier Clinical Research
      • Seattle, Washington, United States, 98105
        • Seattle Children's Hospital and Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

7 years to 75 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subject is age 7-75 years at time of Screening
  2. Subjects 14-75 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
  3. Subjects 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 Study-specific inclusion criteria
  4. Subject is willing to perform ≥ 4 finger stick blood glucose measurements daily
  5. Subject is willing to perform required sensor calibrations
  6. Subject is willing to wear the system continuously throughout the study
  7. Subject must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units
  8. Subject 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 NGSP certified Central Laboratory. HbA1c testing must follow National Glycohemoglobin Standardization Program (NGSP) standards.
  9. Subject has 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. Pump therapy for greater than 6 months prior to screening (with or without CGM experience)
  11. 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). A companion or caregiver should also be available during exercise challenges in the same building, home or location (if not at home). This requirement may be verified by subject report at screening visit.
  12. Subject willing to upload data from the study pump, must have Internet access and a computer system that meets the requirements for uploading the study pump
  13. If subject has celiac disease, it has been adequately treated as determined by the investigator
  14. Subject is 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)
  15. Subjects with history of cardiovascular event 1 year or more from the time of screening must have an EKG within 6 months prior to screening or during screening. If subject has an abnormal EKG, participation is allowed if there is clearance from a cardiologist
  16. Subjects with the 3 or more cardiovascular risk factors listed below must have an EKG within 6 months prior to screening or during screening. If subject has an abnormal EKG, participation is allowed if there is clearance from a cardiologist

    a. Cardiovascular risk factors include:

    • 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
  17. Subjects with history of cardiovascular event 1 year or more from the time of screening must have a stress test within 6 months prior to screening or during run in period. If subject fails stress test, participation is allowed if there is clearance from a cardiologist

Exclusion Criteria:

  1. Subject has a history of 1 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. Subject has been hospitalized or has visited the ER in the 6 months prior to Screening resulting in a primary diagnosis of uncontrolled diabetes
  3. Subject has had Diabetic Ketoacidosis (DKA) in the 6 months prior to Screening.
  4. Subject has Hypoglycemia Unawareness, as measured by the Gold questionnaire (Gold, MacLeod et al. 1994) at Screening
  5. Subject is unable to tolerate tape adhesive in the area of sensor placement
  6. Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection)
  7. Women of child-bearing potential who have a positive pregnancy test at Screening or plan to become pregnant during the course of the study
  8. 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.
  9. Subject 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, ventricular rhythm disturbances or thromboembolic disease
  10. Subject is being treated for hyperthyroidism at time of Screening
  11. Subject has a diagnosis of adrenal insufficiency
  12. Subject has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of Screening, or plans to take any oral, injectable, or IV glucocorticoids during the course of the study
  13. Subject 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. Subject is currently abusing illicit drugs
  15. Subject is currently abusing marijuana
  16. Subject is currently abusing prescription drugs
  17. Subject is currently abusing alcohol
  18. 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 Screening
  19. 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
  20. Subject has elective surgery planned that requires general anesthesia during the course of the study
  21. Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of Screening
  22. Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation
  23. Subject diagnosed with current eating disorder such as anorexia or bulimia
  24. Subject has been diagnosed with chronic kidney disease that results in chronic anemia
  25. Subject has a hematocrit that is below the normal reference range of lab used.
  26. Subject is on dialysis
  27. Subject has serum creatinine of >2 mg/dL.
  28. Research staff involved with the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Subjects 7-75 years of age
Subjects who have been diagnosed with type 1 diabetes
670G 4.0 system with GS3; 780G system with G4S (continued access phase);

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in HbA1c
Time Frame: Baseline to End of 3-Month Study Period
The overall mean difference of the change in HbA1c from baseline to end of 3-month Study Period.
Baseline to End of 3-Month Study Period
Change in Percentage of Euglycemia
Time Frame: Baseline to End of 3-Month Study Period
The overall mean change in % of time in euglycemia (70-180 mg/dL) from baseline to end of 3-month Study Period will be estimated.
Baseline to End of 3-Month Study Period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Severe Hypoglycemic Event
Time Frame: 3-month Study Period
Number of severe hypoglycemic events occurred during 3-month Study Period
3-month Study Period
Number of Diabetic Ketoacidosis (DKA) Event
Time Frame: 3-month Study Period
Number of Diabetic Ketoacidosis (DKA) event occurred during 3-month Study Period
3-month Study Period
Change in Percent of Time in Hypoglycemic Range (<70 mg/dL)
Time Frame: Baseline to End of 3-Month Study Period
The overall mean change in % of time in hypoglycemic range (<70 mg/dL) from baseline to end of 3-month Study Period will be estimated.
Baseline to End of 3-Month Study Period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2019

Primary Completion (Actual)

March 17, 2021

Study Completion (Actual)

October 27, 2023

Study Registration Dates

First Submitted

May 20, 2019

First Submitted That Met QC Criteria

May 20, 2019

First Posted (Actual)

May 22, 2019

Study Record Updates

Last Update Posted (Actual)

December 19, 2023

Last Update Submitted That Met QC Criteria

December 15, 2023

Last Verified

December 1, 2023

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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