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.
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.
Show all 15Show fewer
- 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.
Show all 37Show fewer
- 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
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.
- Conditions
- Type 2 Diabetes Treated With Insulin
- 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 group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: MiniMed™ 780G Insulin Pump system |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
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
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
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
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)
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
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.
- First posted14 Feb 2022
- Study start25 Feb 2022
- Primary completion11 Jan 2025
- Study completion11 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 2 Diabetes Treated With InsulinStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Medtronic MiniMed, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05238142
- Acronym / sponsor ID
- CIP341
- Conditions
- Type 2 Diabetes Treated With Insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 574 participants (actual)
- Lead sponsor
- Medtronic MiniMed, Inc.Industry (pharma, biotech, devices)
- Study start
- 25 Feb 2022 (actual)
- Primary completion
- 11 Jan 2025 (actual)
- Study completion
- 11 Jan 2025 (actual)
- First posted
- 14 Feb 2022 (actual)
- Results
- Posted 16 Apr 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MiniMed 780G System | Experimental | Device: MiniMed™ 780G Insulin Pump systemAdult 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- 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.
Key exclusion criteria (37 listed)
- Has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to screening:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MiniMed™ 780G Insulin Pump systemMiniMed 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) | Device | MiniMed 780G System |
Primary outcome
Primary Safety Endpoint - Change in HbA1c Phase 1
Time frame: Baseline and end of 3-month study period
The overall mean change in HbA1c from baseline to end of 3-month study period. Non-inferiority test.
Primary Effectiveness Endpoint - Percent of Time in Range (TIR 70-180 mg/dL) Phase 1
Time frame: Last 6 weeks of 3 month study period
The mean percent of time in range (TIR 70-180 mg/dL). Non-inferiority test.
Primary Safety Endpoint - Change in HbA1c Phase 2 Transition
Time frame: Baseline and end of 3-month study period
The overall mean change in HbA1c from baseline to end of 3-month study period. Non-inferiority test.
Primary Safety Endpoint - Change in HbA1c Phase 2 Naive
Time frame: Baseline and end of 3-month study period
The overall mean change in HbA1c from baseline to end of 3-month study period. Non-inferiority test.
Primary Effectiveness Endpoint - Percent of Time in Range (TIR 70-180 mg/dL) Phase 2 Transition + Naive
Time frame: Last 6 weeks of 3 month study period
The mean percent of time in range (TIR 70-180 mg/dL). Non-inferiority test.
2 secondary outcomes
Secondary Effectiveness Endpoint - Percent of Time in Range (TIR 70-180 mg/dL) Phase 1
Time frame: 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
Time frame: Last 6 weeks of 3 month study period
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39912797Bhargava 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
31 sites in 1 country: see every site and its status.
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.