Evaluation of the Advanced Hybrid Closed Loop (AHCL) System in Type 1 Adults and Pediatrics Utilizing Lyumjev®

NCT05325294 | Completed Results DMC FDA Device

• 1 other identifier: CIP335
• Study Type: interventional
• Target: 244
• Locations: 1 country
• Sites: 19

Brief Summary

This US study will evaluate the safety and effectiveness of utilizing insulin Lyumjev® lispro-aabc in the MiniMed™ 780G System in Type 1 adult and pediatric subjects in a home setting to support product and system labeling.

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (2)

• Primary Safety Endpoint - Change in HbA1c

  The overall mean change in HbA1c from baseline to end of 3-month study period. Non-inferiority test.

  3 months

• Primary Effectiveness Endpoint - Percent of Time in Range (TIR 70-180 mg/dL)

  The mean % of time in range (TIR 70-180 mg/dL). Non-inferiority test.

  Last 6-7 weeks of 3 month study period

Secondary Outcomes (2)

• Secondary Effectiveness Endpoint 1 - Percent of Time in Hypoglycemia (< 54 mg/dL)

  Last 6-7 weeks of 3 month study period

• Secondary Effectiveness Endpoint 2 - Percent of Time in Range (TIR 70-180 mg/dL)

  Last 6-7 weeks of 3 month study period

Study Arms (1)

MiniMed 780G System Utilizing Insulin Lyumjev®

EXPERIMENTAL

Subjects with insulin-requiring type 1 diabetes age 7-80 using the MiniMed 780G system with Insulin Lyumjev® for a period of three months.

Device: MiniMed 780G System

Interventions

MiniMed 780G System DEVICE

MiniMed™ 780G Insulin Pump, Guardian™ 4 Glucose Sensor, and Guardian 4 Transmitter; used with Insulin Lyumjev® insulin lispro-aabc

MiniMed 780G System Utilizing Insulin Lyumjev®

Eligibility Criteria

• Age: 7 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 7-80 years at time of screening.
• Has a clinical diagnosis of type 1 diabetes:
• 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.
• 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.
• Does not require a legally authorized representative to consent on their behalf due to mental or intellectual disability.
• Subject or parent/caregiver is literate and able to read the language offered in the pump or pump materials.
• Subject and/or legally authorized representative is willing to provide informed consent for participation.
• Is willing to perform fingerstick blood glucose measurements as needed.
• Is willing to wear the system continuously throughout the study.
• Must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units and a maximum total daily dose of 250 units or less.
• 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 National Glycohemoglobin Standardization Program (NGSP) certified Central Laboratory. HbA1c testing must follow NGSP standards.
• Has thyroid-stimulating hormone (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.
• Uses pump therapy for greater than 6 months (with or without CGM experience) prior to screening
• Is willing to upload data from the study pump, must have Internet access, and a computer system, or compatible smartphone that meets the requirements for uploading the study pump.

You may not qualify if:

• Has hypersensitivity to insulin lispro or one of the excipients in Lyumjev®
• Has a history of 2 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
• Has been hospitalized or has visited the ER in the 6 months prior to screening resulting in a primary diagnosis of uncontrolled diabetes.
• Has had DKA in the last 6 months prior to screening visit.
• Will not tolerate tape adhesive in the area of sensor placement as assessed by a qualified individual.
• Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection).
• Is female of child-bearing potential and result of pregnancy test is positive at screening.
• Is sexually active female of child-bearing potential and is not using a form of contraception deemed reliable by the investigator.
• Is female and plans to become pregnant during the course of the study
• Is being treated for hyperthyroidism at time of screening.
• Has diagnosis of adrenal insufficiency.
• Has taken any oral, injectable, or intravenous (IV) glucocorticoids within 8 weeks from time of screening visit, or plans to take any oral, injectable, or IV glucocorticoid during the course of the study.

Sponsors & Collaborators

• Medtronic Diabetes: lead
• Eli Lilly and Company: collaborator

Study Sites (19)

Stanford University

Palo Alto, California, 94304, United States

Location

Rady Children's Hospital San Diego

San Diego, California, 92123, United States

Location

Barbara Davis Center for Childhood Diabetes

Aurora, Colorado, 80045, United States

Location

Barbara Davis Center

Aurora, Colorado, 80045, United States

Location

Yale University

New Haven, Connecticut, 06511, United States

Location

East Coast Institute for Research (Memorial Hospital)

Jacksonville, Florida, 32204, United States

Location

University of South Florida Diabetes Center

Tampa, Florida, 33612, United States

Location

Atlanta Diabetes

Atlanta, Georgia, 30318, United States

Location

East Coast Institute for Research - Macon

Macon, Georgia, 31210, United States

Location

Endocrine Research Solutions

Roswell, Georgia, 30076, United States

Location

Rocky Mountain

Idaho Falls, Idaho, 83404, United States

Location

Barry J Reiner MD LLC

Baltimore, Maryland, 21229, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

International Diabetes Center

Saint Louis Park, Minnesota, 55416, United States

Location

The Docs LLC

Las Vegas, Nevada, 89113, United States

Location

Physicians East

Greenville, North Carolina, 27834, United States

Location

Texas Diabetes

Austin, Texas, 78749, United States

Location

Diabetes and Glandular Disease Clinic, P.A

San Antonio, Texas, 78229, United States

Location

Rainier Research

Renton, Washington, 98057, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Results Point of Contact

• Title: Fang Niu, Sr Statistician
• Organization: Medtronic Diabetes

fang.niu@medtronic.com

8185763319

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: April 5, 2022
• First Posted: April 13, 2022
• Study Start: May 5, 2022
• Primary Completion: January 3, 2024
• Study Completion: January 3, 2024
• Last Updated: January 15, 2025
• Results First Posted: January 15, 2025

Record last verified: 2024-12

Locations

US (19)