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

NCT ID: NCT03959423

Last Updated: 2025-01-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 288 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-07-24
• Study Completion Date: 2023-10-27

Brief Summary

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

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).

Conditions

Type 1 Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Subjects 7-75 years of age

Subjects who have been diagnosed with type 1 diabetes

Group Type: EXPERIMENTAL

AHCL insulin pump system

Intervention Type: DEVICE

670G 4.0 system with GS3; 780G system with G4S (continued access phase);

Interventions

AHCL insulin pump system

670G 4.0 system with GS3; 780G system with G4S (continued access phase);

Intervention Type: DEVICE

Eligibility Criteria

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

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.

• Minimum Eligible Age: 7 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic Diabetes

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Arkansas Diabetes and Endocrinology Center

Little Rock, Arkansas, United States

Scripps Whittier Diabetes Institute

La Jolla, California, United States

SoCal Diabetes

Torrance, California, United States

Diablo Clinical Research

Walnut Creek, California, United States

Barbara Davis Center - Adults

Aurora, Colorado, United States

Barbara Davis Center - Pediatric

Aurora, Colorado, United States

Yale Diabetes Research Program

New Haven, Connecticut, United States

University of South Florida

Tampa, Florida, United States

Atlanta Diabetes Associates

Atlanta, Georgia, United States

Southeastern Endocrine

Roswell, Georgia, United States

Rocky Mountain Diabetes Center

Idaho Falls, Idaho, United States

International Diabetes Center

Minneapolis, Minnesota, United States

AM Diabetes & Endocrinology Center

Bartlett, Tennessee, United States

Texas Endocrinology

Austin, Texas, United States

Diabetes and Glandular Disease Clinic

San Antonio, Texas, United States

Rainier Clinical Research

Renton, Washington, United States

Seattle Children's Hospital and Medical Center

Seattle, Washington, United States

Countries

United States

References

Pihoker C, Shulman DI, Forlenza GP, Kaiserman KB, Sherr JL, Thrasher JR, Buckingham BA, Kipnes MS, Bode BW, Carlson AL, Lee SW, Latif K, Liljenquist DR, Slover RH, Dai Z, Niu F, Shin J, Jonkers RAM, Roy A, Grosman B, Vella M, Cordero TL, McVean J, Rhinehart AS, Vigersky RA; MiniMed AHCL Study Group. Safety and Glycemic Outcomes During the MiniMedTM Advanced Hybrid Closed-Loop System Pivotal Trial in Children and Adolescents with Type 1 Diabetes. Diabetes Technol Ther. 2023 Nov;25(11):755-764. doi: 10.1089/dia.2023.0255. Epub 2023 Oct 25.

Reference Type: DERIVED

PMID: 37782145 (View on PubMed)

Cordero TL, Dai Z, Arrieta A, Niu F, Vella M, Shin J, Rhinehart AS, McVean J, Lee SW, Slover RH, Forlenza GP, Shulman DI, Pop-Busui R, Thrasher JR, Kipnes MS, Christiansen MP, Buckingham BA, Pihoker C, Sherr JL, Kaiserman KB, Vigersky RA. Glycemic Outcomes During Early Use of the MiniMed 780G Advanced Hybrid Closed-Loop System with Guardian 4 Sensor. Diabetes Technol Ther. 2023 Sep;25(9):652-658. doi: 10.1089/dia.2023.0123. Epub 2023 Jun 16.

Reference Type: DERIVED

PMID: 37252734 (View on PubMed)

Carlson AL, Sherr JL, Shulman DI, Garg SK, Pop-Busui R, Bode BW, Lilenquist DR, Brazg RL, Kaiserman KB, Kipnes MS, Thrasher JR, Reed JHC, Slover RH, Philis-Tsimikas A, Christiansen M, Grosman B, Roy A, Vella M, Jonkers RAM, Chen X, Shin J, Cordero TL, Lee SW, Rhinehart AS, Vigersky RA. Safety and Glycemic Outcomes During the MiniMed Advanced Hybrid Closed-Loop System Pivotal Trial in Adolescents and Adults with Type 1 Diabetes. Diabetes Technol Ther. 2022 Mar;24(3):178-189. doi: 10.1089/dia.2021.0319. Epub 2021 Nov 16.

Reference Type: DERIVED

PMID: 34694909 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

CIP321

Identifier Type: -

Identifier Source: org_study_id