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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK085591 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The purpose of this study is to evaluate an overnight system that will turn off the insulin pump automatically if the system predicts that a low blood sugar is likely. The study system includes a combination continuous glucose monitor (CGM)/ insulin pump made by Medtronic MiniMed, Inc and a regular laptop computer that runs a computer program that predicts low blood sugar. It works by (1) measuring the glucose levels under the skin with a continuous glucose monitor, (2) using a computer program on a laptop to predict what will happen to the glucose level over the next 35-55 minutes, and (3) turning off the insulin pump when the computer program predicts that low blood sugar will occur. We have tested this system overnight in the hospital and are ready to test the system in the home environment to learn more about how well it will work and to make sure that the blood sugar does not go too high when the pump shuts off.
This study has several phases and will take about a month or a little more for a patient to complete. Patients will use the study system for about 5 days at home to show that the patient is able to use it correctly. After that, the patient will be asked to use the study system each night for an additional 3-4 weeks. During this time, the system will be active for two-thirds of the nights and not active for one-third of the nights. When the system is active and predicts that your blood sugar will become low, the insulin pump will shut off for up to 2 hours.
The study will include 2 clinical centers in the United States.
Patients who meet all eligibility criteria will use the study system overnight at home for about 5 nights to demonstrate their ability to use the system and submit study data to the Coordinating Center.
Patients who successfully demonstrate their ability to use the system as described above will be eligible for the randomized trial phase. This phase consists of use of the full system as an outpatient for approximately 21 nights:
Upon completion of the study, patients as well as study clinicians will be asked to complete a questionnaire regarding use of the study system.
There will a follow-up visit after completion of 21 successful nights of study system use. A successful night of study system use is defined as use of the system for at least four hours. Phone contacts with the patients will be made once a week.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Predictive pump suspension algorithm | Active Comparator | The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. |
|
| Standard of Care | No Intervention | The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pump suspension | Device | The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend. |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Morning Blood Glucose (mg/dL)- Algorithm 1 | The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as mean morning blood glucose (mg/dL). An objective was to evaluate and refine the control algorithm. The data were reviewed periodically during the study with the pre-stated goal of determining whether any changes should be made in the control algorithm. Algorithm 1 was used for the first 105 nights of the study (38 Control nights and 67 Intervention nights). The horizon prediction time of algorithm 1 was set at 70 minutes. | 21 study nights |
| Mean Morning Blood Glucose (mg/dL)- Algorithm 2 | The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as mean morning blood glucose (mg/dL). Algorithm 1 was modified to reduce the hypoglycemia prediction horizon from 70 minutes to 50 minutes, to suspend the pump only when the continuous glucose monitor sensor glucose value was ≤ 230 mg/dl, not suspend if there was a drop of >40 mg/dl in consecutive sensor glucose readings, and to resume insulin delivery at the first rise in sensor glucose following a suspension. There was 156 nights of study data collected (48 Control nights and 108 Intervention nights) using algorithm 2. | 21 study nights |
| Mean Morning Blood Glucose (mg/dL)- Algorithm 3 | The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as mean morning blood glucose (mg/dL). The hypoglycemia prediction horizon was reduced further in algorithm 3 to 30 minutes. A total of 114 study nights (37 Control nights and 77 Intervention nights) using algorithm 3. | 21 study nights |
| Percent Morning Blood Glucose >250 mg/dL - Algorithm 1 |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Sensor Glucose Overnight - Algorithm 1 | Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use | |
| Mean Sensor Glucose Overnight - Algorithm 2 | Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bruce A Buckingham, MD | Stanford University | Study Chair |
| Roy W Beck, MD, PhD | Jaeb Center for Health Research | Principal Investigator |
| John Lum, MS | Jaeb Center for Health Research | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States | ||
| Barbara Davis Center for Childhood Diabetes |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23883408 | Result | Buckingham BA, Cameron F, Calhoun P, Maahs DM, Wilson DM, Chase HP, Bequette BW, Lum J, Sibayan J, Beck RW, Kollman C. Outpatient safety assessment of an in-home predictive low-glucose suspend system with type 1 diabetes subjects at elevated risk of nocturnal hypoglycemia. Diabetes Technol Ther. 2013 Aug;15(8):622-7. doi: 10.1089/dia.2013.0040. Epub 2013 Jul 24. |
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After the run-in phase, a 21-night randomized trial was conducted in which each night was randomly assigned 2:1 to have either the predictive low glucose suspend system active (intervention) or inactive (control). Participants were current users of the MiniMed Paradigm® REAL-Time Revel™ System and Sof-sensor® glucose sensor at time of enrollment.
The study was conducted at Stanford University and the Barbara Davis Center. A total of 20 subjects were enrolled between January 1, 2012 and June 30, 2012. Nineteen participants 18-56 years old with type 1 diabetes (HbA1c 6.0%-7.7%) completed the trial.
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| ID | Title | Description |
|---|---|---|
| FG000 | Randomized Nights- Treatment or Control | Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Each night randomized to have either Predictive Low Glucose suspend or inactive (control).
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| ID | Title | Description |
|---|---|---|
| BG000 | Randomized Nights- Treatment or Control | Each study night will be randomized to have either Predictive Low Glucose Suspend or to be inactive (control). On nights randomized to the intervention treatment, the study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. (Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend.) On control nights, the algorithm will run passively and not recommend suspensions or resumption to the patient's pump. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of 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 | Mean Morning Blood Glucose (mg/dL)- Algorithm 1 | The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as mean morning blood glucose (mg/dL). An objective was to evaluate and refine the control algorithm. The data were reviewed periodically during the study with the pre-stated goal of determining whether any changes should be made in the control algorithm. Algorithm 1 was used for the first 105 nights of the study (38 Control nights and 67 Intervention nights). The horizon prediction time of algorithm 1 was set at 70 minutes. | Posted | Mean | Standard Deviation | mg/dl | 21 study nights | Number of Mornings Analyzed | Participants |
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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 | Predictive Pump Suspension Algorithm | The study laptop will be running actively during the night and suspending the patient's pump if the algorithm predicts hypoglycemia based on the patient's continuous glucose sensor trend. Pump suspension : The study laptop will communicate to the pump causing suspension based on output from the algorithm which predicts hypoglycemia based on the continuous glucose sensor trend. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Roy W. Beck, MD, PhD | Jaeb Center for Health Resesarch | 813-975-8690 | jdrfapp2@jaeb.org |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D007003 | Hypoglycemia |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as the overall percentage of mornings glucose measured with home glucose meter >250 mg/dL.
| 21 days |
| Percent Morning Blood Glucose >250 mg/dL - Algorithm 2 | The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as overall percentage of mornings glucose measured with home glucose meter >250 mg/dL. | 21 days |
| Percent Morning Blood Glucose >250 mg/dL - Algorithm 3 | The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as overall percentage of mornings glucose measured with home glucose meter >250 mg/dL. | 21 days |
| Mornings With Blood Ketones >0.6 mmol/L - Algorithm 1 | The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with blood ketones >0.6 mmol/L. | 21 days |
| Mornings With Blood Ketones >0.6 mmol/L - Algorithm 2 | The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with blood ketones >0.6 mmol/L. | 21 days |
| Mornings With Blood Ketones >0.6 mmol/L - Algorithm 3 | The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with blood ketones >0.6 mmol/L. | 21 days |
| Mornings With Urine Ketones Characterized as Moderate or Large - Algorithm 1 | The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with urine ketones characterized as moderate or large based on measurement results of a urine dipstick test taken using Ketostix. Moderate is considered approximately 30 - 40 mg/dL and Large >80 mg/dL. | 21 days |
| Mornings With Urine Ketones Characterized as Moderate or Large - Algorithm 2 | The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with urine ketones characterized as moderate or large based on measurement results of a urine dipstick test taken using Ketostix. Moderate is considered approximately 30 - 40 mg/dL and Large >80 mg/dL. | 21 days |
| Mornings With Urine Ketones Characterized as Moderate or Large - Algorithm 3 | The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with urine ketones characterized as moderate or large based on measurement results of a urine dipstick test taken using Ketostix. Moderate is considered approximately 30 - 40 mg/dL and Large >80 mg/dL. | 21 days |
| Mean Sensor Glucose Overnight - Algorithm 3 | Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use |
| Percentage of Sensor Glucose Values 71 to 180 mg/dL - Algorithm 1 | Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use |
| Percentage of Sensor Glucose Values 71 to 180 mg/dL - Algorithm 2 | Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use |
| Percentage of Sensor Glucose Values 71 to 180 mg/dL - Algorithm 3 | Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use |
| Aurora |
| Colorado |
| 80045 |
| United States |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| OG001 | Standard of Care | The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump. |
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| Primary | Mean Morning Blood Glucose (mg/dL)- Algorithm 2 | The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as mean morning blood glucose (mg/dL). Algorithm 1 was modified to reduce the hypoglycemia prediction horizon from 70 minutes to 50 minutes, to suspend the pump only when the continuous glucose monitor sensor glucose value was ≤ 230 mg/dl, not suspend if there was a drop of >40 mg/dl in consecutive sensor glucose readings, and to resume insulin delivery at the first rise in sensor glucose following a suspension. There was 156 nights of study data collected (48 Control nights and 108 Intervention nights) using algorithm 2. | Posted | Mean | Standard Deviation | mg/dl | 21 study nights | Number of Mornings Analyzed | Participants |
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| Primary | Mean Morning Blood Glucose (mg/dL)- Algorithm 3 | The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as mean morning blood glucose (mg/dL). The hypoglycemia prediction horizon was reduced further in algorithm 3 to 30 minutes. A total of 114 study nights (37 Control nights and 77 Intervention nights) using algorithm 3. | Posted | Mean | Standard Deviation | mg/dl | 21 study nights | Number of Mornings Analyzed | Participants |
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| Primary | Percent Morning Blood Glucose >250 mg/dL - Algorithm 1 | The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as the overall percentage of mornings glucose measured with home glucose meter >250 mg/dL. | Posted | Number | percentage of mornings | 21 days | Number of Mornings Analyzed | Participants |
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| Secondary | Mean Sensor Glucose Overnight - Algorithm 1 | Posted | Mean | Standard Deviation | mg/dl | Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use | Number of Nights Analyzed | Participants |
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| Secondary | Mean Sensor Glucose Overnight - Algorithm 2 | Posted | Mean | Standard Deviation | mg/dl | Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use | Number of Nights Analyzed | Participants |
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| Secondary | Mean Sensor Glucose Overnight - Algorithm 3 | Posted | Mean | Standard Deviation | mg/dl | Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use | Number of Nights Analyzed | Participants |
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| Secondary | Percentage of Sensor Glucose Values 71 to 180 mg/dL - Algorithm 1 | Posted | Median | Inter-Quartile Range | percentage of sensor glucose values | Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use | Number of Nights Analyzed | Participants |
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| Secondary | Percentage of Sensor Glucose Values 71 to 180 mg/dL - Algorithm 2 | Posted | Median | Inter-Quartile Range | percentage of sensor glucose values | Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use | Number of Nights Analyzed | Participants |
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| Secondary | Percentage of Sensor Glucose Values 71 to 180 mg/dL - Algorithm 3 | Posted | Median | Inter-Quartile Range | percentage of sensor glucose values | Overnight from system activation to deactivation in the morning upon awakening for 21 nights of system use | Number of Nights Analyzed | Participants |
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| Primary | Percent Morning Blood Glucose >250 mg/dL - Algorithm 2 | The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as overall percentage of mornings glucose measured with home glucose meter >250 mg/dL. | Posted | Number | percentage of mornings | 21 days | Number of Mornings Analyzed | Participants |
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| Primary | Percent Morning Blood Glucose >250 mg/dL - Algorithm 3 | The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as overall percentage of mornings glucose measured with home glucose meter >250 mg/dL. | Posted | Number | percentage of mornings | 21 days | Number of Mornings Analyzed | Participants |
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| Primary | Mornings With Blood Ketones >0.6 mmol/L - Algorithm 1 | The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with blood ketones >0.6 mmol/L. | Posted | Number | number of mornings | 21 days | Number of Mornings Analyzed | Participants |
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| Primary | Mornings With Blood Ketones >0.6 mmol/L - Algorithm 2 | The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with blood ketones >0.6 mmol/L. | Posted | Number | number of mornings | 21 days | Number of Mornings Analyzed | Participants |
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| Primary | Mornings With Blood Ketones >0.6 mmol/L - Algorithm 3 | The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with blood ketones >0.6 mmol/L. | Posted | Number | number of mornings | 21 days | Number of Mornings Analyzed | Participants |
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| Primary | Mornings With Urine Ketones Characterized as Moderate or Large - Algorithm 1 | The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with urine ketones characterized as moderate or large based on measurement results of a urine dipstick test taken using Ketostix. Moderate is considered approximately 30 - 40 mg/dL and Large >80 mg/dL. | Posted | Number | number of mornings | 21 days | Number of Mornings Analyzed | Participants |
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| Primary | Mornings With Urine Ketones Characterized as Moderate or Large - Algorithm 2 | The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with urine ketones characterized as moderate or large based on measurement results of a urine dipstick test taken using Ketostix. Moderate is considered approximately 30 - 40 mg/dL and Large >80 mg/dL. | Posted | Number | number of mornings | 21 days | Number of Mornings Analyzed | Participants |
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| Primary | Mornings With Urine Ketones Characterized as Moderate or Large - Algorithm 3 | The primary safety outcome will be evaluated by comparing the intervention and control nights and nights with vs. without actual shut-off of the pump for several measures of hyperglycemia such as number of mornings with urine ketones characterized as moderate or large based on measurement results of a urine dipstick test taken using Ketostix. Moderate is considered approximately 30 - 40 mg/dL and Large >80 mg/dL. | Posted | Number | number of mornings | 21 days | Number of Mornings Analyzed | Participants |
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| 0 |
| 20 |
| 0 |
| 20 |
| EG001 | Standard of Care | The control algorithm will run passively and not recommend suspensions or resumption to the patient's pump. | 0 | 20 | 0 | 20 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |