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Smart insulin pump helps type 2 diabetes patients control blood sugar at home

NCT ID NCT05238142

Disease control Sponsor: Medtronic MiniMed, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested the safety and effectiveness of the MiniMed 780G automated insulin pump in 574 adults with type 2 diabetes who need insulin. Participants used the system at home for about 135 days. The goal was to see if the pump improved blood sugar control without causing safety issues.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

574 people

The number who actually took part.

Started

Feb 2022

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Is age 18 - 80 years at time of screening. 2. 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. 3. 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. 4. Is able to comply with technology, according to Investigator's judgment 5. Does not require a legally authorized representative to consent on their behalf due to mental or intellectual disability. 6. Is willing to perform fingerstick blood glucose measurements as needed. 7. Is willing to wear the system continuously throughout the study. 8. 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. 9. 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. 10. 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. 11. Is willing to take one of the following insulins and can financially support the use of insulin preparations as required by the study: 1. Humalog (insulin lispro injection) 2. NovoLog/NovoRapid (insulin aspart injection) 3. Admelog (insulin lispro injection) Exclusion Criteria: 1. Has a history of 2 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. Has been hospitalized or has visited the ER in the 6 months prior to screening resulting in a primary diagnosis of uncontrolled diabetes. 3. Has had diabetic ketoacidosis (DKA) or hyperglycemic hyperosmolar syndrome (HHS) in the last 6 months prior to screening visit. 4. Will not tolerate tape adhesive in the area of sensor placement as assessed by a qualified individual. 5. Has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection) at time of screening. 6. Has (Total Daily Dose) of less than 8 units or greater than 250 units at time of screening. 7. Has positive GAD (Glutamic Acid Decarboxylase) Antibody test 8. Is female of child-bearing potential and result of pregnancy test is positive at screening 9. Is sexually active female of child-bearing potential and is not using a form of contraception deemed reliable by the investigator. 10. Is female and plans to become pregnant during the course of the study. 11. Is being treated for hyperthyroidism at time of screening. 12. Has diagnosis of adrenal insufficiency at time of screening. 13. 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 14. Is using hydroxyurea at time of screening or plans to use it during the study. 15. 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) 16. Is currently abusing illicit drugs. 17. Is currently abusing marijuana. 18. Is currently abusing prescription drugs. 19. Is currently abusing alcohol. 20. 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. 21. Has elective surgery planned that requires general anesthesia during the course of the study. 22. Has sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening. 23. Plans to receive red blood cell transfusion or erythropoietin over the course of study participation. 24. Is diagnosed with current eating disorder such as anorexia or bulimia. 25. Has been diagnosed with chronic kidney disease greater than CKD2 that results in chronic anemia. 26. Has a hematocrit that is below the normal reference range of lab used. 27. Is on dialysis. 28. Has serum creatinine of \>2 mg/dL. 29. Has celiac disease that is not adequately treated as determined by the investigator. 30. 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. 31. 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. 32. Is a member of the research staff involved with the study. 33. Has used a MiniMed 780G pump prior to screening (Note: In Phase 2, this applies to new subjects only).

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Conditions

The condition(s) this trial relates to.

type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Type 2 diabetes treated with insulin

Contacts and locations

Locations

  • Atlanta Diabetes Associates

    Atlanta, Georgia, 30318, United States

  • Atlantic Health System

    Morristown, New Jersey, 07962, United States

  • Bryan Health

    Lincoln, Nebraska, 68506, United States

  • East Coast Institute for Research

    Jacksonville, Florida, 32204, United States

  • East Coast Institute for Research

    Canton, Georgia, 30114, United States

  • East Coast Institute for Research

    Macon, Georgia, 31210, United States

  • Endocrine & Metabolic Consultants

    Rockville, Maryland, 20852, United States

  • Endocrine Research Solutions

    Roswell, Georgia, 30076, United States

  • Headlands Research California LLC

    Escondido, California, 92025, United States

  • Hoag Hospital Newport Beach

    Newport Beach, California, 92663, United States

  • Houston Methodist Research Institute

    Houston, Texas, 77030, United States

  • Iowa Diabetes Research

    West Des Moines, Iowa, 50265, United States

  • Javara

    Thomasville, Georgia, 31792, United States

  • Javara

    Conroe, Texas, 77384, United States

  • Loma Linda University Medical Center

    Loma Linda, California, 92354, United States

  • MedStar Good Samaritan Hospital

    Baltimore, Maryland, 21239, United States

  • Medical Investigations

    Little Rock, Arkansas, 72211, United States

  • Mills-Peninsula Medical Center: Diabetes Research Institute

    San Mateo, California, 94401, United States

  • NYC Research Inc

    Long Island City, New York, 11106, United States

  • NorthShore University Health System

    Skokie, Illinois, 60077, United States

  • Northwell Health Physician Partners Endocrinology

    New York, New York, 10022, United States

  • Park Nicollet International Diabetes Center

    Saint Louis Park, Minnesota, 55416, United States

  • Physicians East

    Greenville, North Carolina, 27834, United States

  • Prime Revival Research Institute

    Flower Mound, Texas, 75028, United States

  • Rainier Clinical Research Center

    Renton, Washington, 98057, United States

  • Sansum Diabetes Research Institute

    Santa Barbara, California, 93105, United States

  • Tekton Research

    McKinney, Texas, 75069, United States

  • Texas Diabetes and Endocrinology

    Austin, Texas, 78731, United States

  • USF Diabetes Center

    Tampa, Florida, 33612, United States

  • Velocity Clinical Research

    Dallas, Texas, 75230, United States

  • Virginia Endocrinology Research

    Chesapeake, Virginia, 23321, United States

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