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This study is a single-arm, multi-center, Home and Hotel Clinical Investigation in pediatric subjects with type 1 diabetes on insulin pump therapy. The purpose of this study is to demonstrate that the closed loop algorithm is safe as part of the overall system, and to assess the PLGM feature in 7-13 years old subjects.
The study will proceed as follows:
Run-in Period - General:
A total of up to 200 subjects (age 2-13) will be enrolled at up to 15 investigational centers (14 in the US, 1 EMEA) in order to reach 120 subjects who will complete the HCL study.
Study Period - At Home:
Following the two week run-in period using the Study Pump (670G), all subjects (age 2-13) will participate in a 3-month study period.
Study Period - Hotel Study Subjects (age 7-13) will participate in a Hotel study (6 days, 5 nights), with the remainder of the study period to be spent at home. Subjects 2-6 years of age are not required to participate in a hotel study. Instead, they will participate in an out-of-home study for 5 consecutive days, 4-6 hours per day.
Continued Access Program Subjects will be given the opportunity to extend use of their study devices for a period of up to 3 years . If subjects choose to participate in the continuation period, they will retain the study devices at the end of study period visit or receive them back in the event they have been returned to study staff already.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hybrid closed loop | Experimental | All subjects will be wearing the MMT-670G insulin pump, using it with the closed loop algorithm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Pump | Device | Closed Loop Algorithm |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Age 2-13 Years Old Subjects Change in A1C | Descriptive analysis of change in A1C from baseline to end of 3-month study period | Baseline and end of 3-month study period |
| Measure | Description | Time Frame |
|---|---|---|
| Age 2-13 Years Old Subjects Mean Change in % of Time in Euglycemia (70-180 mg/dL) | mean change in % of time in Euglycemia (70-180 mg/dL) from baseline to 3 months study period | baseline and 3 months |
| Age 2-13 Years Old Subjects Mean Change in % of Time in Hyperglycemia (> 180 mg/dL) |
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Inclusion Criteria:
General Inclusion Criteria
Subject is age 2-13 years at time of screening
Subject has a clinical diagnosis of type 1 diabetes for 1 year or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
Subject age 2-6 years has a clinical diagnosis of type 1 diabetes for 3 months or more as determined via medical record or source documentation by an individual qualified to make a medical diagnosis
Study-specific inclusion criteria
Subject must have a minimum daily insulin requirement (Total Daily Dose) of greater than or equal to 8 units
Subjects 7-13: Subjects and their parent(s)/guardian(s) are willing to participate in an overnight visit at the end of the run-in period.
Subject 7-13 years of age and their parent(s)/guardian(s) are willing to participate in a hotel study for the specified duration of hotel stay.
Subject 2-6 years of age and their parent(s)/guardian(s) are willing to participate in an extended visit during the study period to perform Frequent Sample Testing.
Subject must have companion 18 years or older who will sleep in the same dwelling place every night during the study period. This requirement may be verified by subject report at screening visit.
Subject is willing to perform ≥ 4 finger stick blood glucose measurements daily
Subject is willing to perform required sensor calibrations
Subject is willing to wear the system continuously throughout the study
Subject has a Glycosylated hemoglobin (A1C) value less than 10.0% (as processed by Central Lab) at time of screening visit Note: All HbA1C blood specimens will be sent to and tested by a NGSP certified Central Laboratory. A1C testing must follow National Glycohemoglobin Standardization Program (NGSP) standards.
Subject has 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.
Subject 7 -13 years of age has had pump therapy for greater than 6 months prior to screening (with or without CGM experience)
Subject 2-6 years of age has had pump therapy for greater than 90 days prior to screening (with or without CGM experience)
Subjects and their parent(s)/guardian(s) are willing to upload data from the study pump; must have Internet access and a computer system that meets the requirements for uploading the study pump
If subject has celiac disease, it has been adequately treated as determined by the investigator
Subjects and their parent(s)/guardian(s) are willing to take one of the following insulins and can financially support the use of either of the 2 insulin preparations throughout the course of the study (i.e. co-payments for insulin with insurance or able to pay full amount)
Subjects and their parent(s)/guardian(s)/companions must be able to speak and be literate in English as verified by the investigator
Exclusion Criteria:
Subject has a history of 2 or more episodes of severe hypoglycemia, which resulted in any the following during the 6 months prior to screening:
Subject is unable to tolerate tape adhesive in the area of sensor placement
Subject has any unresolved adverse skin condition in the area of sensor placement (e.g., psoriasis, dermatitis herpetiformis, rash, Staphylococcus infection)
Females who are sexually active and able to conceive will be excluded if they are not using an effective method of contraception and do not agree to continue using an effective method of contraception for the duration of the study as determined by investigator.
Subject has a cardiovascular condition which the investigator determines should exclude the subject, i.e. ventricular rhythm disturbance, hypertrophic cardiomyopathy
Subject is being treated for hyperthyroidism at time of screening
Subject has diagnosis of adrenal insufficiency
Subject 7-13 years of age has had DKA in the 6 months prior to screening visit.
Subject 2-6 years of age has had DKA in the 3 months prior to screening visit
Subject 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
Subject 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
Subject 7-13 years of age has been hospitalized or has visited the ER in the 6 months prior to screening resulting in a primary diagnosis of uncontrolled diabetes
Subject 2-6 years of age has been hospitalized or has visited the ER in the 3 months prior to screening resulting in a primary diagnosis of uncontrolled diabetes
Subject is currently abusing illicit drugs
Subject is currently abusing marijuana.
Subject is currently abusing prescription drugs
Subject is currently abusing alcohol
Subject is using pramlintide (Symlin), DPP-4 inhibitor, liraglutide (Victoza or other GLP-1 agonists), metformin, canagliflozin (Invokana or other SGLT2 inhibitors) at time of screening
Subject 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
Subject has elective surgery planned that requires general anesthesia during the course of the study
Subject has a sickle cell disease, hemoglobinopathy; or has received red blood cell transfusion or erythropoietin within 3 months prior to time of screening
Subject plans to receive red blood cell transfusion or erythropoietin over the course of study participation
Subject diagnosed with current eating disorder such as anorexia or bulimia
Subject has been diagnosed with chronic kidney disease that results in chronic anemia
Subject has a hematocrit that is below the normal reference range of lab used.
Subject is on dialysis
Subject has serum creatinine of >2 mg/dL.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AMCR Institute | Escondido | California | 92025 | United States | ||
| Stanford Hospital and Clinics |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35001477 | Derived | Forlenza GP, Ekhlaspour L, DiMeglio LA, Fox LA, Rodriguez H, Shulman DI, Kaiserman KB, Liljenquist DR, Shin J, Lee SW, Buckingham BA. Glycemic outcomes of children 2-6 years of age with type 1 diabetes during the pediatric MiniMed 670G system trial. Pediatr Diabetes. 2022 May;23(3):324-329. doi: 10.1111/pedi.13312. Epub 2022 Jan 31. | |
| 30585770 |
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2-13 years subjects wearing MMT-670G insulin pump
151 subjects aged 2-13 years entered study period, 1 subject withdrawn during study period, 5 subjects didn't participate continued access period after finishing study period; 145 subjects aged 2-13 years entered continued access period, 25 subjects withdrawn and 120 subjects completed continued access period.
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| ID | Title | Description |
|---|---|---|
| FG000 | Subjects Wearing MMT-670G Insulin Pump | Subjects wearing MMT- 670G insulin pump during Study and Continued Access period |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| From Study to End of Continued Access |
|
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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 | Jan 29, 2019 | Aug 20, 2021 |
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mean change in % of time in hyperglycemia (> 180 mg/dL) from baseline to 3 months study period |
| baseline and 3 months |
| Age 2-13 Years Old Subjects Mean Change in % of Time in Hypoglycemia (<70 mg/dL) | mean change in % of time in hypoglycemia (< 70 mg/dL) from baseline to 3 months study period | baseline and 3 months |
| Age 2-13 Years Old - Number of Severe Hypoglycemic Event | Number of severe hypoglycemic events occurred during 3-month study period. | 3 months |
| Age 2-13 Years Old - Number of Diabetic Ketoacidosis (DKA) Event | Number of Diabetic Ketoacidosis (DKA) events occurred during 3-month study period. | 3 months |
| Age 7-13 Years Old Subjects PLGM Performance - Event Rate Without Hypoglycemia at YSI-FST <=65 mg/dL | Event rate without Hypoglycemia at YSI-FST <=65 mg/dL among 105 subjects who underwent the PLGM experiments. The event rate without hypoglycemia is the number of experiments without hypoglycemia/total number of experiments and hypoglycemic events are defined based on the occurrence of 2 or more continuous YSI-FST <= 65mg/dL during in-clinic procedures. | Up to 12 hours after the start of PLGM period |
| Palo Alto |
| California |
| 94305 |
| United States |
| SoCal Diabetes | Torrance | California | 90505 | United States |
| Barbara Davis Center | Aurora | Colorado | 80045 | United States |
| Nemours Children's Clinic | Jacksonville | Florida | 32207 | United States |
| University of South Florida - USF Health | Tampa | Florida | 33620 | United States |
| Atlanta Diabetes Associates | Atlanta | Georgia | 30318 | United States |
| Rocky Mountain Diabetes and Osteoporosis Center | Idaho Falls | Idaho | 83404 | United States |
| Indiana University | Indianapolis | Indiana | 46202 | United States |
| University of Michigan | Ann Arbor | Michigan | 48109 | United States |
| Sheba Medical Center | Tel Aviv | Israel |
| Forlenza GP, Pinhas-Hamiel O, Liljenquist DR, Shulman DI, Bailey TS, Bode BW, Wood MA, Buckingham BA, Kaiserman KB, Shin J, Huang S, Lee SW, Kaufman FR. Safety Evaluation of the MiniMed 670G System in Children 7-13 Years of Age with Type 1 Diabetes. Diabetes Technol Ther. 2019 Jan;21(1):11-19. doi: 10.1089/dia.2018.0264. Epub 2018 Dec 26. |
| COMPLETED |
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| NOT COMPLETED |
|
|
| Period 1: Study Period |
|
|
| Period 2: Continued Access Period |
|
|
2-13 Years old subjects wearing MMT-670G insulin pump
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| ID | Title | Description |
|---|---|---|
| BG000 | Age 2-13 Yrs | Age 2-13 Yrs Subjects wearing MMT- 670G insulin pump |
| 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 |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | participants |
| ||||||||||||||||||
| BMI (kg/m2) | One Subject's height and weight were not measured at enrollment. | Mean | Standard Deviation | kg/m^2 |
|
| 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 | Age 2-13 Years Old Subjects Change in A1C | Descriptive analysis of change in A1C from baseline to end of 3-month study period | 2-13 years old subjects wearing MMT-670G insulin pump; two subjects end of study A1C not collected. | Posted | Mean | Standard Deviation | percentage of hemoglobin | Baseline and end of 3-month study period |
|
|
| |||||||||||||||||||||||||
| Secondary | Age 2-13 Years Old Subjects Mean Change in % of Time in Euglycemia (70-180 mg/dL) | mean change in % of time in Euglycemia (70-180 mg/dL) from baseline to 3 months study period | 2-13 years old subjects wearing MMT-670G insulin pump. | Posted | Mean | Standard Deviation | Percentage of time | baseline and 3 months |
|
| ||||||||||||||||||||||||||
| Secondary | Age 2-13 Years Old Subjects Mean Change in % of Time in Hyperglycemia (> 180 mg/dL) | mean change in % of time in hyperglycemia (> 180 mg/dL) from baseline to 3 months study period | 2-13 years old subjects wearing MMT-670G insulin pump. | Posted | Mean | Standard Deviation | Percent of time | baseline and 3 months |
|
| ||||||||||||||||||||||||||
| Secondary | Age 2-13 Years Old Subjects Mean Change in % of Time in Hypoglycemia (<70 mg/dL) | mean change in % of time in hypoglycemia (< 70 mg/dL) from baseline to 3 months study period | 2-13 years old subjects wearing MMT-670G insulin pump. | Posted | Mean | Standard Deviation | percent of time | baseline and 3 months |
|
| ||||||||||||||||||||||||||
| Secondary | Age 2-13 Years Old - Number of Severe Hypoglycemic Event | Number of severe hypoglycemic events occurred during 3-month study period. | 2-13 years old subjects wearing MMT-670G insulin pump. | Posted | Number | events | 3 months |
|
| |||||||||||||||||||||||||||
| Secondary | Age 2-13 Years Old - Number of Diabetic Ketoacidosis (DKA) Event | Number of Diabetic Ketoacidosis (DKA) events occurred during 3-month study period. | 2-13 years old subjects wearing MMT-670G insulin pump. | Posted | Number | events | 3 months |
|
| |||||||||||||||||||||||||||
| Secondary | Age 7-13 Years Old Subjects PLGM Performance - Event Rate Without Hypoglycemia at YSI-FST <=65 mg/dL | Event rate without Hypoglycemia at YSI-FST <=65 mg/dL among 105 subjects who underwent the PLGM experiments. The event rate without hypoglycemia is the number of experiments without hypoglycemia/total number of experiments and hypoglycemic events are defined based on the occurrence of 2 or more continuous YSI-FST <= 65mg/dL during in-clinic procedures. | 7-13 years old subjects wearing MMT-670G insulin pump, participating in clinical evaluation of the suspend before low feature. | Posted | Number | percentage of total experiments | Up to 12 hours after the start of PLGM period |
|
|
3 months for Study period, up to 3 years for Continued Access 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 | Age 2-13 Yrs Study Period | 2-13 years old subjects wearing MMT-670G insulin pump during Study period. | 0 | 151 | 0 | 151 | 88 | 151 |
| EG001 | Age 2-13 Yrs Continued Access Period | 2-13 years old subjects wearing MMT-670G insulin pump during Continued Access period. | 0 | 145 | 4 | 145 | 113 | 145 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA 23.0 | Systematic Assessment |
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| Gastroenteritis | Infections and infestations | MedDRA 23.0 | Systematic Assessment |
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| Hypoglycaemic seizure | Nervous system disorders | MedDRA 23.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal pain | Gastrointestinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Abdominal pain upper | Gastrointestinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Abscess limb | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Acetonaemia | Metabolism and nutrition disorders | MedDRA23.0 | Systematic Assessment |
| |
| Acne | Skin and subcutaneous tissue disorders | MedDRA23.0 | Systematic Assessment |
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| Alopecia | Skin and subcutaneous tissue disorders | MedDRA23.0 | Systematic Assessment |
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| Arthropod bite | Injury, poisoning and procedural complications | MedDRA23.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Attention deficit hyperactivity disorder | Psychiatric disorders | MedDRA23.0 | Systematic Assessment |
| |
| Avulsion fracture | Injury, poisoning and procedural complications | MedDRA23.0 | Systematic Assessment |
| |
| Blood ketone body increased | Investigations | MedDRA23.0 | Systematic Assessment |
| |
| Breast cellulitis | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Cerumen impaction | Ear and labyrinth disorders | MedDRA23.0 | Systematic Assessment |
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| Coeliac disease | Gastrointestinal disorders | MedDRA23.0 | Systematic Assessment |
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| Concussion | Injury, poisoning and procedural complications | MedDRA23.0 | Systematic Assessment |
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| Conjunctivitis | Infections and infestations | MedDRA23.0 | Systematic Assessment |
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| Constipation | Gastrointestinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Contusion | Injury, poisoning and procedural complications | MedDRA23.0 | Systematic Assessment |
| |
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Croup infectious | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Dacryocanaliculitis | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Dehydration | Metabolism and nutrition disorders | MedDRA23.0 | Systematic Assessment |
| |
| Depression | Psychiatric disorders | MedDRA23.0 | Systematic Assessment |
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| Dermatitis | Skin and subcutaneous tissue disorders | MedDRA23.0 | Systematic Assessment |
| |
| Dermatitis allergic | Skin and subcutaneous tissue disorders | MedDRA23.0 | Systematic Assessment |
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| Dermatitis contact | Skin and subcutaneous tissue disorders | MedDRA23.0 | Systematic Assessment |
| |
| Diabetic ketoacidosis | Metabolism and nutrition disorders | MedDRA23.0 | Systematic Assessment |
| |
| Diarrhoea | Gastrointestinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Ear infection | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Ear pain | Ear and labyrinth disorders | MedDRA23.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA23.0 | Systematic Assessment |
| |
| Erythema | Skin and subcutaneous tissue disorders | MedDRA23.0 | Systematic Assessment |
| |
| Erythema infectiosum | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Folliculitis | Infections and infestations | MedDRA23.0 | Systematic Assessment |
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| Food allergy | Immune system disorders | MedDRA23.0 | Systematic Assessment |
| |
| Foot fracture | Injury, poisoning and procedural complications | MedDRA23.0 | Systematic Assessment |
| |
| Foreign body | Injury, poisoning and procedural complications | MedDRA23.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Gastroenteritis viral | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Gastrointestinal disorder | Gastrointestinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Gastrointestinal infection | Infections and infestations | MedDRA23.0 | Systematic Assessment |
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| Gastrointestinal viral infection | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Greenstick fracture | Injury, poisoning and procedural complications | MedDRA23.0 | Systematic Assessment |
| |
| Hand fracture | Injury, poisoning and procedural complications | MedDRA23.0 | Systematic Assessment |
| |
| Hand-foot-and-mouth disease | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA23.0 | Systematic Assessment |
| |
| Helicobacter test positive | Investigations | MedDRA23.0 | Systematic Assessment |
| |
| Herpangina | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Herpes zoster | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Humerus fracture | Injury, poisoning and procedural complications | MedDRA23.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA23.0 | Systematic Assessment |
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| Hypoglycaemia | Metabolism and nutrition disorders | MedDRA23.0 | Systematic Assessment |
| |
| Ill-defined disorder | General disorders | MedDRA23.0 | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Infectious mononucleosis | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Influenza like illness | General disorders | MedDRA23.0 | Systematic Assessment |
| |
| Infusion site haemorrhage | General disorders | MedDRA23.0 | Systematic Assessment |
| |
| Infusion site infection | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Injury associated with device | General disorders | MedDRA23.0 | Systematic Assessment |
| |
| Joint injury | Injury, poisoning and procedural complications | MedDRA23.0 | Systematic Assessment |
| |
| Ketosis | Metabolism and nutrition disorders | MedDRA23.0 | Systematic Assessment |
| |
| Laryngeal oedema | Respiratory, thoracic and mediastinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Ligament sprain | Injury, poisoning and procedural complications | MedDRA23.0 | Systematic Assessment |
| |
| Limb injury | Injury, poisoning and procedural complications | MedDRA23.0 | Systematic Assessment |
| |
| Lipoatrophy | Skin and subcutaneous tissue disorders | MedDRA23.0 | Systematic Assessment |
| |
| Lymphadenopathy | Blood and lymphatic system disorders | MedDRA23.0 | Systematic Assessment |
| |
| Medical device site abscess | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Medical device site infection | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Medical device site rash | General disorders | MedDRA23.0 | Systematic Assessment |
| |
| Medical device site reaction | General disorders | MedDRA23.0 | Systematic Assessment |
| |
| Meniscus injury | Injury, poisoning and procedural complications | MedDRA23.0 | Systematic Assessment |
| |
| Migraine | Nervous system disorders | MedDRA23.0 | Systematic Assessment |
| |
| Molluscum contagiosum | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Mouth ulceration | Gastrointestinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA23.0 | Systematic Assessment |
| |
| Musculoskeletal pain | Musculoskeletal and connective tissue disorders | MedDRA23.0 | Systematic Assessment |
| |
| Nasal congestion | Respiratory, thoracic and mediastinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Nasal polyps | Respiratory, thoracic and mediastinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Oral candidiasis | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Oropharyngeal pain | Respiratory, thoracic and mediastinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Osteochondrosis | Musculoskeletal and connective tissue disorders | MedDRA23.0 | Systematic Assessment |
| |
| Otitis externa | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Otitis media | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Otitis media acute | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA23.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA23.0 | Systematic Assessment |
| |
| Periumbilical abscess | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Pharyngitis | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Pharyngitis streptococcal | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Pityriasis rosea | Skin and subcutaneous tissue disorders | MedDRA23.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Presyncope | Nervous system disorders | MedDRA23.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA23.0 | Systematic Assessment |
| |
| Radius fracture | Injury, poisoning and procedural complications | MedDRA23.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA23.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA23.0 | Systematic Assessment |
| |
| Rhinitis allergic | Respiratory, thoracic and mediastinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Rhinovirus infection | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Scar | Injury, poisoning and procedural complications | MedDRA23.0 | Systematic Assessment |
| |
| Scarlet fever | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Scoliosis | Musculoskeletal and connective tissue disorders | MedDRA23.0 | Systematic Assessment |
| |
| Seasonal allergy | Immune system disorders | MedDRA23.0 | Systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Skin abrasion | Injury, poisoning and procedural complications | MedDRA23.0 | Systematic Assessment |
| |
| Skin infection | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Skin irritation | Skin and subcutaneous tissue disorders | MedDRA23.0 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA23.0 | Systematic Assessment |
| |
| Sleep apnoea syndrome | Respiratory, thoracic and mediastinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Staphylococcal abscess | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Subcutaneous abscess | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA23.0 | Systematic Assessment |
| |
| Temporomandibular joint syndrome | Musculoskeletal and connective tissue disorders | MedDRA23.0 | Systematic Assessment |
| |
| Tonsillitis | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Tonsillitis streptococcal | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Tooth abscess | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Tooth infection | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Torus fracture | Injury, poisoning and procedural complications | MedDRA23.0 | Systematic Assessment |
| |
| Upper limb fracture | Injury, poisoning and procedural complications | MedDRA23.0 | Systematic Assessment |
| |
| Upper respiratory tract congestion | Respiratory, thoracic and mediastinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA23.0 | Systematic Assessment |
| |
| Viral infection | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Viral pharyngitis | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Viral upper respiratory tract infection | Infections and infestations | MedDRA23.0 | Systematic Assessment |
| |
| Vomiting | Gastrointestinal disorders | MedDRA23.0 | Systematic Assessment |
| |
| Wrist fracture | Injury, poisoning and procedural complications | MedDRA23.0 | Systematic Assessment |
|
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vivian Chen, Statistician | Medtronic Minimed | 8185763309 | vivian.chen@medtronic.com |
| Prot_002.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 18, 2017 | Oct 12, 2018 | SAP_001.pdf |
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007332 | Insulin Infusion Systems |
| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
| D007260 | Infusion Pumps |
| D004864 | Equipment and Supplies |
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |
Not provided
Not provided
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
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|---|---|---|---|---|---|---|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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| Title | Denominators | Categories |
|---|
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| Title | Denominators | Categories |
|---|
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|