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Safety Evaluation of the Advanced Hybrid Closed Loop (AHCL) System | Clinical Trials | Clareo Health

COMPLETEDNA

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

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

NCT03959423•Medtronic Diabetes

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).

Eligibility

Age

7 - 75 years

Sex

ALL

Healthy Volunteers

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.
+15 more criteria

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
+21 more criteria

Locations (17)

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

Key Dates

Start Date

July 24, 2019

Primary Completion Date

March 17, 2021

Completion Date

October 27, 2023

Last Updated

January 14, 2025

Enrollment

288

ACTUAL participants

Conditions

Type 1 Diabetes Mellitus

Interventions

AHCL insulin pump system

DEVICE

Feasibility of a Tailored Online Self-compassion Intervention

NCT07051005

Type 1 Diabetes MellitusType 2 Diabetes Mellitus (T2DM)

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RECRUITINGNA

Implementing the Spotlight AQ Platform in Adolescent/ Young Adult (16-25 Years Old) Type 1 Diabetics (T1D)

NCT06390371

Type 1 Diabetes Mellitus

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RECRUITING

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: January 14, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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