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| Name | Class |
|---|---|
| Harvard University | OTHER |
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The aim of this clinical study is to determine the feasibility, safety, and preliminary effectiveness of the Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP) system in pediatric subjects with type 1 diabetes in an ambulatory semi-supervised environment over a short duration of 3 days and 2 nights, or up to 60 hours.
The artificial pancreas platform employed under study is centered about the following four key innovations: 1) A zone model predictive control strategy that is at the same time very safe with respect to hypoglycemia, and can simultaneously and independently be tuned with respect to its response to hyperglycemia; 2) Zone control with diurnal blood-glucose target zones; 3) Models of insulin-glucose physiology and insulin on board; 4) A system for alarming and notification of impending hypoglycemia and technical malfunctions: the Health Monitoring System. These features have been evaluated in several clinical trials in adults with unannounced meals and exercise.
The proposed study will evaluate enhancements to our previous system tailored for the special needs of pediatric subjects: 1) A control strategy with responses to hyperglycemia and hypoglycemia spanning wide ranges, as is typical with children; 2) The use of time-dependent zones specific for pediatric subjects; 3) The development of models for young children, capturing the greater physiologic variability, and ensuring cautious insulin delivery; 4) remote alarming and notification systems that are useful to parents.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP) | Experimental | Use Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP) system |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP) | Device | Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hypoglycemia Safety: Number of Participants With Blood Glucose (BG)) Readings < 50 Milligrams/Deciliter (mg/dL)) | Number of participants with more than one confirmed BG < 50 mg/dL | 60 hours |
| Hyperglycemia Safety: Number of Participants With More Than Two Blood Glucose (BG) Readings > 300 mg/dL Longer Than 2 Hour or Any BG 400 > Milligrams/Deciliter (mg/dL)) | No more than two confirmed BG ≥ 300 mg/dL longer than 2 hours, and no BG ≥ 400 mg/dL, unless determined to be from an infusion site failure. | 60 hours |
| Blood Ketone Safety: Number of Participants With Blood Ketone Levels > 1.0 mmol/l for Longer Than 2 Hours or Any Ketone Level> 3.0 mmol/l | Number of participants with blood ketone level > 1.0 mmol/l for longer than 2 hours, and no blood ketone level >3.0 mmol/L, unless determined to be from an infusion site. failure | 60 hours |
| Safety: Number of Participants Who Experienced an Adverse Event | Adverse events include seizure, loss of consciousness, severe hypoglycemia, diabetic ketoacidosis | 60 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Mean Meter and Sensor Glucose Levels Milligram/Deciliter (mg/dL) | Mean meter and sensor glucose levels (mg/dL) | 60 hours |
| Percent Sensor Glucose Time in Range (70-180 mg/dL) | Percentage of time, over the whole evaluation period, during which the glucose level, as determined by the continuous glucose sensor, is between 70-180 mg/dL |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06511 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35971681 | Derived | Deshpande S, Weinzimer SA, Gibbons K, Nally LM, Weyman K, Carria L, Zgorski M, Laffel LM, Doyle FJ 3rd, Dassau E. Feasibility and Preliminary Safety of Smartphone-Based Automated Insulin Delivery in Adolescents and Children With Type 1 Diabetes. J Diabetes Sci Technol. 2024 Mar;18(2):363-371. doi: 10.1177/19322968221116384. Epub 2022 Aug 16. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP) | Use Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP) system Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP): Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP) |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP) | Use Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP) system Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP): Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP) |
| 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 | Hypoglycemia Safety: Number of Participants With Blood Glucose (BG)) Readings < 50 Milligrams/Deciliter (mg/dL)) | Number of participants with more than one confirmed BG < 50 mg/dL | Posted | Count of Participants | Participants | 60 hours |
|
|
60 hours
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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 | Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP) | Use Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP) system Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP): Zone-Model Predictive Control Artificial Pancreas (ZMPC_AP) |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Stuart Weinzimer | Yale University | 203-785-5831 | stuart.weinzimer@yale.edu |
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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 | Nov 29, 2018 | Dec 17, 2021 | 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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SIngle arm cohort study
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| 60 hours |
| Percent Sensor Glucose Time Below Range (<70 mg/dL) | Percentage of time, over the whole evaluation period, during which the glucose level, as determined by the continuous glucose sensor, is below 70 mg/dL | 60 hours |
| Percent Sensor Glucose Time Above Range (>180 mg/dL) | Percentage of time, over the whole evaluation period, during which the glucose level, as determined by the continuous glucose sensor, is greater than 180 mg/dL | 60 hours |
| Percent Sensor Glucose Time in Hypoglycemia (<60 mg/dL) | Percentage of time, over the whole evaluation period, during which the glucose level, as determined by the continuous glucose sensor, is below 60 mg/dL | 60 hours |
| Percent Sensor Glucose Time in Hyperglycemia (>250 mg/dL) | Percentage of time, over the whole evaluation period, during which the glucose level, as determined by the continuous glucose sensor, is greater than 250 mg/dL | 60 hours |
| Percent Time AP System Active | Percentage of time, over the whole evaluation period, during which the sensor and pump are determined to be wirelessly connected and communicating with each other, based on duration of alert and error messages indicated by the system | 60 hours |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Duration of Type I Diabetes | Mean | Standard Deviation | years |
|
| Baseline A1c | Mean | Standard Deviation | percentage of HbA1c |
|
|
| Primary | Hyperglycemia Safety: Number of Participants With More Than Two Blood Glucose (BG) Readings > 300 mg/dL Longer Than 2 Hour or Any BG 400 > Milligrams/Deciliter (mg/dL)) | No more than two confirmed BG ≥ 300 mg/dL longer than 2 hours, and no BG ≥ 400 mg/dL, unless determined to be from an infusion site failure. | Posted | Count of Participants | Participants | 60 hours |
|
|
|
| Primary | Blood Ketone Safety: Number of Participants With Blood Ketone Levels > 1.0 mmol/l for Longer Than 2 Hours or Any Ketone Level> 3.0 mmol/l | Number of participants with blood ketone level > 1.0 mmol/l for longer than 2 hours, and no blood ketone level >3.0 mmol/L, unless determined to be from an infusion site. failure | Posted | Count of Participants | Participants | 60 hours |
|
|
|
| Primary | Safety: Number of Participants Who Experienced an Adverse Event | Adverse events include seizure, loss of consciousness, severe hypoglycemia, diabetic ketoacidosis | Posted | Count of Participants | Participants | 60 hours |
|
|
|
| Secondary | Mean Meter and Sensor Glucose Levels Milligram/Deciliter (mg/dL) | Mean meter and sensor glucose levels (mg/dL) | Posted | Mean | Standard Deviation | mg/dL | 60 hours |
|
|
|
| Secondary | Percent Sensor Glucose Time in Range (70-180 mg/dL) | Percentage of time, over the whole evaluation period, during which the glucose level, as determined by the continuous glucose sensor, is between 70-180 mg/dL | Posted | Mean | Standard Deviation | percentage of time | 60 hours |
|
|
|
| Secondary | Percent Sensor Glucose Time Below Range (<70 mg/dL) | Percentage of time, over the whole evaluation period, during which the glucose level, as determined by the continuous glucose sensor, is below 70 mg/dL | Posted | Mean | Standard Deviation | percentage of time | 60 hours |
|
|
|
| Secondary | Percent Sensor Glucose Time Above Range (>180 mg/dL) | Percentage of time, over the whole evaluation period, during which the glucose level, as determined by the continuous glucose sensor, is greater than 180 mg/dL | Posted | Mean | Standard Deviation | percentage of time | 60 hours |
|
|
|
| Secondary | Percent Sensor Glucose Time in Hypoglycemia (<60 mg/dL) | Percentage of time, over the whole evaluation period, during which the glucose level, as determined by the continuous glucose sensor, is below 60 mg/dL | Posted | Mean | Standard Deviation | percentage of time | 60 hours |
|
|
|
| Secondary | Percent Sensor Glucose Time in Hyperglycemia (>250 mg/dL) | Percentage of time, over the whole evaluation period, during which the glucose level, as determined by the continuous glucose sensor, is greater than 250 mg/dL | Posted | Mean | Standard Deviation | percentage of time | 60 hours |
|
|
|
| Secondary | Percent Time AP System Active | Percentage of time, over the whole evaluation period, during which the sensor and pump are determined to be wirelessly connected and communicating with each other, based on duration of alert and error messages indicated by the system | Posted | Mean | Standard Deviation | percentage of time | 60 hours |
|
|
|
| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| diabetic ketoacidosis |
|
| no adverse event |
|