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This is an exploratory, single-center, randomized, open label, active-controlled, complete cross-over trial comparing safety and efficacy of Fiasp® versus NovoLog® when used in the Medtronic MiniMed 670G system in subjects with T1DM.
This study is being performed to compare Fiasp® in terms of glycemic control with a focus on post-prandial 1-hour plasma glucose level and system-based outcomes to NovoLog® insulin when used in the Medtronic mini Med 670G HCL system (operating in auto-mode) in patients with type 1 diabetes. The investigator's hypothesis is that post prandial glucoses will be lower and time in range will be greater during the Fiasp® treatment period.
Subjects will have a 2 week screening period, 14 week treatment period and 30 Day follow up period. After at least 7 weeks on treatment period one they will crossover to treatment period two on the opposite treatment for 7 additional weeks.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fiasp/Novolog | Experimental | 7 weeks on Fiasp® then crossover to 7 weeks on Novolog® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion |
|
| Novolog/Fiasp | Experimental | 7 weeks on Novolog® then crossover to 7 weeks on Fiasp® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fiasp® | Drug | Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system |
|
| Measure | Description | Time Frame |
|---|---|---|
| 1-Hour Change in Postprandial Plasma Glucose (PPG) | Change was calculated as the PPG value at 1 hour minus the PPG value at baseline (time -2 minutes) during meal test | 6th week of therapy |
| Measure | Description | Time Frame |
|---|---|---|
| 2-Hour Change in Postprandial Plasma Glucose (PPG) | Change was calculated as the value at 2 hour minus the value at baseline during meal test | 6th week of therapy |
| Percentage of Time Spent Between Below 70 mg/dL |
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Inclusion Criteria:
Exclusion Criteria:
Known or suspected hypersensitivity to trial products or related products
Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using adequate contraceptive methods (adequate contraceptive measures as required by local regulation or practice)
Participation in another clinical trial within 28 days before the screening visit. Note: clinical trials do not include non-interventional studies
Anticipated significant change in lifestyle (e.g. eating, exercise or sleeping pattern) throughout the trial
Any of the following: myocardial infarction, stroke, hospitalization for unstable angina or transient ischemic attack within the past 180 days prior to the day of screening
Subjects classified as being in New York Heart Association (NYHA) Class IV at screening
Planned coronary, carotid or peripheral artery revascularization known on the day of screening.
Inadequately treated blood pressure defined as Grade 3 hypertension or higher (Systolic
≥180 mmHg or diastolic ≥110 mmHg) at screening
Impaired liver function, defined as ALT ≥ 2.5 times upper normal limit at screening
Renal impairment measured as estimated Glomerular Filtration Rate (eGFR) value of < 45 ml/min/1.73 m2
Anticipated initiation or change in concomitant medications (for more than 14 consecutive days) known to affect weight or glucose metabolism in the opinion of the Investigator
Proliferative retinopathy or maculopathy requiring acute treatment at the time of screening
History of hospitalization for ketoacidosis ≤180 days prior to the day of screening
Treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 30 days before screening
Presence of malignant neoplasms at the time of screening. Basal and squamous cell skin cancer and any carcinoma in-situ is allowed.
Reoccurring Severe hypoglycemia while on the Medtronic Minimed 670G in the investigators opinion
Any condition which, in the opinion of the Investigator, might jeopardize Subject's safety or compliance with the protocol
-
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| Name | Affiliation | Role |
|---|---|---|
| Thomas Blevins, MD | Texas Diabetes & Endocrinology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Texas Diabetes & Endocrinology | Austin | Texas | 78731 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33090016 | Derived | Ozer K, Cooper AM, Ahn LP, Waggonner CR, Blevins TC. Fast Acting Insulin Aspart Compared with Insulin Aspart in the Medtronic 670G Hybrid Closed Loop System in Type 1 Diabetes: An Open Label Crossover Study. Diabetes Technol Ther. 2021 Apr;23(4):286-292. doi: 10.1089/dia.2020.0500. Epub 2021 Mar 8. |
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40 of 45 participants were randomized. All 5 who were not randomized did not meet inclusion criteria.
45 patients were screened for eligibility between June 11,2019 and November 21, 2019 at a diabetes clinic in Austin, TX
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| ID | Title | Description |
|---|---|---|
| FG000 | Fiasp/Novolog | 7 weeks on Fiasp® then crossover to 7 weeks on Novolog® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion Fiasp®: Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system Novolog®: Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system 670G hybrid closed loop continuous subcutaneous insulin infusion system: CSII |
| FG001 | Novolog/Fiasp | 7 weeks on Novolog® then crossover to 7 weeks on Fiasp® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion Fiasp®: Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system Novolog®: Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system 670G hybrid closed loop continuous subcutaneous insulin infusion system: CSII |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Treatment |
| ||||||||||||||||
| Second Treatment |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Fiasp/Novolog | 7 weeks on Fiasp® then crossover to 7 weeks on Novolog® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion Fiasp®: Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system Novolog®: Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system 670G hybrid closed loop continuous subcutaneous insulin infusion system: CSII |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | 1-Hour Change in Postprandial Plasma Glucose (PPG) | Change was calculated as the PPG value at 1 hour minus the PPG value at baseline (time -2 minutes) during meal test | All patients who participated in the meal test after 6 weeks of therapy in each arm | Posted | Mean | Standard Deviation | mg/dL | 6th week of therapy |
|
Approximately 20 weeks. The entire duration of the subjects study period.
Adverse event information was collected at all phone or office visits during the trial.
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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 | Fiasp/Novolog | 7 weeks on Fiasp® then crossover to 7 weeks on Novolog® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion Fiasp®: Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system Novolog®: Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system 670G hybrid closed loop continuous subcutaneous insulin infusion system: CSII |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Herniated Disc | Musculoskeletal and connective tissue disorders | Systematic Assessment | Subject hospitalized for laminectomy to repair herniated disc |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Non Proliferative Diabetic Retinopathy | Eye disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Thomas Blevins, MD | Texas Diabetes & Endocrinology | 512-334-3505 | 1 | blevins@texasdiabetes.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 16, 2019 | May 31, 2020 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D061267 | Insulin Aspart |
| ID | Term |
|---|---|
| D061266 | Insulin, Short-Acting |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Novolog® | Drug | Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system |
|
|
| 670G hybrid closed loop continuous subcutaneous insulin infusion system | Device | CSII |
|
|
Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each)
| Weeks 1 through 6, Weeks 8 through 13 |
| Percentage of Time Spent Between 70 mg/dL and 180 mg/dL | Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each) | Weeks 1 through 6, Weeks 8 through 13 |
| Percentage of Time Spent Above 200 mg/dL | Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each) | Weeks 1 through 6, Weeks 8 through 13 |
| Percentage of Time Spent in Hypoglycemia (40 mg/dL - 54 mg/dL) | Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each) | Weeks 1 through 6, Weeks 8 through 13 |
| Percentage of Time Spent in Severe Hypoglycemia (> 40 mg/dL) | Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each) | Weeks 1 through 6, Weeks 8 through 13 |
| 1,5 Anhydroglucitol Levels | 1,5 anhydroglucitol levels were measured on the 6th week of each therapy | Week 6, Week 13 |
| Fructosamine Levels | Cumulative glycemic control expressed in fructosamine levels (micromol/Liter) were measured on the 6th week of each therapy | Week 6, Week 13 |
| HbA1c | Cumulative glycemic control expressed in HbA1c% measured on the 6th week of each therapy | Week 6, Week 13 |
| Insulin Use - Change in Daily Dose | Change was calculated as the value on the last day of therapy minus the value on the 1st day of therapy in each period | Weeks 1 through 6, Weeks 8 through 13 |
| Insulin Use - Bolus | Change in %bolus insulin (units) as the value on the last day of therapy minus the value on the 1st day of therapy in each period | Weeks 1 through 6, Weeks 8 through 13 |
| Insulin Use - Basal | Change in %basal insulin (units) as the value on the last day of therapy minus the value on the 1st day of therapy in each period | Weeks 1 through 6, Weeks 8 through 13 |
| Insulin Use - Automatic Basal Insulin | Average amount per day (units) calculated for each participant under each therapy | Weeks 1 through 6, Weeks 8 through 13 |
| Insulin Pump - Active Insulin Time | Average time per day (hours) calculated for each participant under each therapy | Weeks 1 through 6, Weeks 8 through 13 |
| Insulin Pump - Auto Mode | Percentage of time spent in auto-mode after calibration under each therapy | Weeks 3 through 6, Weeks 10 through 13 |
| Insulin Pump - Manual Mode | Percentage of time spent in manual-mode after calibration under each therapy | Weeks 3 through 6, Weeks 10 through 13 |
| Change in Carbohydrate Ratio | Change was calculated as the carbohydrate ratio on the last day of therapy minus the carbohydrate ratio on the 1st day of therapy in each period | Weeks 1 through 6, Weeks 8 through 13 |
| Infusion Site Reactions | Number of Infusion site reactions reported by patient | 14 week treatment period |
| Pump Occlusions | Number of Occlusion events reported by patient | 14 week treatment period |
| NOT COMPLETED |
|
|
| BG001 | Novolog/Fiasp | 7 weeks on Novolog® then crossover to 7 weeks on Fiasp® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion Fiasp®: Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system Novolog®: Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system 670G hybrid closed loop continuous subcutaneous insulin infusion system: CSII |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BMI | Mean | Standard Deviation | kg/m^2 |
|
| Weight | Mean | Standard Deviation | kg |
|
| Height | Mean | Standard Deviation | cm |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| Secondary | 2-Hour Change in Postprandial Plasma Glucose (PPG) | Change was calculated as the value at 2 hour minus the value at baseline during meal test | All patients who participated in the meal test after 6 weeks of therapy in each arm | Posted | Mean | Standard Error | mg/dL | 6th week of therapy |
|
|
|
|
| Secondary | Percentage of Time Spent Between Below 70 mg/dL | Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each) | All patients for whom continuous glucose monitoring data was available during the specified time periods | Posted | Mean | Standard Deviation | percentage of time | Weeks 1 through 6, Weeks 8 through 13 |
|
|
|
|
| Secondary | Percentage of Time Spent Between 70 mg/dL and 180 mg/dL | Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each) | All patients for whom continuous glucose monitoring data was available during the specified time periods | Posted | Mean | Standard Deviation | percentage of time | Weeks 1 through 6, Weeks 8 through 13 |
|
|
|
|
| Secondary | Percentage of Time Spent Above 200 mg/dL | Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each) | All patients for whom continuous glucose monitoring data was available during the specified time periods | Posted | Mean | Standard Deviation | percentage of time | Weeks 1 through 6, Weeks 8 through 13 |
|
|
|
|
| Secondary | Percentage of Time Spent in Hypoglycemia (40 mg/dL - 54 mg/dL) | Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each) | All patients for whom continuous glucose monitoring data was available during the specified time periods | Posted | Mean | Standard Deviation | percentage of time | Weeks 1 through 6, Weeks 8 through 13 |
|
|
|
| Secondary | Percentage of Time Spent in Severe Hypoglycemia (> 40 mg/dL) | Percent of time spent is calculated as the accumulated time in hours spent within each range divided by the total number of hours spent under therapy with each drug (6 weeks each) | All patients for whom continuous glucose monitoring data was available during the specified time periods | Posted | Mean | Standard Deviation | percentage of time | Weeks 1 through 6, Weeks 8 through 13 |
|
|
|
| Secondary | 1,5 Anhydroglucitol Levels | 1,5 anhydroglucitol levels were measured on the 6th week of each therapy | All patients who participated in the meal test after 6 weeks of therapy in each period | Posted | Mean | Standard Deviation | µg/mL | Week 6, Week 13 |
|
|
|
|
| Secondary | Fructosamine Levels | Cumulative glycemic control expressed in fructosamine levels (micromol/Liter) were measured on the 6th week of each therapy | All patients who participated in the meal test after 6 weeks of therapy in each period | Posted | Mean | Standard Deviation | mcmol/L | Week 6, Week 13 |
|
|
|
|
| Secondary | HbA1c | Cumulative glycemic control expressed in HbA1c% measured on the 6th week of each therapy | All patients who participated in the meal test after 6 weeks of therapy in each period | Posted | Mean | Standard Deviation | HbA1c% | Week 6, Week 13 |
|
|
|
|
| Secondary | Insulin Use - Change in Daily Dose | Change was calculated as the value on the last day of therapy minus the value on the 1st day of therapy in each period | All patients who participated in the meal test after 6 weeks of therapy in each arm | Posted | Mean | Standard Deviation | units | Weeks 1 through 6, Weeks 8 through 13 |
|
|
|
| Secondary | Insulin Use - Bolus | Change in %bolus insulin (units) as the value on the last day of therapy minus the value on the 1st day of therapy in each period | All patients who participated in the meal test after 6 weeks of therapy in each arm | Posted | Mean | Standard Deviation | percentage of units | Weeks 1 through 6, Weeks 8 through 13 |
|
|
|
| Secondary | Insulin Use - Basal | Change in %basal insulin (units) as the value on the last day of therapy minus the value on the 1st day of therapy in each period | All patients who participated in the meal test after 6 weeks of therapy in each arm | Posted | Mean | Standard Deviation | percentage of units | Weeks 1 through 6, Weeks 8 through 13 |
|
|
|
| Secondary | Insulin Use - Automatic Basal Insulin | Average amount per day (units) calculated for each participant under each therapy | All patients who participated in the meal test after 6 weeks of therapy in each arm | Posted | Mean | Standard Deviation | units | Weeks 1 through 6, Weeks 8 through 13 |
|
|
|
| Secondary | Insulin Pump - Active Insulin Time | Average time per day (hours) calculated for each participant under each therapy | All patients who participated in the meal test after 6 weeks of therapy in each arm | Posted | Mean | Standard Deviation | hours | Weeks 1 through 6, Weeks 8 through 13 |
|
|
|
| Secondary | Insulin Pump - Auto Mode | Percentage of time spent in auto-mode after calibration under each therapy | All patients who participated in the meal test after 6 weeks of therapy in each arm | Posted | Mean | Standard Deviation | percentage of time | Weeks 3 through 6, Weeks 10 through 13 |
|
|
|
| Secondary | Insulin Pump - Manual Mode | Percentage of time spent in manual-mode after calibration under each therapy | All patients who participated in the meal test after 6 weeks of therapy in each arm | Posted | Mean | Standard Deviation | percentage of time | Weeks 3 through 6, Weeks 10 through 13 |
|
|
|
| Secondary | Change in Carbohydrate Ratio | Change was calculated as the carbohydrate ratio on the last day of therapy minus the carbohydrate ratio on the 1st day of therapy in each period | All patients who participated in the meal test after 6 weeks of therapy in each arm | Posted | Mean | Standard Deviation | I:CR | Weeks 1 through 6, Weeks 8 through 13 |
|
|
|
| Secondary | Infusion Site Reactions | Number of Infusion site reactions reported by patient | All patients who participated in the meal test after 6 weeks of therapy in each arm | Posted | Number | occurances | 14 week treatment period |
|
|
|
| Secondary | Pump Occlusions | Number of Occlusion events reported by patient | All patients who participated in the meal test after 6 weeks of therapy in each arm | Posted | Number | occurances | 14 week treatment period |
|
|
|
| 0 |
| 19 |
| 1 |
| 19 |
| 11 |
| 19 |
| EG001 | Novolog/Fiasp | 7 weeks on Novolog® then crossover to 7 weeks on Fiasp® in subjects on the 670g Hybrid Closed Loop Continuous Subcutaneous Insulin Infusion Fiasp®: Fiasp® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system Novolog®: Novolog® used in a 670G hybrid closed loop continuous subcutaneous insulin infusion system 670G hybrid closed loop continuous subcutaneous insulin infusion system: CSII | 0 | 18 | 0 | 18 | 7 | 18 |
|
| Worsening of Seasonal Allergic Rhinitis | General disorders | Systematic Assessment |
|
| Influenza | Infections and infestations | Systematic Assessment |
|
| Redness at infusion site (right abdomen) | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Trivial tricuspid regurgitation | Cardiac disorders | Systematic Assessment |
|
| Trivial mitral regurgitation | Cardiac disorders | Systematic Assessment |
|
| Viral infection | Infections and infestations | Systematic Assessment |
|
| Sore Throat | General disorders | Systematic Assessment |
|
| Headache | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Nasal Congestion | General disorders | Systematic Assessment |
|
| First Degree AV Block | Cardiac disorders | Systematic Assessment |
|
| Intermittent Heart Palpitations | Cardiac disorders | Systematic Assessment |
|
| Intermittent bradycardia | Cardiac disorders | Systematic Assessment |
|
| Worsening of Hypertension | Cardiac disorders | Systematic Assessment |
|
| Conjuntivitis | Infections and infestations | Systematic Assessment |
|
| Fever | General disorders | Systematic Assessment |
|
| Gasteroenteritis | Gastrointestinal disorders | Systematic Assessment |
|
| Supraventricular Tachycardia | Cardiac disorders | Systematic Assessment |
|
| Bronchitis | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Herniated Disc | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Abdominal Cramps | General disorders | Systematic Assessment |
|
| Emesis | General disorders | Systematic Assessment |
|
| Traveler's Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Hiatial Hernia | Gastrointestinal disorders | Systematic Assessment |
|
| Gastroesophageal reflux disease | Gastrointestinal disorders | Systematic Assessment |
|
| Irritation at Infusion site (abdoment) | Product Issues | Systematic Assessment | related to infusion site , not insulin |
|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
|
| Right Thumb laceration | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Common Cold | Infections and infestations | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Worsening of hypocalcemia | Endocrine disorders | Systematic Assessment |
|
| erythema at infusion site | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Sinus Infection | Infections and infestations | Systematic Assessment |
|
| Right index finger dislocation | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Triangular fibrocartilage band tear (left wrist) | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Worsening of hypothyroidsm | Endocrine disorders | Systematic Assessment |
|
| myalgia (bilateral shoulders0 | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Ecchymosis (bilateral hands) | General disorders | Systematic Assessment |
|
| acute kidney injury | Renal and urinary disorders | Systematic Assessment |
|
| Hyperkalemia | Cardiac disorders | Systematic Assessment |
|
| Center involved diabetic macular edema (right eye) | Eye disorders | Systematic Assessment |
|
| Vasovagal Syncope | General disorders | Systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |