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| ID | Type | Description | Link |
|---|---|---|---|
| U01DK127551-03 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Jaeb Center for Health Research | OTHER |
| University of Colorado, Denver | OTHER |
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The goal of this clinical trial is to obtain safety data and exploratory glycemic control data from use of an at-home closed loop control (CLC) system (t:slim X2 with Control-IQ Technology) with periodic parameter adjustments driven by an AI-based Advisor system in young children with Type 1 Diabetes. The main endpoints this study aims to answer is the safety and efficacy of the use of the AI-driven pump parameters. Participants will use the study system (pump and Continuous Glucose Monitor) in closed-loop mode for eight weeks.
In this single-arm pilot study of an AI Advisor-driven closed loop system initiation and parameter adaptation in youth age 2 to <6 years old, participants will use the Tandem t:slim X2 with Control-IQ and t:connect mobile application and Dexcom G6 or G7 system, connected to the University of Virginia (UVA) cloud-based Physician Dashboard for eight weeks at home.The key safety outcomes are adverse events related to hypoglycemia and hyperglycemia, CGM-measured time spent below 54mg/dL, and CGM-measured time spent above 250 mg/dL. CGM-measured endpoints will be tested against baseline for non-inferiority.Glycemic outcomes including time in target range 70-180 mg/dL (TIR) and various other CGM measures of hypo- and hyperglycemia will be assessed and tested for superiority against baseline and a matched historical control population from the prior PEDAP study that did not involve the use of any AI-driven pump parameters. Up to 45 screened participants with the goal of at least 30 participants completing the study pump use period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AI Advisor-driven at-home closed loop system initiation and parameter adaptation | Experimental | In this single-arm intervention trial, all participants will use the study system (t:slim X2 with Control-IQ Technology and Dexcom Continuous Glucose Monitor) in closed-loop mode for 8 weeks at home with periodic parameter adjustment driven by an AI-based Advisor system. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AI-based Advisor system | Device | Tandem t:slim X2 with Control-IQ and t:connect mobile application and Dexcom G6 or G7 system, connected to UVA cloud-based Physician Dashboard with insulin pump parameters driven by an AI-based Advisor system. |
| Measure | Description | Time Frame |
|---|---|---|
| Safety Endpoint (Tested for Non-inferiority Compared to Baseline) CGM Measured (a) | % of time below 54 mg/dL | Baseline and Weeks 1-8 |
| Safety Endpoint (Tested for Non-inferiority Compared to Baseline) CGM Measured (b) | % of time above 250 mg/dL | Baseline and Weeks 1-8 |
| Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (a) | % of time in range 70-180 mg/dL | Baseline and Weeks 1-8 |
| Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (b) | Mean glucose | Baseline and Weeks 1-8 |
| Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (c) | % of time >250 mg/dL | Baseline and Weeks 1-8 |
| Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (d) | % of time <70 mg/dL | Baseline and Weeks 1-8 |
| Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (e) | % of time <54 mg/dL | Baseline and Weeks 1-8 |
| Measure | Description | Time Frame |
|---|---|---|
| CGM Measured Time in Range | % of time spent within range 70 mg/dL-140 mg/dL. | Baseline and Weeks 1-8 |
| CGM Measured (a) | % of time >180 mg/dL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| John Lum, MS | Jaeb Center for Health Research | Study Director |
| Raj P Wadwa, MD | Barbara Davis Center, University of Colorado | Principal Investigator |
| Marc D Breton, Ph.D. | University of Virginia Center for Diabetes Technology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Stanford | California | 94305 | United States | ||
| Barbara Davis Center, University of Colorado |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40152109 | Result | Pavan J, Cobry E, Reed ZW, Villa-Tamayo MF, Diaz C JL, DeBoer MD, Schoelwer M, Jost E, Kingman R, Holmes V, Lum JW, Koravi CLK, Buckingham B, Beck R, Wadwa RP, Breton MD; PEDAP-AI Trial Study Group. Algorithm-Driven Initiation and Adaptation of Hybrid Closed-Loop in Young Children with Type 1 Diabetes: A Pilot Study. Diabetes Technol Ther. 2025 Aug;27(8):587-596. doi: 10.1089/dia.2024.0650. Epub 2025 Mar 28. |
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Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals in the scientific community
Data will be made available after the primary publications of each study site.
The Data Sharing Agreements will be formulated by the study team.
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Did not meet screening eligibility (N=1)
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| ID | Title | Description |
|---|---|---|
| FG000 | AI Advisor-driven At-home Closed Loop System Initiation and Parameter Adaptation | In this single-arm intervention trial, all participants will use the study system (t:slim X2 with Control-IQ Technology and Dexcom Continuous Glucose Monitor) in closed-loop mode for 8 weeks at home with periodic parameter adjustment driven by an AI-based Advisor system. AI-based Advisor system: Tandem t:slim X2 with Control-IQ and t:connect mobile application and Dexcom G6 or G7 system, connected to University of Virginia (UVA) cloud-based Physician Dashboard with insulin pump parameters driven by an AI-based Advisor system. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | AI Advisor-driven At-home Closed Loop System Initiation and Parameter Adaptation | In this single-arm intervention trial, all participants will use the study system (t:slim X2 with Control-IQ Technology and Dexcom Continuous Glucose Monitor) in closed-loop mode for 8 weeks at home with periodic parameter adjustment driven by an AI-based Advisor system. AI-based Advisor system: Tandem t:slim X2 with Control-IQ and t:connect mobile application and Dexcom G6 or G7 system, connected to UVA cloud-based Physician Dashboard with insulin pump parameters driven by an AI-based Advisor system. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | 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 | Safety Endpoint (Tested for Non-inferiority Compared to Baseline) CGM Measured (a) | % of time below 54 mg/dL | Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation. | Posted | Mean | Standard Deviation | percentage of time | Baseline and Weeks 1-8 |
|
8 weeks
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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 | AI Advisor-driven At-home Closed Loop System Initiation and Parameter Adaptation | In this single-arm intervention trial, all participants will use the study system (t:slim X2 with Control-IQ Technology and Dexcom Continuous Glucose Monitor) in closed-loop mode for 8 weeks at home with periodic parameter adjustment driven by an AI-based Advisor system. AI-based Advisor system: Tandem t:slim X2 with Control-IQ and t:connect mobile application and Dexcom G6 or G7 system, connected to UVA cloud-based Physician Dashboard with insulin pump parameters driven by an AI-based Advisor system. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe Hypoglycemia | Endocrine disorders | Non-systematic Assessment | severe hypoglycemic event is defined as a hypoglycemic event that a) required assistance of another person due to altered consciousness, and b) required another person to actively administer carbohydrate, glucagon, or other resuscitative actions |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hyperglycemia with or without Ketosis | Endocrine disorders | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Marc Breton, PhD | University of Virginia Center for Diabetes Technology | 434-982-6484 | marc.breton@virginia.edu |
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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 | Feb 14, 2024 | Sep 6, 2024 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 10, 2024 | Sep 24, 2024 | SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 11, 2024 | Sep 24, 2024 | 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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| Stanford University |
| OTHER |
In this single-arm intervention trial, all participants will use the study system (pump and CGM) in closed-loop mode for 8 weeks.
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| Baseline and Weeks 1-8 |
| CGM Measured (b) | % of time >300 mg/dL | Baseline and Weeks 1-8 |
| CGM Measured (c) | % of time <60 mg/dL | Baseline and Weeks 1-8 |
| CGM Measured (d) | Glucose standard deviation | Baseline and Weeks 1-8 |
| CGM Measured (e) | Glucose coefficient of variation | Baseline and Weeks 1-8 |
| CGM Measured (f) | The high blood glucose index (HBGI) is based on a nonlinear transformation of blood glucose values that corrects for the asymmetry of the glucose scale. This transformation maps glucose values into a risk space (minimum risk = 0), where higher values correspond to higher risk. Values below 10 suggest low to moderate risk. | Baseline and Weeks 1-8 |
| CGM Measured (g) | The low blood glucose index (LBGI) is based on a nonlinear transformation of blood glucose values that corrects for the asymmetry of the glucose scale. This transformation maps glucose values into a risk space (minimum risk = 0), where higher values correspond to higher risk. Values <1 suggest low risk of hypoglycemia. | Baseline and Weeks 1-8 |
| CGM Measured (h) | Weekly hyperglycemic event rate | Baseline and Weeks 1-8 |
| CGM Measured (i) | Weekly hypoglycemic event rate | Baseline and Weeks 1-8 |
| Binary Outcome 1 | Number of participants whose % of time in range 70-180 mg/dL improved by 5% or more from baseline to 8 weeks. | Baseline and Weeks 1-8 |
| Binary Outcome 2 | Number of participants whose % of time in range 70-180 mg/dL improved by 10% or more from baseline to 8 weeks. | Baseline and Weeks 1-8 |
| Binary Outcome 3 | Participants with % of time in range 70-180 mg/dL >70% and % of time <70 mg/dL <4% | Baseline and Weeks 1-8 |
| Total Daily Insulin | Total daily insulin (units/kg) | Baseline and Weeks 1-8 |
| Basal Insulin | Percentage of total insulin delivered via basal administration. | Baseline and Weeks 1-8 |
| Aurora |
| Colorado |
| 80045 |
| United States |
| University of Virginia | Charlottesville | Virginia | 22903 | United States |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Body Mass Index Percentile | Median | Inter-Quartile Range | percentage |
|
| Parent Education | Count of Participants | Participants |
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| Annual Household Income | Count of Participants | Participants |
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| Health Insurance | Count of Participants | Participants |
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| HbA1c | Mean | Standard Deviation | percentage of glycated hemoglobin |
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| Insulin Modality | Count of Participants | Participants |
|
| Total Daily Insulin | Mean | Standard Deviation | U/kg/day |
|
| Number of Pump Boluses or Injections of Short-Acting Insulin per Day | Median | Inter-Quartile Range | Pump boluses per day |
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| Diabetic Ketoacidosis (DKA) in last 12 months | Count of Participants | Participants |
|
| Severe hypoglycemia (SH) in Last 12 Months | Count of Participants | Participants |
|
| Diabetes Duration | Median | Inter-Quartile Range | months |
|
| OG001 | AI Advisor-driven At-home Closed Loop System Initiation and Parameter Adaptation | Participants used the Tandem t:slim X2 insulin pump with Control-IQ technology for 8 weeks. Initial and adaptive pump settings were guided by an AI-based advisor through the UVA Clinical Portal. Investigators reviewed and could override AI-generated recommendations. This period was designed to evaluate the safety and efficacy of algorithm-driven insulin delivery in a pediatric population. |
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| Primary | Safety Endpoint (Tested for Non-inferiority Compared to Baseline) CGM Measured (b) | % of time above 250 mg/dL | Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation. | Posted | Mean | Standard Deviation | percentage of time | Baseline and Weeks 1-8 |
|
|
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| Primary | Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (a) | % of time in range 70-180 mg/dL | Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation. | Posted | Mean | Standard Deviation | percentage of time | Baseline and Weeks 1-8 |
|
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| Primary | Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (b) | Mean glucose | Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation. | Posted | Mean | Standard Deviation | mg/dl | Baseline and Weeks 1-8 |
|
|
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| Primary | Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (c) | % of time >250 mg/dL | Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation. | Posted | Mean | Standard Deviation | percentage of time | Baseline and Weeks 1-8 |
|
|
|
| Primary | Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (d) | % of time <70 mg/dL | Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation. | Posted | Mean | Standard Deviation | percentage of time | Baseline and Weeks 1-8 |
|
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| Primary | Hierarchical Efficacy Endpoints (Tested for Superiority Compared With Baseline) CGM Measured (e) | % of time <54 mg/dL | Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation. | Posted | Mean | Standard Deviation | percentage of time | Baseline and Weeks 1-8 |
|
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| Secondary | CGM Measured Time in Range | % of time spent within range 70 mg/dL-140 mg/dL. | Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation. | Posted | Mean | Standard Deviation | percentage of time | Baseline and Weeks 1-8 |
|
|
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| Secondary | CGM Measured (a) | % of time >180 mg/dL | Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation. | Posted | Mean | Standard Deviation | percentage of time | Baseline and Weeks 1-8 |
|
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| Secondary | CGM Measured (b) | % of time >300 mg/dL | Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation. | Posted | Mean | Standard Deviation | percentage of time | Baseline and Weeks 1-8 |
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| Secondary | CGM Measured (c) | % of time <60 mg/dL | Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation. | Posted | Mean | Standard Deviation | percentage of time | Baseline and Weeks 1-8 |
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| Secondary | CGM Measured (d) | Glucose standard deviation | Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation. | Posted | Mean | Standard Deviation | mg/dl | Baseline and Weeks 1-8 |
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| Secondary | CGM Measured (e) | Glucose coefficient of variation | Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation. | Posted | Mean | Standard Deviation | percent | Baseline and Weeks 1-8 |
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| Secondary | CGM Measured (f) | The high blood glucose index (HBGI) is based on a nonlinear transformation of blood glucose values that corrects for the asymmetry of the glucose scale. This transformation maps glucose values into a risk space (minimum risk = 0), where higher values correspond to higher risk. Values below 10 suggest low to moderate risk. | Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation. | Posted | Mean | Standard Deviation | index | Baseline and Weeks 1-8 |
|
|
|
| Secondary | CGM Measured (g) | The low blood glucose index (LBGI) is based on a nonlinear transformation of blood glucose values that corrects for the asymmetry of the glucose scale. This transformation maps glucose values into a risk space (minimum risk = 0), where higher values correspond to higher risk. Values <1 suggest low risk of hypoglycemia. | Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation. | Posted | Mean | Standard Deviation | index | Baseline and Weeks 1-8 |
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| Secondary | CGM Measured (h) | Weekly hyperglycemic event rate | Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation. | Posted | Mean | Standard Deviation | events | Baseline and Weeks 1-8 |
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| Secondary | CGM Measured (i) | Weekly hypoglycemic event rate | Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation. | Posted | Mean | Standard Deviation | events | Baseline and Weeks 1-8 |
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| Secondary | Binary Outcome 1 | Number of participants whose % of time in range 70-180 mg/dL improved by 5% or more from baseline to 8 weeks. | Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation. | Posted | Count of Participants | Participants | Baseline and Weeks 1-8 |
|
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| Secondary | Binary Outcome 2 | Number of participants whose % of time in range 70-180 mg/dL improved by 10% or more from baseline to 8 weeks. | Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation. | Posted | Count of Participants | Participants | Baseline and Weeks 1-8 |
|
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| Secondary | Binary Outcome 3 | Participants with % of time in range 70-180 mg/dL >70% and % of time <70 mg/dL <4% | Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation. | Posted | Count of Participants | Participants | Baseline and Weeks 1-8 |
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| Secondary | Total Daily Insulin | Total daily insulin (units/kg) | Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation. | Posted | Mean | Standard Deviation | U/kg | Baseline and Weeks 1-8 |
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| Secondary | Basal Insulin | Percentage of total insulin delivered via basal administration. | Three participants were excluded due to lack of data. To meet criteria for inclusion, participants had to provide at least 168 hours of CGM data during baseline and the 8-week follow-up period and remain in closed loop for at least 50% of the 8-week period after closed loop initiation. | Posted | Mean | Standard Deviation | percentage of total insulin | Baseline and Weeks 1-8 |
|
|
|
| 0 |
| 32 |
| 3 |
| 32 |
| 5 |
| 32 |
|
| Diabetic Ketoacidosis | Endocrine disorders | Non-systematic Assessment | Hyperglycemia: Blood glucose level ≥ 250 mg/dL (13.9 mmol/L) Ketosis: Presence of moderate to large ketonuria or Serum β-hydroxybutyrate ≥ 3.0 mmol/L Metabolic Acidosis: Arterial or venous pH < 7.3 and/or Serum bicarbonate < 15-18 mmol/L |
|
| Other serious adverse events | Endocrine disorders | Non-systematic Assessment | Hypoglycemia due to user error when changing infusion set. |
|
| Gastroenteritis | Gastrointestinal disorders | Non-systematic Assessment |
|
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |