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Type 2 Diabetes Treated With InsulinNCT05238142

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

A study testing MiniMed™ 780G Insulin Pump system in people with Type 2 Diabetes Treated With Insulin, run by Medtronic MiniMed, Inc. at 31 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Type 2 Diabetes Treated With Insulin
What is being tested?
MiniMed™ 780G Insulin Pump system
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
574 participants
Where
31 sitesUnited States
Study dates
25 Feb 2022to 11 Jan 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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)

Who cannot join

  • 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.
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  • 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.
  • 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 glucocorticoids during the course of the study.
  • Note: Intra-articular injections to treat pain (e.g., joint pain, bursitis, etc.) are permitted
  • Is using hydroxyurea at time of screening or plans to use it during the study.
  • 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 prior to screening.(Note: Did not apply to subjects who transitioned from Phase 1 to Phase 2)
  • Is currently abusing illicit drugs.
  • Is currently abusing marijuana.
  • Is currently abusing prescription drugs.
  • Is currently abusing alcohol.
  • 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.
  • Has elective surgery planned that requires general anesthesia during the course of the study.
  • Has sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening.
  • Plans to receive red blood cell transfusion or erythropoietin over the course of study participation.
  • Is diagnosed with current eating disorder such as anorexia or bulimia.
  • Has been diagnosed with chronic kidney disease greater than CKD2 that results in chronic anemia.
  • Has a hematocrit that is below the normal reference range of lab used.
  • Is on dialysis.
  • Has serum creatinine of >2 mg/dL.
  • Has celiac disease that is not adequately treated as determined by the investigator.
  • 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, or ventricular rhythm disturbances.
  • Has had any of the following cardiovascular events 1 year or more prior to screening: Myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack, cerebrovascular accident, angina, congestive heart failure, or ventricular rhythm disturbances. Subject may be enrolled if clearance from a board-certified cardiologist is provided prior to or at Screening.
  • Is a member of the research staff involved with the study.
  • Has used a MiniMed 780G pump prior to screening (Note: In Phase 2, this applies to new subjects only).

Trial locations and contacts

31 sites in 1 country.

31 sites in 1 country

United States31 sites
  • Atlanta Diabetes Associates

    Atlanta, Georgia, 30318

  • Texas Diabetes and Endocrinology

    Austin, Texas, 78731

  • MedStar Good Samaritan Hospital

    Baltimore, Maryland, 21239

  • East Coast Institute for Research

    Canton, Georgia, 30114

  • Virginia Endocrinology Research

    Chesapeake, Virginia, 23321

  • Javara

    Conroe, Texas, 77384

  • Velocity Clinical Research

    Dallas, Texas, 75230

  • Headlands Research California LLC

    Escondido, California, 92025

  • Prime Revival Research Institute

    Flower Mound, Texas, 75028

  • Physicians East

    Greenville, North Carolina, 27834

  • Houston Methodist Research Institute

    Houston, Texas, 77030

  • East Coast Institute for Research

    Jacksonville, Florida, 32204

  • Bryan Health

    Lincoln, Nebraska, 68506

  • Medical Investigations

    Little Rock, Arkansas, 72211

  • Loma Linda University Medical Center

    Loma Linda, California, 92354

  • NYC Research Inc

    Long Island City, New York, 11106

  • East Coast Institute for Research

    Macon, Georgia, 31210

  • Tekton Research

    McKinney, Texas, 75069

  • Atlantic Health System

    Morristown, New Jersey, 07962

  • Northwell Health Physician Partners Endocrinology

    New York, New York, 10022

  • Hoag Hospital Newport Beach

    Newport Beach, California, 92663

  • Rainier Clinical Research Center

    Renton, Washington, 98057

  • Endocrine & Metabolic Consultants

    Rockville, Maryland, 20852

  • Endocrine Research Solutions

    Roswell, Georgia, 30076

  • Park Nicollet International Diabetes Center

    Saint Louis Park, Minnesota, 55416

  • Mills-Peninsula Medical Center: Diabetes Research Institute

    San Mateo, California, 94401

  • Sansum Diabetes Research Institute

    Santa Barbara, California, 93105

  • NorthShore University Health System

    Skokie, Illinois, 60077

  • USF Diabetes Center

    Tampa, Florida, 33612

  • Javara

    Thomasville, Georgia, 31792

  • Iowa Diabetes Research

    West Des Moines, Iowa, 50265

Other trials in United States

About this study

Official title: 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

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.

Read the detailed description

Phase 1 of the study, will utilize the MiniMed™ 780G Insulin pump with Guardian 4 sensor for the run-in period, study period, and optional continued access. Phase 2 of the study will utilize the MiniMed™ 780G BLE2.0 insulin pump with the Disposable Sensor 5 for the run-in period and study period which will be approximately 135 days long. A total of up to 575 subjects with at least 300 subjects entering the study period of Phase 2, with insulin-requiring diabetes age 18-80 will be enrolled at up to 40 investigational centers across the United States.

Being tested
MiniMed™ 780G Insulin Pump system

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MiniMed™ 780G Insulin Pump systemDevice

    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)

Study groups in NCT05238142
Study groupRoleWhat they receive
MiniMed 780G SystemExperimentalAdult 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.
Receives: Device: MiniMed™ 780G Insulin Pump system

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline and end of 3-month study period

  2. 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.

    Measured: Last 6 weeks of 3 month study period

  3. 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.

    Measured: Baseline and end of 3-month study period

  4. 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.

    Measured: Baseline and end of 3-month study period

  5. 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.

    Measured: Last 6 weeks of 3 month study period

Secondary outcomes (2)
  1. Secondary 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). Superiority test.

    Measured: Last 6 weeks of 3 month study period

  2. Secondary 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). Superiority test.

    Measured: Last 6 weeks of 3 month study period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Feb 2022
  2. Study start25 Feb 2022
  3. Primary completion11 Jan 2025
  4. Study completion11 Jan 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
574 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05238142
Sponsor's protocol ID
CIP341
Status last verified
Apr 2026
First submitted
3 Feb 2022
Last updated
16 Apr 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Bhargava A, Bergenstal RM, Warren ML, Thrasher JR, Dempsey MA, Bode BW, LaRocque J, Carlson AL, Keiter A, Ma H, Shin JJ, McVean JJ, Cordero TL, Rhinehart AS, Vigersky RA; IMPACT2D Study Group. Safety and Effectiveness of MiniMedTM 780G Advanced Hybrid Closed-Loop Insulin Intensification in Adults with Insulin-Requiring Type 2 Diabetes. Diabetes Technol Ther. 2025 May;27(5):366-375. doi: 10.1089/dia.2024.0586. Epub 2025 Feb 6.

    PubMed 39912797

Questions about this trial

What is this clinical trial studying?

A study testing MiniMed™ 780G Insulin Pump system in people with Type 2 Diabetes Treated With Insulin, run by Medtronic MiniMed, Inc. at 31 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 37 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 31 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 16 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Primary Safety Endpoint - Change in HbA1c Phase 1 (time frame: Baseline and end of 3-month study period). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05238142, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Apr 2026.

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