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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK085623 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Roche Diagnostic Ltd. | INDUSTRY |
| TypeZero Technologies, LLC | INDUSTRY |
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The purpose of this study is to use an investigational type of technology called Closed-Loop Control (CLC) Medical Platform System to help control blood sugar in people with type 1 diabetes mellitus in a home setting.
The CLC is an "artificial pancreas" (AP) application that uses advanced closed loop control algorithms to automatically manage blood glucose levels for people with Type 1 Diabetes. The system modulates insulin to keep blood glucose in a targeted range. The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive.These functionalities occur in a randomized cross-over design, each occurring for 8 weeks. These modalities are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Order of intervention will be 1) SAP; 2) USS + SAP(d); 3) USS +CLC (d); 4) USS + SAP(d)
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| Group B | Experimental | Order of intervention will be 1)USS + SAP(d) ; 2)USS +CLC (d); 3) USS + SAP(d); 4) SAP
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLC | Device | The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive. |
| Measure | Description | Time Frame |
|---|---|---|
| Time <70 mg/dl by CGM | Overnight CLC achieved by USS+SAP(d) (also known at Evening-Night CLC) will be superior to SAP alone in terms of reduced incidence and risk for hypoglycemia overnight without deterioration in hemoglobin A1c. Outcomes will be stratified by Hemoglobin A1c < 7.5% vs ≥7.5% and time of day. | 8 weeks |
| Hemoglobin A1c | Overnight CLC achieved by USS+SAP(d) (also known as Evening-Night CLC) will be superior to SAP alone in terms of reduced incidence and risk for hypoglycemia overnight without deterioration in hemoglobin A1c. Outcomes will be stratified by Hemoglobin A1c < 7.5% vs ≥7.5% and time of day. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time Between 70-180 mg/dL by CGM | Time in target range 70-180 mg/dL measured by CGM | 8 weeks |
| Time >180 mg/dL by CGM | Time in hyperglycemia range >180 mg/dL measured by CGM |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sue A. Brown, MD | UVA Center for Diabetes Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Center for Diabetes Technology | Charlottesville | Virginia | 22903 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32864597 | Derived | Kovatchev BP, Kollar L, Anderson SM, Barnett C, Breton MD, Carr K, Gildersleeve R, Oliveri MC, Wakeman CA, Brown SA. Evening and overnight closed-loop control versus 24/7 continuous closed-loop control for type 1 diabetes: a randomised crossover trial. Lancet Digit Health. 2020 Feb;2(2):e64-e73. doi: 10.1016/S2589-7500(19)30218-3. Epub 2020 Jan 3. |
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Generally will be available after publications completed.
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103 participants signed informed consent and were assessed for eligibility.10 were excluded prior to randomization (7 did not meet inclusion criteria, 2 declined to participate, 1 lost to followup). 93 participants were randomized and assigned to groups.
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| ID | Title | Description |
|---|---|---|
| FG000 | Group A | Order of intervention will be 1) SAP; 2) USS + SAP(d); 3) USS +CLC (d); 4) USS + SAP(d) CLC: The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive.
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| FG001 | Group B | Order of intervention will be 1)USS + SAP(d) ; 2)USS +CLC (d); 3) USS + SAP(d); 4) SAP CLC: The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive.
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| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
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| Period 1: Randomization-Study Session 1 |
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| Period 2 |
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| Period 3 |
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| Phase 4 |
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The analyzed group includes participants who completed two study sessions or more.
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| ID | Title | Description |
|---|---|---|
| BG000 | Group A | Order of intervention will be 1) SAP; 2) USS + SAP(d); 3) USS +CLC (d); 4) USS + SAP(d) CLC: The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive. |
| BG001 |
| 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, 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 | Time <70 mg/dl by CGM | Overnight CLC achieved by USS+SAP(d) (also known at Evening-Night CLC) will be superior to SAP alone in terms of reduced incidence and risk for hypoglycemia overnight without deterioration in hemoglobin A1c. Outcomes will be stratified by Hemoglobin A1c < 7.5% vs ≥7.5% and time of day. | This primary analysis was confined to the phase of the study comparing SAP to Evening-Night CLC only when combining group A and B. Data on 24/7 CLC phase is included in secondary outcomes. | Posted | Mean | Standard Deviation | percentage of time | 8 weeks |
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Approximately 10-11 months.
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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 | Sensor-Augmented Pump Therapy (SAP) | 8 week study phase for both Group A and Group B that underwent the same procedures in different orders. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Appendicitis | Gastrointestinal disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Severe Hypoglycemia | Endocrine disorders | Systematic Assessment | Hypoglycemia requiring the assistance of a third party. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sue Brown, MD | University of Virginia | 434-982-0602 | sab2f@virginia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP_ICF | Yes | Yes | Yes | Study Protocol, Statistical Analysis Plan, and Informed Consent Form | Aug 6, 2018 | Apr 6, 2020 | Prot_SAP_ICF_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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| Tandem Diabetes Care, Inc. |
| INDUSTRY |
| DexCom, Inc. | INDUSTRY |
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| 8 weeks |
| Mean Glucose by CGM | Mean glucose measured by CGM overall in mmol/L | 8 weeks |
| Low Blood Glucose Index (LBGI) | Index measure of low blood glucose risk. This is an index that indicates risk of hypoglycemia with low values indicating lower risk of hypoglycemia (particularly values 1 or lower). | 8 weeks |
| High Blood Glucose Index (HBGI) | Index measure of high blood glucose risk. | 8 weeks |
| CGM <70mg/dL | Percentage time <70mg/dL measured by CGM in three study phases combining Group A and B. | 8 weeks |
| Hemoglobin A1c by Study Session | Hemoglobin A1c after each 8 weeks study session by Group A and Group B. | 8 weeks |
| Disliked mobile system |
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| Adverse Event prior to intervention |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| Group B |
Order of intervention will be 1)USS + SAP(d) ; 2)USS +CLC (d); 3) USS + SAP(d); 4) SAP CLC: The CLC will be deployed with different functionalities at different stages of the trial, resulting in variation in what the subject will be responsible for and what the system will drive. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Hemoglobin A1c | Mean | Standard Deviation | percent |
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| Primary | Hemoglobin A1c | Overnight CLC achieved by USS+SAP(d) (also known as Evening-Night CLC) will be superior to SAP alone in terms of reduced incidence and risk for hypoglycemia overnight without deterioration in hemoglobin A1c. Outcomes will be stratified by Hemoglobin A1c < 7.5% vs ≥7.5% and time of day. | This primary analysis was confined to the phase of the study comparing SAP to Evening-Night CLC only when combining group A and B and included the baseline HbA1c and final HbA1c. Data on HbA1c by study phase is included in secondary outcomes. | Posted | Mean | Standard Deviation | percentage of glycated hemoglobin | 8 weeks |
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| Secondary | Time Between 70-180 mg/dL by CGM | Time in target range 70-180 mg/dL measured by CGM | Posted | Mean | Standard Deviation | percentage of time | 8 weeks |
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| Secondary | Time >180 mg/dL by CGM | Time in hyperglycemia range >180 mg/dL measured by CGM | Posted | Mean | Standard Deviation | percentage of time | 8 weeks |
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| Secondary | Mean Glucose by CGM | Mean glucose measured by CGM overall in mmol/L | Posted | Mean | Standard Deviation | mmol/L | 8 weeks |
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| Secondary | Low Blood Glucose Index (LBGI) | Index measure of low blood glucose risk. This is an index that indicates risk of hypoglycemia with low values indicating lower risk of hypoglycemia (particularly values 1 or lower). | Posted | Mean | Standard Deviation | index | 8 weeks |
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| Secondary | High Blood Glucose Index (HBGI) | Index measure of high blood glucose risk. | Posted | Mean | Standard Deviation | index | 8 weeks |
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| Secondary | CGM <70mg/dL | Percentage time <70mg/dL measured by CGM in three study phases combining Group A and B. | Posted | Mean | Standard Deviation | Percentage of time | 8 weeks |
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| Secondary | Hemoglobin A1c by Study Session | Hemoglobin A1c after each 8 weeks study session by Group A and Group B. | Posted | Mean | Standard Deviation | percentage of glycated hemoglobin | 8 weeks |
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| 0 |
| 93 |
| 1 |
| 93 |
| 5 |
| 93 |
| EG001 | Evening and Overnight Closed-Loop Control | 8 week study phases (2) for both Group A and Group B that underwent the same procedures in different orders. | 0 | 93 | 1 | 93 | 14 | 93 |
| EG002 | 24/7 Closed-Loop Control | 8 week study phase for both Group A and Group B that underwent the same procedures in different orders. | 0 | 93 | 0 | 93 | 7 | 93 |
| EG003 | Other | This includes any study periods outside of other study phases listed such as screening and washout periods for both Group A and Group B that underwent the same procedures in different orders. | 0 | 93 | 1 | 93 | 9 | 93 |
| Hip Replacement Surgery | Surgical and medical procedures | Systematic Assessment |
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| Renal Cell Carcinoma with Surgical Resection | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Systematic Assessment |
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| Hyperglycemia with ketosis not meeting diabetes ketoacidosis criteria | Endocrine disorders | Systematic Assessment | Significantly elevated ketones requiring intervention without meeting DCCT criteria for diabetic ketoacidosis |
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| Trauma | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Infections requiring medications or interventions | Infections and infestations | Systematic Assessment |
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| Conditions requiring steroid use | Musculoskeletal and connective tissue disorders | Systematic Assessment | e.g. cervical radiculopathy, knee injury, tenosynovitis, dermatitis |
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| Outpatient surgery or procedure | Surgical and medical procedures | Systematic Assessment |
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| New onset Crohn's disease | Gastrointestinal disorders | Systematic Assessment |
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| Burn | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| New onset edema requiring medications | Vascular disorders | Systematic Assessment |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Session 3 (Gp A 24/7 CLC; Gp B evening-night CLC |
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| Session 4 (Gp A Evening-Night CLC; Gp B SAP) |
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