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

NCT03959423 | Completed Results DMC FDA Device

• 1 other identifier: CIP321
• Study Type: interventional
• Target: 288
• Locations: 1 country
• Sites: 17

Brief Summary

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

Conditions

Type 1 Diabetes Mellitus

Outcome Measures

Primary Outcomes (2)

• Change in HbA1c

  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

  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 Outcomes (3)

• Number of Severe Hypoglycemic Event

  3-month Study Period

• Number of Diabetic Ketoacidosis (DKA) Event

  3-month Study Period

• Change in Percent of Time in Hypoglycemic Range (<70 mg/dL)

  Baseline to End of 3-Month Study Period

Study Arms (1)

Subjects 7-75 years of age

EXPERIMENTAL

Subjects who have been diagnosed with type 1 diabetes

Device: AHCL insulin pump system

Interventions

AHCL insulin pump system DEVICE

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

Subjects 7-75 years of age

Eligibility Criteria

• Age: 7 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject is age 7-75 years at time of Screening
• 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
• Subject is willing to perform ≥ 4 finger stick blood glucose measurements daily
• Subject is willing to perform required sensor calibrations
• Subject is willing to wear the system continuously throughout the study
• Subject must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units
• 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.
• 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.
• Pump therapy for greater than 6 months prior to screening (with or without CGM experience)
• 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.
• 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
• If subject has celiac disease, it has been adequately treated as determined by the investigator
• 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)

You may not qualify if:

• 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:
• Medical assistance (i.e. Paramedics, Emergency Room (ER) or Hospitalization)
• Coma
• Seizures
• Subject has been hospitalized or has visited the ER in the 6 months prior to Screening resulting in a primary diagnosis of uncontrolled diabetes
• Subject has had Diabetic Ketoacidosis (DKA) in the 6 months prior to Screening.
• Subject has Hypoglycemia Unawareness, as measured by the Gold questionnaire (Gold, MacLeod et al. 1994) at Screening
• 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 Screening 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 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
• Subject is being treated for hyperthyroidism at time of Screening
• Subject has a diagnosis of adrenal insufficiency
• 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

Sponsors & Collaborators

• Medtronic Diabetes: lead

Study Sites (17)

Arkansas Diabetes and Endocrinology Center

Little Rock, Arkansas, 72211, United States

Location

Scripps Whittier Diabetes Institute

La Jolla, California, 92037, United States

Location

SoCal Diabetes

Torrance, California, 90505, United States

Location

Diablo Clinical Research

Walnut Creek, California, 94598, United States

Location

Barbara Davis Center - Adults

Aurora, Colorado, 80045, United States

Location

Barbara Davis Center - Pediatric

Aurora, Colorado, 80045, United States

Location

Yale Diabetes Research Program

New Haven, Connecticut, 06511, United States

Location

University of South Florida

Tampa, Florida, 33613, United States

Location

Atlanta Diabetes Associates

Atlanta, Georgia, 30318, United States

Location

Southeastern Endocrine

Roswell, Georgia, 30076, United States

Location

Rocky Mountain Diabetes Center

Idaho Falls, Idaho, 83404, United States

Location

International Diabetes Center

Minneapolis, Minnesota, 55416, United States

Location

AM Diabetes & Endocrinology Center

Bartlett, Tennessee, 38133, United States

Location

Texas Endocrinology

Austin, Texas, 78681, United States

Location

Diabetes and Glandular Disease Clinic

San Antonio, Texas, 78229, United States

Location

Rainier Clinical Research

Renton, Washington, 98057, United States

Location

Seattle Children's Hospital and Medical Center

Seattle, Washington, 98105, United States

Location

Related Publications (3)

• 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.

  PMID: 37782145 DERIVED

• 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.

  PMID: 37252734 DERIVED

• 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.

  PMID: 34694909 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: DZ Dai, Sr Statistician
• Organization: Medtronic Diabetes

dz.dai@medtronic.com

8185764034

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 20, 2019
• First Posted: May 22, 2019
• Study Start: July 24, 2019
• Primary Completion: March 17, 2021
• Study Completion: October 27, 2023
• Last Updated: January 14, 2025
• Results First Posted: April 8, 2022

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (17)