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The objective of the study is to assess the safety and effectiveness of MiniMedâ„¢ 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.
Phase 1 of the study, will utilize the MiniMedâ„¢ 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 MiniMedâ„¢ 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MiniMedâ„¢ 780G Insulin Pump system | Device | MiniMed 780G insulin pump with Guardian 4 sensor (phase 1) MiniMedâ„¢ 780G BLE 2.0 insulin pump used in combination with Disposable Sensor 5 (phase 2) |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 |
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Inclusion Criteria:
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:
Exclusion Criteria:
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.
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).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Investigations | Little Rock | Arkansas | 72211 | United States | ||
| Headlands Research California LLC |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39912797 | Derived | 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. |
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574 subjects (165 from Phase 1 and 409 from Phase 2) enrolled at the beginning, with 193 (58 from Phase 1 and 135 from Phase 2) screen failures, 50 subjects (12 from Phase 1 and 38 from Phase 2) early withdrawn, 331 subjects (95 from Phase 1 and 236 from Phase 2 ) were left as the Intention to Treat Population and started the study period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Phase 1 | Phase 1 studied the MiniMedâ„¢ 780G insulin pump with Guardian 4 Sensor. Only the results for the Intention-to-Treat (ITT) population are included. |
| FG001 | Phase 2 | Phase 2 studied the MiniMedâ„¢ 780G BLE 2.0 insulin pump with the disposable sensor DS5. Only the results for the Intention-to-Treat (ITT) population are included. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Phase 1 Study Period |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Apr 8, 2024 | Dec 8, 2025 |
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The mean percent of time in range (TIR 70-180 mg/dL). Superiority test. |
| Last 6 weeks of 3 month study period |
| Escondido |
| California |
| 92025 |
| United States |
| Loma Linda University Medical Center | Loma Linda | California | 92354 | United States |
| Hoag Hospital Newport Beach | Newport Beach | California | 92663 | United States |
| Mills-Peninsula Medical Center: Diabetes Research Institute | San Mateo | California | 94401 | United States |
| Sansum Diabetes Research Institute | Santa Barbara | California | 93105 | United States |
| East Coast Institute for Research | Jacksonville | Florida | 32204 | United States |
| USF Diabetes Center | Tampa | Florida | 33612 | United States |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30318 | United States |
| East Coast Institute for Research | Canton | Georgia | 30114 | United States |
| East Coast Institute for Research | Macon | Georgia | 31210 | United States |
| Endocrine Research Solutions | Roswell | Georgia | 30076 | United States |
| Javara | Thomasville | Georgia | 31792 | United States |
| NorthShore University Health System | Skokie | Illinois | 60077 | United States |
| Iowa Diabetes Research | West Des Moines | Iowa | 50265 | United States |
| MedStar Good Samaritan Hospital | Baltimore | Maryland | 21239 | United States |
| Endocrine & Metabolic Consultants | Rockville | Maryland | 20852 | United States |
| Park Nicollet International Diabetes Center | Saint Louis Park | Minnesota | 55416 | United States |
| Bryan Health | Lincoln | Nebraska | 68506 | United States |
| Atlantic Health System | Morristown | New Jersey | 07962 | United States |
| NYC Research Inc | Long Island City | New York | 11106 | United States |
| Northwell Health Physician Partners Endocrinology | New York | New York | 10022 | United States |
| Physicians East | Greenville | North Carolina | 27834 | United States |
| Texas Diabetes and Endocrinology | Austin | Texas | 78731 | United States |
| Javara | Conroe | Texas | 77384 | United States |
| Velocity Clinical Research | Dallas | Texas | 75230 | United States |
| Prime Revival Research Institute | Flower Mound | Texas | 75028 | United States |
| Houston Methodist Research Institute | Houston | Texas | 77030 | United States |
| Tekton Research | McKinney | Texas | 75069 | United States |
| Virginia Endocrinology Research | Chesapeake | Virginia | 23321 | United States |
| Rainier Clinical Research Center | Renton | Washington | 98057 | United States |
| COMPLETED |
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| NOT COMPLETED |
|
|
| Phase 1 Continuation Period |
|
|
| Phase 2 Study Period-Transition + Naive |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Phase 1 | Phase 1 studied the MiniMedâ„¢ 780G insulin pump with Guardian 4 Sensor. Only the results for the Intention-to-Treat (ITT) population are included. |
| BG001 | Phase 2 Naive | Phase 2 studied the MiniMedâ„¢ 780G BLE 2.0 insulin pump with the disposable sensor DS5. Only the results for the Intention-to-Treat (ITT) population are included. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Study period: 95 subjects in Phase 1. 88 subjects have available measurements. | Posted | Mean | 95% Confidence Interval | Percentage of HbA1c | Baseline and end of 3-month study period |
|
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| Primary | 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. | Study period: 95 subjects in Phase 1. 91 subjects have available measurements. | Posted | Mean | 95% Confidence Interval | Percentage of TIR | Last 6 weeks of 3 month study period |
|
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| Primary | 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. | Study period: 66 subjects in Phase 2 Transition. 65 subjects have available measurements. | Posted | Mean | 95% Confidence Interval | Percentage of HbA1c | Baseline and end of 3-month study period |
|
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| Primary | 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. | Study period: 236 subjects in Phase 2 Naive. 229 subjects have available measurements. | Posted | Mean | 95% Confidence Interval | Percentage of HbA1c | Baseline and end of 3-month study period |
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| Primary | 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. | Study period: 302 subjects in Phase 2 Transition + Naive. 298 subjects have available measurements. | Posted | Mean | 95% Confidence Interval | Percentage of TIR | Last 6 weeks of 3 month study period |
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| Secondary | 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. | Study period: 95 subjects in Phase 1. 91 subjects have available measurements. | Posted | Mean | 95% Confidence Interval | Percentage of TIR | Last 6 weeks of 3 month study period |
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| Secondary | 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. | Study period: 302 subjects in Phase 2 Transition + Naive. 298 subjects have available measurements. | Posted | Mean | 95% Confidence Interval | Percentage of TIR | Last 6 weeks of 3 month study period |
|
|
Phase 1 naive participants were assessed for up to 3 months of the Phase 1 Study Period. Phase 2 participants (naive and transition) were assessed for up to 3 months of the Phase 2 Study Period.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Phase 1 | Phase 1 studied the MiniMedâ„¢ 780G insulin pump with Guardian 4 Sensor. Only the results for the Intention-to-Treat (ITT) population are included. | 0 | 95 | 3 | 95 | 40 | 95 |
| EG001 | Phase 2 | Phase 2 studied the MiniMedâ„¢ 780G BLE 2.0 insulin pump with the disposable sensor DS5. Only the results for the Intention-to-Treat (ITT) population are included. | 1 | 302 | 10 | 302 | 114 | 302 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Acute myocardial infarction | Cardiac disorders | MedDRA27.0 | Systematic Assessment |
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| Bradycardia | Cardiac disorders | MedDRA27.0 | Systematic Assessment |
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| Myocardial infarction | Cardiac disorders | MedDRA27.0 | Systematic Assessment |
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| Gastrointestinal haemorrhage | Gastrointestinal disorders | MedDRA27.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders and administration site conditions | MedDRA27.0 | Systematic Assessment |
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| Unevaluable event | General disorders and administration site conditions | MedDRA27.0 | Systematic Assessment |
| |
| Device related infection | Infections and infestations | MedDRA27.0 | Systematic Assessment |
| |
| Osteomyelitis | Infections and infestations | MedDRA27.0 | Systematic Assessment |
| |
| Pyelonephritis | Infections and infestations | MedDRA27.0 | Systematic Assessment |
| |
| Septic shock | Infections and infestations | MedDRA27.0 | Systematic Assessment |
| |
| Wound infection staphylococcal | Infections and infestations | MedDRA27.0 | Systematic Assessment |
| |
| Hypertensive emergency | Vascular disorders | MedDRA27.0 | Systematic Assessment |
| |
| Hypertensive urgency | Vascular disorders | MedDRA27.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA27.0 | Systematic Assessment |
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| Palpitations | Cardiac disorders | MedDRA27.0 | Systematic Assessment |
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| Postural orthostatic tachycardia syndrome | Cardiac disorders | MedDRA27.0 | Systematic Assessment |
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| Sinus tachycardia | Cardiac disorders | MedDRA27.0 | Systematic Assessment |
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| Ventricular arrhythmia | Cardiac disorders | MedDRA27.0 | Systematic Assessment |
| |
| Hypertrophic cardiomyopathy | Congenital, familial and genetic disorders | MedDRA27.0 | Systematic Assessment |
| |
| Tinnitus | Ear and labyrinth disorders | MedDRA27.0 | Systematic Assessment |
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| Hypothyroidism | Endocrine disorders | MedDRA27.0 | Systematic Assessment |
| |
| Thyroid mass | Endocrine disorders | MedDRA27.0 | Systematic Assessment |
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| Angle closure glaucoma | Eye disorders | MedDRA27.0 | Systematic Assessment |
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| Cataract | Eye disorders | MedDRA27.0 | Systematic Assessment |
| |
| Diabetic retinal oedema | Eye disorders | MedDRA27.0 | Systematic Assessment |
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| Diabetic retinopathy | Eye disorders | MedDRA27.0 | Systematic Assessment |
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| Dry eye | Eye disorders | MedDRA27.0 | Systematic Assessment |
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| Glaucoma | Eye disorders | MedDRA27.0 | Systematic Assessment |
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| Trichiasis | Eye disorders | MedDRA27.0 | Systematic Assessment |
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| Vitreous haemorrhage | Eye disorders | MedDRA27.0 | Systematic Assessment |
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| Abdominal distension | Gastrointestinal disorders | MedDRA27.0 | Systematic Assessment |
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| Abdominal pain lower | Gastrointestinal disorders | MedDRA27.0 | Systematic Assessment |
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| Abdominal pain upper | Gastrointestinal disorders | MedDRA27.0 | Systematic Assessment |
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| Aphthous ulcer | Gastrointestinal disorders | MedDRA27.0 | Systematic Assessment |
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| Colitis | Gastrointestinal disorders | MedDRA27.0 | Systematic Assessment |
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| Dental caries | Gastrointestinal disorders | MedDRA27.0 | Systematic Assessment |
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| Diarrhoea | Gastrointestinal disorders | MedDRA27.0 | Systematic Assessment |
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| Flatulence | Gastrointestinal disorders | MedDRA27.0 | Systematic Assessment |
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| Gastrooesophageal reflux disease | Gastrointestinal disorders | MedDRA27.0 | Systematic Assessment |
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| Haematemesis | Gastrointestinal disorders | MedDRA27.0 | Systematic Assessment |
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| Haemorrhoids | Gastrointestinal disorders | MedDRA27.0 | Systematic Assessment |
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| Large intestine polyp | Gastrointestinal disorders | MedDRA27.0 | Systematic Assessment |
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| Mouth cyst | Gastrointestinal disorders | MedDRA27.0 | Systematic Assessment |
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| Nausea | Gastrointestinal disorders | MedDRA27.0 | Systematic Assessment |
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| Vomiting | Gastrointestinal disorders | MedDRA27.0 | Systematic Assessment |
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| Chest discomfort | General disorders and administration site conditions | MedDRA27.0 | Systematic Assessment |
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| Chest pain | General disorders and administration site conditions | MedDRA27.0 | Systematic Assessment |
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| Fatigue | General disorders and administration site conditions | MedDRA27.0 | Systematic Assessment |
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| Infusion site bruising | General disorders and administration site conditions | MedDRA27.0 | Systematic Assessment |
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| Infusion site dermatitis | General disorders and administration site conditions | MedDRA27.0 | Systematic Assessment |
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| Infusion site reaction | General disorders and administration site conditions | MedDRA27.0 | Systematic Assessment |
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| Infusion site swelling | General disorders and administration site conditions | MedDRA27.0 | Systematic Assessment |
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| Injection site reaction | General disorders and administration site conditions | MedDRA27.0 | Systematic Assessment |
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| Malaise | General disorders and administration site conditions | MedDRA27.0 | Systematic Assessment |
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| Medical device site bruise | General disorders and administration site conditions | MedDRA27.0 | Systematic Assessment |
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| Medical device site discolouration | General disorders and administration site conditions | MedDRA27.0 | Systematic Assessment |
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| Medical device site erythema | General disorders and administration site conditions | MedDRA27.0 | Systematic Assessment |
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| Medical device site haemorrhage | General disorders and administration site conditions | MedDRA27.0 | Systematic Assessment |
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| Medical device site irritation | General disorders and administration site conditions | MedDRA27.0 | Systematic Assessment |
| |
| Medical device site mass | General disorders and administration site conditions | MedDRA27.0 | Systematic Assessment |
| |
| Medical device site pain | General disorders and administration site conditions | MedDRA27.0 | Systematic Assessment |
| |
| Medical device site pruritus | General disorders and administration site conditions | MedDRA27.0 | Systematic Assessment |
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| Medical device site rash | General disorders and administration site conditions | MedDRA27.0 | Systematic Assessment |
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| Medical device site reaction | General disorders and administration site conditions | MedDRA27.0 | Systematic Assessment |
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| Medical device site swelling | General disorders and administration site conditions | MedDRA27.0 | Systematic Assessment |
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| Oedema peripheral | General disorders and administration site conditions | MedDRA27.0 | Systematic Assessment |
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| Pain | General disorders and administration site conditions | MedDRA27.0 | Systematic Assessment |
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| Pyrexia | General disorders and administration site conditions | MedDRA27.0 | Systematic Assessment |
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| Ulcer | General disorders and administration site conditions | MedDRA27.0 | Systematic Assessment |
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| Anaphylactic reaction | Immune system disorders | MedDRA27.0 | Systematic Assessment |
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| Bronchitis | Infections and infestations | MedDRA27.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA27.0 | Systematic Assessment |
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| Cellulitis | Infections and infestations | MedDRA27.0 | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA27.0 | Systematic Assessment |
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| Conjunctivitis bacterial | Infections and infestations | MedDRA27.0 | Systematic Assessment |
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| Cystitis | Infections and infestations | MedDRA27.0 | Systematic Assessment |
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| Diverticulitis | Infections and infestations | MedDRA27.0 | Systematic Assessment |
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| Ear infection | Infections and infestations | MedDRA27.0 | Systematic Assessment |
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| Epididymitis | Infections and infestations | MedDRA27.0 | Systematic Assessment |
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| Folliculitis | Infections and infestations | MedDRA27.0 | Systematic Assessment |
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| Fungal infection | Infections and infestations | MedDRA27.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA27.0 | Systematic Assessment |
| |
| Hordeolum | Infections and infestations | MedDRA27.0 | Systematic Assessment |
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| Influenza | Infections and infestations | MedDRA27.0 | Systematic Assessment |
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| Localised infection | Infections and infestations | MedDRA27.0 | Systematic Assessment |
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| Lower respiratory tract infection | Infections and infestations | MedDRA27.0 | Systematic Assessment |
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| Medical device site infection | Infections and infestations | MedDRA27.0 | Systematic Assessment |
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| Medical device site pustule | Infections and infestations | MedDRA27.0 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MedDRA27.0 | Systematic Assessment |
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| Otitis media | Infections and infestations | MedDRA27.0 | Systematic Assessment |
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| Pharyngitis | Infections and infestations | MedDRA27.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA27.0 | Systematic Assessment |
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| Pneumonia | Infections and infestations | MedDRA27.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA27.0 | Systematic Assessment |
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| Sinusitis bacterial | Infections and infestations | MedDRA27.0 | Systematic Assessment |
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| Skin infection | Infections and infestations | MedDRA27.0 | Systematic Assessment |
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| Tooth infection | Infections and infestations | MedDRA27.0 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MedDRA27.0 | Systematic Assessment |
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| Urinary tract infection | Infections and infestations | MedDRA27.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA27.0 | Systematic Assessment |
| |
| Vulvovaginal candidiasis | Infections and infestations | MedDRA27.0 | Systematic Assessment |
| |
| Arthropod sting | Injury, poisoning and procedural complications | MedDRA27.0 | Systematic Assessment |
| |
| Bone contusion | Injury, poisoning and procedural complications | MedDRA27.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA27.0 | Systematic Assessment |
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| Fall | Injury, poisoning and procedural complications | MedDRA27.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA27.0 | Systematic Assessment |
| |
| Muscle strain | Injury, poisoning and procedural complications | MedDRA27.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA27.0 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA27.0 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA27.0 | Systematic Assessment |
| |
| Stress fracture | Injury, poisoning and procedural complications | MedDRA27.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA27.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA27.0 | Systematic Assessment |
| |
| Gout | Metabolism and nutrition disorders | MedDRA27.0 | Systematic Assessment |
| |
| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA27.0 | Systematic Assessment |
| |
| Vitamin D deficiency | Metabolism and nutrition disorders | MedDRA27.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA27.0 | Systematic Assessment |
| |
| Arthritis | Musculoskeletal and connective tissue disorders | MedDRA27.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA27.0 | Systematic Assessment |
| |
| Exostosis | Musculoskeletal and connective tissue disorders | MedDRA27.0 | Systematic Assessment |
| |
| Intervertebral disc protrusion | Musculoskeletal and connective tissue disorders | MedDRA27.0 | Systematic Assessment |
| |
| Joint range of motion decreased | Musculoskeletal and connective tissue disorders | MedDRA27.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA27.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA27.0 | Systematic Assessment |
| |
| Osteoarthritis | Musculoskeletal and connective tissue disorders | MedDRA27.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA27.0 | Systematic Assessment |
| |
| Plantar fasciitis | Musculoskeletal and connective tissue disorders | MedDRA27.0 | Systematic Assessment |
| |
| Tendonitis | Musculoskeletal and connective tissue disorders | MedDRA27.0 | Systematic Assessment |
| |
| Trigger finger | Musculoskeletal and connective tissue disorders | MedDRA27.0 | Systematic Assessment |
| |
| Acrochordon | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA27.0 | Systematic Assessment |
| |
| Basal cell carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA27.0 | Systematic Assessment |
| |
| Prostate cancer recurrent | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA27.0 | Systematic Assessment |
| |
| Carpal tunnel syndrome | Nervous system disorders | MedDRA27.0 | Systematic Assessment |
| |
| Cluster headache | Nervous system disorders | MedDRA27.0 | Systematic Assessment |
| |
| Diabetic neuropathy | Nervous system disorders | MedDRA27.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA27.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA27.0 | Systematic Assessment |
| |
| Neuropathy peripheral | Nervous system disorders | MedDRA27.0 | Systematic Assessment |
| |
| Petit mal epilepsy | Nervous system disorders | MedDRA27.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA27.0 | Systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA27.0 | Systematic Assessment |
| |
| Attention deficit hyperactivity disorder | Psychiatric disorders | MedDRA27.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA27.0 | Systematic Assessment |
| |
| Acute kidney injury | Renal and urinary disorders | MedDRA27.0 | Systematic Assessment |
| |
| Chronic kidney disease | Renal and urinary disorders | MedDRA27.0 | Systematic Assessment |
| |
| Nephropathy | Renal and urinary disorders | MedDRA27.0 | Systematic Assessment |
| |
| Renal impairment | Renal and urinary disorders | MedDRA27.0 | Systematic Assessment |
| |
| Urine flow decreased | Renal and urinary disorders | MedDRA27.0 | Systematic Assessment |
| |
| Benign prostatic hyperplasia | Reproductive system and breast disorders | MedDRA27.0 | Systematic Assessment |
| |
| Erectile dysfunction | Reproductive system and breast disorders | MedDRA27.0 | Systematic Assessment |
| |
| Chronic obstructive pulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA27.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA27.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA27.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA27.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA27.0 | Systematic Assessment |
| |
| Pulmonary oedema | Respiratory, thoracic and mediastinal disorders | MedDRA27.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA27.0 | Systematic Assessment |
| |
| Sinus congestion | Respiratory, thoracic and mediastinal disorders | MedDRA27.0 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA27.0 | Systematic Assessment |
| |
| Angioedema | Skin and subcutaneous tissue disorders | MedDRA27.0 | Systematic Assessment |
| |
| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA27.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA27.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA27.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA27.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA27.0 | Systematic Assessment |
| |
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA27.0 | Systematic Assessment |
| |
| Skin ulcer | Skin and subcutaneous tissue disorders | MedDRA27.0 | Systematic Assessment |
| |
| Deep vein thrombosis | Vascular disorders | MedDRA27.0 | Systematic Assessment |
| |
| Hot flush | Vascular disorders | MedDRA27.0 | Systematic Assessment |
|
PI agrees not to publish until 12 months from trial completion or until sponsor publishes multi-center results, whichever occurs first. In either case, sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period more than 60 days but less than or equal to 180 days from the date that the communication is submitted to sponsor for review. Sponsor cannot require changes ot he communication and cannot extend the embargo.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Troub, Sr Clinical Research Manager | Medtronic Diabetes | 1-800-646-4633 | thomas.troub@medtronic.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 11, 2024 | Dec 8, 2025 | SAP_001.pdf |
Not provided
| Protocol Violation |
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| Withdrawal by Subject |
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| Lost to Follow-up |
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| Patient was discharged from clinic and was not able to come back onsite for visits. |
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| Protocol Violation |
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| Withdrawal by Subject |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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