In-Home Study With MiniMed™ 780G Pump Automated Control in Type 2-Evaluation of the AHCL System in Adults With Insulin-requiring Type 2 Diabetes

NCT05238142 | Completed Results DMC FDA Device

• 1 other identifier: CIP341
• Study Type: interventional
• Target: 574
• Locations: 1 country
• Sites: 31

Brief Summary

The objective of the study is to assess the safety and effectiveness of MiniMed™ 780G system in adult subjects with insulin-requiring type 2 diabetes in a home setting. The combined run-in period and study period will be approximately 135 days long.

Conditions

Type 2 Diabetes Treated With Insulin

Outcome Measures

Primary Outcomes (5)

• Primary Safety Endpoint - Change in HbA1c Phase 1

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

  Baseline and end of 3-month study period

• Primary Effectiveness Endpoint - Percent of Time in Range (TIR 70-180 mg/dL) Phase 1

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

  Last 6 weeks of 3 month study period

• Primary Safety Endpoint - Change in HbA1c Phase 2 Transition

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

  Baseline and end of 3-month study period

• Primary Safety Endpoint - Change in HbA1c Phase 2 Naive

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

  Baseline and end of 3-month study period

• Primary Effectiveness Endpoint - Percent of Time in Range (TIR 70-180 mg/dL) Phase 2 Transition + Naive

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

  Last 6 weeks of 3 month study period

Secondary Outcomes (2)

• Secondary Effectiveness Endpoint - Percent of Time in Range (TIR 70-180 mg/dL) Phase 1

  Last 6 weeks of 3 month study period

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

  Last 6 weeks of 3 month study period

Study Arms (1)

MiniMed 780G System

EXPERIMENTAL

Adult participants with insulin-requiring type 2 diabetes age 18-80 using the MiniMed 780G system for a combined run-in period and study period will be approximately 135 days long.

Device: MiniMed™ 780G Insulin Pump system

Interventions

MiniMed™ 780G Insulin Pump system DEVICE

MiniMed 780G insulin pump with Guardian 4 sensor (phase 1) MiniMed™ 780G BLE 2.0 insulin pump used in combination with Disposable Sensor 5 (phase 2)

MiniMed 780G System

Eligibility Criteria

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

You may qualify if:

• Is age 18 - 80 years at time of screening.
• Has a clinical diagnosis of type 2 diabetes for 2 years or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis.
• Is on MDI regimen (basal/bolus regimen with long-acting insulin and rapid-acting analogs), defined as greater than or equal to 2 injections per day for at least 3 months prior signing the informed consent, or CSII pump therapy with or without CGM. The investigator will use their discretion to verify that insulin requirements have been stable for the last 3 months prior to screening.
• Is able to comply with technology, according to Investigator's judgment
• Does not require a legally authorized representative to consent on their behalf due to mental or intellectual disability.
• Is willing to perform fingerstick blood glucose measurements as needed.
• Is willing to wear the system continuously throughout the study.
• Has a Glycosylated hemoglobin (HbA1c) of 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.
• 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.
• Is willing to take one of the following insulins and can financially support the use of insulin preparations as required by the study:
• Humalog (insulin lispro injection)
• NovoLog/NovoRapid (insulin aspart injection)
• Admelog (insulin lispro injection)

You may not qualify if:

• 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 diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar syndrome (HHS) 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) at time of screening.
• Has (Total Daily Dose) of less than 8 units or greater than 250 units at time of screening.
• Has positive GAD (Glutamic Acid Decarboxylase) Antibody test
• 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 at time of screening.

Sponsors & Collaborators

• Medtronic MiniMed, Inc.: lead

Study Sites (31)

Medical Investigations

Little Rock, Arkansas, 72211, United States

Location

Headlands Research California LLC

Escondido, California, 92025, United States

Location

Loma Linda University Medical Center

Loma Linda, California, 92354, United States

Location

Hoag Hospital Newport Beach

Newport Beach, California, 92663, United States

Location

Mills-Peninsula Medical Center: Diabetes Research Institute

San Mateo, California, 94401, United States

Location

Sansum Diabetes Research Institute

Santa Barbara, California, 93105, United States

Location

East Coast Institute for Research

Jacksonville, Florida, 32204, United States

Location

USF Diabetes Center

Tampa, Florida, 33612, United States

Location

Atlanta Diabetes Associates

Atlanta, Georgia, 30318, United States

Location

East Coast Institute for Research

Canton, Georgia, 30114, United States

Location

East Coast Institute for Research

Macon, Georgia, 31210, United States

Location

Endocrine Research Solutions

Roswell, Georgia, 30076, United States

Location

Javara

Thomasville, Georgia, 31792, United States

Location

NorthShore University Health System

Skokie, Illinois, 60077, United States

Location

Iowa Diabetes Research

West Des Moines, Iowa, 50265, United States

Location

MedStar Good Samaritan Hospital

Baltimore, Maryland, 21239, United States

Location

Endocrine & Metabolic Consultants

Rockville, Maryland, 20852, United States

Location

Park Nicollet International Diabetes Center

Saint Louis Park, Minnesota, 55416, United States

Location

Bryan Health

Lincoln, Nebraska, 68506, United States

Location

Atlantic Health System

Morristown, New Jersey, 07962, United States

Location

NYC Research Inc

Long Island City, New York, 11106, United States

Location

Northwell Health Physician Partners Endocrinology

New York, New York, 10022, United States

Location

Physicians East

Greenville, North Carolina, 27834, United States

Location

Texas Diabetes and Endocrinology

Austin, Texas, 78731, United States

Location

Javara

Conroe, Texas, 77384, United States

Location

Velocity Clinical Research

Dallas, Texas, 75230, United States

Location

Prime Revival Research Institute

Flower Mound, Texas, 75028, United States

Location

Houston Methodist Research Institute

Houston, Texas, 77030, United States

Location

Tekton Research

McKinney, Texas, 75069, United States

Location

Virginia Endocrinology Research

Chesapeake, Virginia, 23321, United States

Location

Rainier Clinical Research Center

Renton, Washington, 98057, United States

Location

Results Point of Contact

• Title: Thomas Troub, Sr Clinical Research Manager
• Organization: Medtronic Diabetes

thomas.troub@medtronic.com

1-800-646-4633

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• 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: February 3, 2022
• First Posted: February 14, 2022
• Study Start: February 25, 2022
• Primary Completion: January 11, 2025
• Study Completion: January 11, 2025
• Last Updated: April 16, 2026
• Results First Posted: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (31)