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| ID | Type | Description | Link |
|---|---|---|---|
| UC4DK108483 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Harvard University | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Jaeb Center for Health Research | OTHER |
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The investigators aim to compare the efficacy and safety of an AID system using an adaptive MPC algorithm versus SAP (which may or may not include PLGS; to be referred to as SAP) in people with type 1 diabetes.
A randomized crossover trial will compare the efficacy and safety of an automated insulin delivery (AID) study system using an adaptive Model Predictive Control (MPC) algorithm versus SAP (which may or may not include PLGS; to be referred to as SAP) therapy in people with type 1 diabetes for 13 weeks in each arm of the study. A Pilot Phase using the study system for 10-14 days will be conducted prior to the crossover trial.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Artificial Pancreas | Experimental | Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes. |
|
| Sensor Augmented Pump/Predictive Low Glucose Suspend | Active Comparator | Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| interoperable Artificial Pancreas System (iAPS) | Device | Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS. |
| Measure | Description | Time Frame |
|---|---|---|
| Percent CGM Time in Range 70-180 mg/dL | This results shown is mean percent time in range 70-180 mg/dL. | 13 weeks |
| Non-inferiority for CGM Time <54 mg/dL | Superiority for time in range 70-180 mg/dL and non-inferiority for time <54 mg/dL measured with CGM will be considered primary endpoints, analyzed using a hierarchical gatekeeping testing procedure | 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| CGM Mean Glucose | CGM-measured mean glucose (mg/dL) | 13 weeks |
| CGM Time > 180 | CGM time > 180 mg/dL | 13 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| CGM Metrics by Time of Day | Calculate all CGM metrics listed above (including the primary outcome) for: All 24 hours of the day, Daytime only (06:00AM to 00:00AM), Nighttime only (00:00AM to 06:00AM). | 13 weeks |
| Number of Participants With Severe Hypoglycemia (Per Protocol) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eyal Dassau, PhD | Harvard University | Study Chair |
| Jordan Pinsker, MD | Sansum Diabetes Research Institute | Study Chair |
| Francis J Doyle III, PhD | Harvard University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sansum Diabetes Research Institute | Santa Barbara | California | 93105 | United States | ||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35549708 | Result | Pinsker JE, Dassau E, Deshpande S, Raghinaru D, Buckingham BA, Kudva YC, Laffel LM, Levy CJ, Church MM, Desrochers H, Ekhlaspour L, Kaur RJ, Levister C, Shi D, Lum JW, Kollman C, Doyle FJ; iDCL Trial Research Group. Outpatient Randomized Crossover Comparison of Zone Model Predictive Control Automated Insulin Delivery with Weekly Data Driven Adaptation Versus Sensor-Augmented Pump: Results from the International Diabetes Closed-Loop Trial 4. Diabetes Technol Ther. 2022 Sep;24(9):635-642. doi: 10.1089/dia.2022.0084. Epub 2022 Jun 2. |
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NIH's Data Sharing Policy on sharing research resources for research purposes to the scientific community will be followed. Data will be stored in a Data Archive Database includes CGM-insulin delivery time series & boluses, will be deidentified & retrievable only by subject ID number. Individual patterns of demographic & insulin treatment parameters leave open a remote possibility of deductive disclosure of subjects with unusual characteristics. Thus, data will be made available only under a Data-Sharing Agreement that includes: (1) a commitment to using the data only for research purposes & not to identify participants; (2) a commitment to securing the data using appropriate computer technology; & (3) a commitment to destroying or returning the data after analyses are completed.
The dataset from each iDCL protocol will be made public after publication of all manuscripts written by the study group using the dataset and any regulatory submission/completion of review by the regulatory agency, but no later than 3 years after the completion of the protocol even if additional manuscripts or regulatory submissions are planned.
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| ID | Title | Description |
|---|---|---|
| FG000 | Artificial Pancreas First, Then Sensor-Augmented Pump/Predicitive Low Glucose Suspend | Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes. interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS. Subjects will then continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor. Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM & glucometer at home for 13 weeks. |
| FG001 | Sensor Augmented Pump/Predictive Low Glucose Suspend First, Then Artificial Pancreas | Subjects will then continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor. Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM & glucometer at home for 13 weeks. Then subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes. interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Artificial Pancreas First, Then Sensor-Augmented Pump/Predictive Low Glucose Suspend | Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes. interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS. After 13 weeks, participants then crossed over to the other arm. |
| 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 | Percent CGM Time in Range 70-180 mg/dL | This results shown is mean percent time in range 70-180 mg/dL. | Posted | Mean | Standard Deviation | percentage of time | 13 weeks |
|
From protocol entry through last study date which is approximately 26-28 weeks per participant.
Definitions are the same as the clinicaltrials.gov definition. Please see clinical protocol for exclusions to adverse event collection.
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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 | Artificial Pancreas | Subjects will be provided the Interoperable Artificial Pancreas System (iAPS) which includes the iAPS phone platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This iAPS is designed to help control blood sugar in people living with type 1 diabetes. interoperable Artificial Pancreas System (iAPS): Use of the iAPS at home for 13 weeks, with weekly adaptation of insulin delivery settings occurring automatically in the iAPS. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe Hypoglycemia | Endocrine disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycemia or ketosis events without meeting criteria for Diabetic Ketoacidosis | Endocrine disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jordan Pinsker | Sansum Diabetes Research Institute | 805-682-7640 | jpinsker@sansum.org |
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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 | Dec 14, 2020 | Dec 18, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 1, 2020 | Dec 18, 2021 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 31, 2020 | Dec 27, 2021 | ICF_002.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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| Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS) | Other | Use of personal pump with study CGM & glucometer at home for 13 weeks. |
|
| CGM Time > 250 | CGM time > 250 mg/dL | 13 weeks |
| CGM Time < 70 | CGM time < 70 mg/dL | 13 weeks |
| CGM Time < 54 (Superiority) | CGM time < 54 mg/dL (Superiority) | 13 weeks |
| Coefficient of Variation | CGM measured glucose variability measured with the coefficient of variation (CV) | 13 weeks |
| CGM Time in Range 70-140 mg/dL | CGM-measured % in range 70-140 mg/dL | 13 weeks |
| Standard Deviation | CGM measured glucose variability measured with the standard deviation (SD) | 13 weeks |
| CGM Time < 60 | CGM time < 60 mg/dL | 13 weeks |
| LBGI | Low blood glucose index (LBGI) by CGM with higher index indicating higher risk of hypoglycemia. LBGI ≤ 1.1 is associated with minimal risk of hypoglycemia, 1.1 < LBGI ≤ 2.5 is associated with a low risk of hypoglycemia, 2.5 < LBGI ≤ 5.0 is associated with a moderate risk of hypoglycemia, and LBGI > 5.0 is associated with high risk of hypoglycemia. | 13 weeks |
| CGM Time > 300 | CGM time > 300 mg/dL | 13 weeks |
| HBGI | High Blood Glucose Index (HBGI) is a measure of Hyperglycemic Risk based on frequency and severity of hyperglycemic events. HBGI < 4.5 is associated with lower risk of hyperglycemia, 4.5 < HBGI < 9 is associated with a moderate risk of hyperglycemia and HBGI > 9 is associated with high risk of hyperglycemia | 13 weeks |
| HbA1c at 13 Weeks | Hemiglobin A1c measured after completing each study arm | 13 weeks |
| Number of Participants With HbA1c <7.0% at 13 Weeks | Number of participants HbA1c <7.0% after completing each study arm | 13 weeks |
| Number of Participants With HbA1c <7.5% at 13 Weeks | Number of participants HbA1c <7.5% after completing each study arm | 3 months |
| Diabetes Distress Scale at 13 Weeks - Total Score | Diabetes Distress Scale for adults has 28 items rated on a 6 point Likert scale that ranges from 1 (not a problem) to 6 (a very serious problem). The total score is the mean of the sum of responses and ranges from 1 to 6 where a higher score indicates greater degrees of diabetes distress. | 13 weeks |
| Glucose Monitoring Satisfaction Survey (Total Scale) | The GMSS for Type 1 Diabetes contains four subscales as well as a total scale. For this measure, total scale is reported. To calculate the total scale (higher scores indicate greater satisfaction): Mean of all items 1-15 (reverse code items: 2-7, 9, 11-13, and 15) which are all scored on a 5 point scale (1-5) (Minimum Total Scale Score is 1, Maximum Total Scale Score is 5) | 13 weeks |
| Hypoglycemia Confidence Scale | Hypoglycemia Confidence Scale has 20 items which are rated on a 4-point Likert Scale ranging from 1 (not confident at all) to 4 (very confident) with higher scores indicating higher confidence in dealing with hypoglycemia. A single score is computed by calculating the mean of the sum of all items and ranges from 1 to 4. | 13 weeks |
| INSPIRE Survey Scores - Following Study System Period Only | The INSPIRE questionnaire assesses user expectations and experiences with Insulin Delivery Systems: Perceptions, Ideas, Reflections, Expectations (INSPIRE). Survey total scores are computed by calculating the mean of the sum of all item ratings then multiplying the mean by 25 to scale the score to a range from 0 to 100. Higher scores indicate a more positive perception of insulin delivery systems. Items are rated on a 5 point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). The Adult survey has 22 items, the Teens/Adolescents survey has 17 items and the Parent survey has 21 items. | 13 weeks |
| SUS Survey Scores - Following Study System Period | System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicate better perceived usability | 13 weeks |
| Total Daily Insulin | Total Daily Insulin (units) | 13 weeks |
| Basal: Bolus Insulin Ratio | Basal: bolus insulin ratio | 13 weeks |
Severe hypoglycemia (per protocol) |
| 13 weeks |
| Number of Participants With Diabetic Ketoacidosis (Per Protocol) | Diabetic ketoacidosis (per protocol) | 13 weeks |
| Ketone Events Defined as Day With Ketone Level >1.0 mmol/L | Ketone events defined as day with ketone level >1.0 mmol/L | 13 weeks |
| CGM-measured Hypoglycemic Events (>15 Minutes With Glucose Concentration <54 mg/dL) | CGM-measured hypoglycemic events (>15 minutes with glucose concentration <54 mg/dL) in each arm. | 3 months |
| CGM-measured Hyperglycemic Events (>15 Minutes With Glucose Concentration >300 mg/dL) | CGM-measured hyperglycemic events (>15 minutes with glucose concentration >300 mg/dL) in each arm. | 3 months |
| BG-measured Hypoglycemic Events (One BG Record <54 mg/dL | BG-measured Hypoglycemic Events (One BG Record <54 mg/dL | 13 weeks |
| Worsening of HbA1c From Baseline to 26 Weeks by >0.5% | Worsening of HbA1c from baseline to 26 weeks by >0.5% | 13 weeks |
| Other Serious Adverse Events (SAE) and Serious Adverse Device Events (SADE) | Other serious adverse events (SAE) and serious adverse device events (SADE) | 13 weeks |
| Adverse Device Effects (ADE) | Adverse device effects (ADE) | 13 weeks |
| Unanticipated Adverse Device Effects (UADE) | Unanticipated adverse device effects (UADE) | 13 weeks |
| Number of Participants With SH Events | For this outcome, mean +/- SD or summary statistics appropriate to the distribution will be tabulated by treatment group | 13 weeks |
| SH Event Rate Per 100 Person-years | For this outcome, severe hypoglycemia event rate per 100 person-years will be calculated as a rate. | 13 weeks |
| Number of Participants With DKA Events | For this outcome, number of participants with diabetic ketoacidosis (DKA) will be tabulated. | 13 weeks |
| DKA Event Rate Per 100 Person-years | For this outcome, the diabetic ketoacidosis event rate per 100 person-years will be calculated as a rate. | 13 weeks |
| Any Adverse Event Rate Per 100 Person-years | For this outcome, the adverse event rate per 100 person-years calculated as a rate. | 13 weeks |
| Stanford |
| California |
| 94304 |
| United States |
| Joslin Diabetes Center | Boston | Massachusetts | 02215 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | United States |
| BG001 | Sensor Augmented Pump/Predictive Low Glucose Suspend First, Then Artificial Pancreas | Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor. Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM & glucometer at home for 13 weeks. After 13 weeks, participants then crossed over to the other arm. |
| 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 |
|
Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor.
Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM & glucometer at home for 13 weeks.
|
|
| Primary | Non-inferiority for CGM Time <54 mg/dL | Superiority for time in range 70-180 mg/dL and non-inferiority for time <54 mg/dL measured with CGM will be considered primary endpoints, analyzed using a hierarchical gatekeeping testing procedure | Posted | Mean | Standard Deviation | percentage of time | 13 weeks |
|
|
|
| Secondary | CGM Mean Glucose | CGM-measured mean glucose (mg/dL) | Posted | Mean | Standard Deviation | mg/dL | 13 weeks |
|
|
|
| Secondary | CGM Time > 180 | CGM time > 180 mg/dL | Posted | Mean | Standard Deviation | percentage of time | 13 weeks |
|
|
|
| Secondary | CGM Time > 250 | CGM time > 250 mg/dL | Posted | Mean | Standard Deviation | percentage of time | 13 weeks |
|
|
|
| Secondary | CGM Time < 70 | CGM time < 70 mg/dL | Posted | Mean | Standard Deviation | percentage of time | 13 weeks |
|
|
|
| Secondary | CGM Time < 54 (Superiority) | CGM time < 54 mg/dL (Superiority) | Posted | Mean | Standard Deviation | percentage of time | 13 weeks |
|
|
|
| Secondary | Coefficient of Variation | CGM measured glucose variability measured with the coefficient of variation (CV) | Posted | Mean | Standard Deviation | percentage SD of Mean | 13 weeks |
|
|
|
| Secondary | CGM Time in Range 70-140 mg/dL | CGM-measured % in range 70-140 mg/dL | Posted | Mean | Standard Deviation | percentage of time | 13 weeks |
|
|
|
| Secondary | Standard Deviation | CGM measured glucose variability measured with the standard deviation (SD) | Posted | Mean | Standard Deviation | mg/dL | 13 weeks |
|
|
|
| Secondary | CGM Time < 60 | CGM time < 60 mg/dL | Posted | Mean | Standard Deviation | percentage of time | 13 weeks |
|
|
|
| Secondary | LBGI | Low blood glucose index (LBGI) by CGM with higher index indicating higher risk of hypoglycemia. LBGI ≤ 1.1 is associated with minimal risk of hypoglycemia, 1.1 < LBGI ≤ 2.5 is associated with a low risk of hypoglycemia, 2.5 < LBGI ≤ 5.0 is associated with a moderate risk of hypoglycemia, and LBGI > 5.0 is associated with high risk of hypoglycemia. | Posted | Mean | Standard Deviation | index score | 13 weeks |
|
|
|
| Secondary | CGM Time > 300 | CGM time > 300 mg/dL | Posted | Mean | Standard Deviation | percentage of time | 13 weeks |
|
|
|
| Secondary | HBGI | High Blood Glucose Index (HBGI) is a measure of Hyperglycemic Risk based on frequency and severity of hyperglycemic events. HBGI < 4.5 is associated with lower risk of hyperglycemia, 4.5 < HBGI < 9 is associated with a moderate risk of hyperglycemia and HBGI > 9 is associated with high risk of hyperglycemia | Posted | Mean | Standard Deviation | index score | 13 weeks |
|
|
|
| Secondary | HbA1c at 13 Weeks | Hemiglobin A1c measured after completing each study arm | Posted | Mean | Standard Deviation | percentage of glycated hemoglobin | 13 weeks |
|
|
|
| Secondary | Number of Participants With HbA1c <7.0% at 13 Weeks | Number of participants HbA1c <7.0% after completing each study arm | Posted | Count of Participants | Participants | 13 weeks |
|
|
|
| Secondary | Number of Participants With HbA1c <7.5% at 13 Weeks | Number of participants HbA1c <7.5% after completing each study arm | Posted | Count of Participants | Participants | 3 months |
|
|
|
| Secondary | Diabetes Distress Scale at 13 Weeks - Total Score | Diabetes Distress Scale for adults has 28 items rated on a 6 point Likert scale that ranges from 1 (not a problem) to 6 (a very serious problem). The total score is the mean of the sum of responses and ranges from 1 to 6 where a higher score indicates greater degrees of diabetes distress. | Posted | Mean | Standard Deviation | score on a scale | 13 weeks |
|
|
|
| Secondary | Glucose Monitoring Satisfaction Survey (Total Scale) | The GMSS for Type 1 Diabetes contains four subscales as well as a total scale. For this measure, total scale is reported. To calculate the total scale (higher scores indicate greater satisfaction): Mean of all items 1-15 (reverse code items: 2-7, 9, 11-13, and 15) which are all scored on a 5 point scale (1-5) (Minimum Total Scale Score is 1, Maximum Total Scale Score is 5) | Posted | Mean | Standard Deviation | score on a scale | 13 weeks |
|
|
|
| Secondary | Hypoglycemia Confidence Scale | Hypoglycemia Confidence Scale has 20 items which are rated on a 4-point Likert Scale ranging from 1 (not confident at all) to 4 (very confident) with higher scores indicating higher confidence in dealing with hypoglycemia. A single score is computed by calculating the mean of the sum of all items and ranges from 1 to 4. | Posted | Mean | Standard Deviation | score on a scale | 13 weeks |
|
|
|
| Secondary | INSPIRE Survey Scores - Following Study System Period Only | The INSPIRE questionnaire assesses user expectations and experiences with Insulin Delivery Systems: Perceptions, Ideas, Reflections, Expectations (INSPIRE). Survey total scores are computed by calculating the mean of the sum of all item ratings then multiplying the mean by 25 to scale the score to a range from 0 to 100. Higher scores indicate a more positive perception of insulin delivery systems. Items are rated on a 5 point Likert scale ranging from 0 (strongly disagree) to 4 (strongly agree). The Adult survey has 22 items, the Teens/Adolescents survey has 17 items and the Parent survey has 21 items. | following study system period only | Posted | Mean | Standard Deviation | score on a scale | 13 weeks |
|
|
|
| Secondary | SUS Survey Scores - Following Study System Period | System Usability Scores (SUS)-composite score from 0 to 100 with higher scores indicate better perceived usability | following study system period | Posted | Mean | Standard Deviation | score on a scale | 13 weeks |
|
|
|
| Secondary | Total Daily Insulin | Total Daily Insulin (units) | Posted | Median | Inter-Quartile Range | units/kg | 13 weeks |
|
|
|
| Secondary | Basal: Bolus Insulin Ratio | Basal: bolus insulin ratio | Posted | Median | Inter-Quartile Range | ratio | 13 weeks |
|
|
|
| Other Pre-specified | CGM Metrics by Time of Day | Calculate all CGM metrics listed above (including the primary outcome) for: All 24 hours of the day, Daytime only (06:00AM to 00:00AM), Nighttime only (00:00AM to 06:00AM). | Not Posted | 13 weeks | Participants |
| Other Pre-specified | Number of Participants With Severe Hypoglycemia (Per Protocol) | Severe hypoglycemia (per protocol) | Not Posted | 13 weeks | Participants |
| Other Pre-specified | Number of Participants With Diabetic Ketoacidosis (Per Protocol) | Diabetic ketoacidosis (per protocol) | Not Posted | 13 weeks | Participants |
| Other Pre-specified | Ketone Events Defined as Day With Ketone Level >1.0 mmol/L | Ketone events defined as day with ketone level >1.0 mmol/L | Not Posted | 13 weeks | Participants |
| Other Pre-specified | CGM-measured Hypoglycemic Events (>15 Minutes With Glucose Concentration <54 mg/dL) | CGM-measured hypoglycemic events (>15 minutes with glucose concentration <54 mg/dL) in each arm. | Not Posted | 3 months | Participants |
| Other Pre-specified | CGM-measured Hyperglycemic Events (>15 Minutes With Glucose Concentration >300 mg/dL) | CGM-measured hyperglycemic events (>15 minutes with glucose concentration >300 mg/dL) in each arm. | Not Posted | 3 months | Participants |
| Other Pre-specified | BG-measured Hypoglycemic Events (One BG Record <54 mg/dL | BG-measured Hypoglycemic Events (One BG Record <54 mg/dL | Not Posted | 13 weeks | Participants |
| Other Pre-specified | Worsening of HbA1c From Baseline to 26 Weeks by >0.5% | Worsening of HbA1c from baseline to 26 weeks by >0.5% | Not Posted | 13 weeks | Participants |
| Other Pre-specified | Other Serious Adverse Events (SAE) and Serious Adverse Device Events (SADE) | Other serious adverse events (SAE) and serious adverse device events (SADE) | Not Posted | 13 weeks | Participants |
| Other Pre-specified | Adverse Device Effects (ADE) | Adverse device effects (ADE) | Not Posted | 13 weeks | Participants |
| Other Pre-specified | Unanticipated Adverse Device Effects (UADE) | Unanticipated adverse device effects (UADE) | Not Posted | 13 weeks | Participants |
| Other Pre-specified | Number of Participants With SH Events | For this outcome, mean +/- SD or summary statistics appropriate to the distribution will be tabulated by treatment group | Not Posted | 13 weeks | Participants |
| Other Pre-specified | SH Event Rate Per 100 Person-years | For this outcome, severe hypoglycemia event rate per 100 person-years will be calculated as a rate. | Not Posted | 13 weeks | Participants |
| Other Pre-specified | Number of Participants With DKA Events | For this outcome, number of participants with diabetic ketoacidosis (DKA) will be tabulated. | Not Posted | 13 weeks | Participants |
| Other Pre-specified | DKA Event Rate Per 100 Person-years | For this outcome, the diabetic ketoacidosis event rate per 100 person-years will be calculated as a rate. | Not Posted | 13 weeks | Participants |
| Other Pre-specified | Any Adverse Event Rate Per 100 Person-years | For this outcome, the adverse event rate per 100 person-years calculated as a rate. | Not Posted | 13 weeks | Participants |
| 0 |
| 35 |
| 0 |
| 35 |
| 4 |
| 35 |
| EG001 | Sensor Augmented Pump/Predictive Low Glucose Suspend | Subjects will continue use of home insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Subject may use home pump in PLGS mode if this is supported and compatible with the study sensor. Sensor-Augmented Pump (SAP)/Predictive Low Glucose Suspend (PLGS): Use of personal pump with study CGM & glucometer at home for 13 weeks. | 0 | 35 | 1 | 35 | 0 | 35 |
| Medical Device Site Bleeding | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| COVID-19 | Infections and infestations | Systematic Assessment |
|
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |