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| ID | Type | Description | Link |
|---|---|---|---|
| UC4DK108483 | 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 |
| TypeZero Technologies | INDUSTRY |
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The objective of the study is to assess the efficacy and safety of home use of a Control-to-Range (CTR) closed-loop (CL) system.
The protocol is a 3-month parallel group multi-center randomized trial designed to compare Control-to-Range (CTR) closed-loop (CL) with sensor augmented pump therapy (SAP). Approximately 126 subjects will be entered into the randomized trial at approximately seven clinical sites in the United States, such that at least 110 subjects complete the randomized trial. A maximum of 200 subjects may be enrolled in the study in order to achieve the goal of randomizing 126 subjects.
In order to have a broad range of glycemic control among the subjects, a study goal will be to have a minimum of 50 subjects with HbA1c ≥ 7.5% and 50 with HbA1c < 7.5%.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Artificial Pancreas | Experimental | Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This AP system is designed to help control blood sugar in people living with type 1 diabetes. |
|
| Sensor Augmented Therapy | Active Comparator | Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Artificial Pancreas | Device | Use of CTR at home for 3 months |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time Below 70 mg/dL | CGM-measured % time below 70 mg/dL - 1st co-primary outcome (superiority) | Post randomization (final 11 weeks) |
| Time Above 180 mg/dL | CGM-measured % time above 180 mg/dL - 2nd co-primary outcome (noninferiority) | Post randomization (final 11 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Time Below 54 mg/dL | Percent time CGM readings were below 54 mg/dL | Post randomization (final 11 weeks) |
| Time Below 60 mg/dL | CGM-measured % time below 60 mg/dL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Boris P. Kovatchev, PhD | University of Virginia Center for Diabetes Technology | Principal Investigator |
| Stacey M. Anderson, MD | University of Virginia Center for Diabetes Technology | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| William Sansum Diabetes Center | Santa Barbara | California | 93105 | United States | ||
| Stanford University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32245747 | Background | Kovatchev B, Anderson SM, Raghinaru D, Kudva YC, Laffel LM, Levy C, Pinsker JE, Wadwa RP, Buckingham B, Doyle FJ 3rd, Brown SA, Church MM, Dadlani V, Dassau E, Ekhlaspour L, Forlenza GP, Isganaitis E, Lam DW, Lum J, Beck RW; iDCL Study Group. Erratum. Randomized Controlled Trial of Mobile Closed-Loop Control. Diabetes Care 2020;43:607-615. Diabetes Care. 2020 Jun;43(6):1366. doi: 10.2337/dc20-er06. Epub 2020 Apr 3. No abstract available. | |
| 31937608 | Result |
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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, meal content, boluses, & exercise 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.
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Participants who used a personal Dexcom G4 or G5 CGM pre-study for at least 21 of the prior 28 days proceeded directly to randomization. For these participants, the data downloaded from the personal CGM provided the 2-week baseline data. All others wore a blinded study CGM for 2 weeks to collect baseline data, followed by 2 weeks of training using an unblinded study CGM. Successful completion of the run-in was followed by randomization.
This parallel-group, multicenter, randomized unblinded clinical trial was conducted at 7 US university centers. Participants were diagnosed with type 1 diabetes, treated with insulin for at least 1 year, using pump therapy for at least 6 months, age 14 and above, & HbA1c <10.5% (91 mmol/mol). A study goal was to have at least 50 participants with HbA1c<7.5% (58 mmol/mol) and at least 50 participants with HbA1c >7.5% (58 mmol/mol). Participants were screened October 2017 - May 2018.
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| ID | Title | Description |
|---|---|---|
| FG000 | Artificial Pancreas (Closed Loop Control) | Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This AP system is designed to help control blood sugar in people living with type 1 diabetes. Artificial Pancreas: Use of CTR at home for 3 months |
| FG001 | Sensor Augmented Therapy | Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Sensor Augmented Therapy: Use of personal pump with study CGM & glucometer at home for 3 months |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Artificial Pancreas (Closed Loop Control) | Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This AP system is designed to help control blood sugar in people living with type 1 diabetes. Artificial Pancreas: Use of CTR at home for 3 months |
| 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 | Time Below 70 mg/dL | CGM-measured % time below 70 mg/dL - 1st co-primary outcome (superiority) | Posted | Mean | Standard Deviation | percentage of total CGM time | Post randomization (final 11 weeks) |
|
13 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 | Artificial Pancreas (Closed Loop Control) | Subjects will be provided the Artificial Pancreas (AP) system which includes the inControl Diabetes Management Platform, a study insulin pump, study continuous glucose monitor (CGM), and a study glucometer. This AP system is designed to help control blood sugar in people living with type 1 diabetes. Artificial Pancreas: Use of CTR at home for 3 months |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hypoglycemic seizure | Nervous system disorders | Systematic Assessment | Severe hypoglycemia on 2/26/18 at ~5:30PM. Spouse noticed convulsion during sleep CGM reading = 50 mg/dl. Spouse provided two boxes of juice & glucose tablets. Participant doesn't recall episode. Complete recovery after rescue carbohydrates. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gastroenteritis | Gastrointestinal disorders | Systematic Assessment | Nausea & vomiting started 02/13/18. No fever. Exposed GI illness day before. Blood glucose=99 mg/dl; serum ketones=1.2 mmol/L. In follow up call, ketones=1.1 mmol/L one hour later. On 02/14/18, ketones=0.3 mmol/L. Complete recovery. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boris Kovatchev, PhD | University of Virginia Center for Diabetes Technology | 434-982-0602 | mc7m@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 | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Feb 9, 2018 | Sep 26, 2022 | Prot_SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 6, 2018 | Aug 5, 2022 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D019397 | Pancreas, Artificial |
| ID | Term |
|---|---|
| D001187 | Artificial Organs |
| D013523 | Surgical Equipment |
| D004864 | Equipment and Supplies |
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| DexCom, Inc. |
| INDUSTRY |
| Roche Diagnostic Ltd. | INDUSTRY |
| Ascensia Diabetes Care | INDUSTRY |
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| Sensor Augmented Therapy | Other | Use of personal pump with study CGM & glucometer at home for 3 months |
|
|
| Post randomization (final 11 weeks) |
| Time in Range 70-180 mg/dL | CGM-measured % in range 70-180 mg/dL | Post randomization (final 11 weeks) |
| Time in Range 70-140 mg/dL | CGM-measured % time in range 70-140 mg/dL | Post randomization (final 11 weeks) |
| Time Above 250 mg/dL | CGM-measured % time above 250 mg/dL | Post randomization (final 11 weeks) |
| Time Above 300 mg/dL | CGM-measured % time above 300 mg/dL | Post randomization (final 11 weeks) |
| Coefficient of Variation | CGM-measured coefficient of variation (CV) | Post randomization (final 11 weeks) |
| Stanford |
| California |
| 94304 |
| United States |
| Barbara Davis Center, University of Colorado | Aurora | Colorado | 80045 | United States |
| Harvard University (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 |
| University of Virginia Center for Diabetes Technology | Charlottesville | Virginia | 22903 | United States |
| Kovatchev B, Anderson SM, Raghinaru D, Kudva YC, Laffel LM, Levy C, Pinsker JE, Wadwa RP, Buckingham B, Doyle FJ 3rd, Brown SA, Church MM, Dadlani V, Dassau E, Ekhlaspour L, Forlenza GP, Isganaitis E, Lam DW, Lum J, Beck RW; iDCL Study Group. Randomized Controlled Trial of Mobile Closed-Loop Control. Diabetes Care. 2020 Mar;43(3):607-615. doi: 10.2337/dc19-1310. Epub 2020 Jan 14. |
| BG001 | Sensor Augmented Therapy | Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Sensor Augmented Therapy: Use of personal pump with study CGM & glucometer at home for 3 months |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants | No |
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| Diabetes duration at randomization (years) | Count of Participants | Participants |
|
| Prior CGM use | Count of Participants | Participants |
|
| BMI at enrollment (kg/m2) | Count of Participants | Participants |
|
| HbA1c at randomization: laboratory | Count of Participants | Participants |
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| C-Peptide at randomization (nmol/L): Laboratory | Count of Participants | Participants |
|
| Diabetes ketoacidosis events in the last 12 months | Count of Participants | Participants |
|
| Severe hypoglycemic events in past 12 months | Count of Participants | Participants |
|
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|
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| Primary | Time Above 180 mg/dL | CGM-measured % time above 180 mg/dL - 2nd co-primary outcome (noninferiority) | Posted | Mean | Standard Deviation | percentage of total CGM time | Post randomization (final 11 weeks) |
|
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| Secondary | Time Below 54 mg/dL | Percent time CGM readings were below 54 mg/dL | Posted | Mean | Standard Deviation | Percentage | Post randomization (final 11 weeks) |
|
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| Secondary | Time Below 60 mg/dL | CGM-measured % time below 60 mg/dL | Posted | Mean | Standard Deviation | Percentage | Post randomization (final 11 weeks) |
|
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|
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| Secondary | Time in Range 70-180 mg/dL | CGM-measured % in range 70-180 mg/dL | Posted | Mean | Standard Deviation | Percentage | Post randomization (final 11 weeks) |
|
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|
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| Secondary | Time in Range 70-140 mg/dL | CGM-measured % time in range 70-140 mg/dL | Posted | Mean | Standard Deviation | Percentage | Post randomization (final 11 weeks) |
|
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| Secondary | Time Above 250 mg/dL | CGM-measured % time above 250 mg/dL | Posted | Mean | Standard Deviation | Percentage | Post randomization (final 11 weeks) |
|
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| Secondary | Time Above 300 mg/dL | CGM-measured % time above 300 mg/dL | Posted | Mean | Standard Deviation | Percentage | Post randomization (final 11 weeks) |
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| Secondary | Coefficient of Variation | CGM-measured coefficient of variation (CV) | Posted | Mean | Standard Deviation | Percentage | Post randomization (final 11 weeks) |
|
|
|
|
| 0 |
| 65 |
| 1 |
| 65 |
| 0 |
| 65 |
| EG001 | Sensor Augmented Therapy | Subjects will continue to use their personal insulin pump with a study continuous glucose monitor (CGM) and study glucometer. Sensor Augmented Therapy: Use of personal pump with study CGM & glucometer at home for 3 months | 0 | 62 | 0 | 62 | 2 | 62 |
|
| Dehydration | Metabolism and nutrition disorders | Systematic Assessment | Participant ran 100k race on 5/12/18.Felt overheated & vomiting x2 after 52.8 miles (13.5h run time). Admitted to the ER for dehydration & DKA risk. BG in 200s & ketones were negative. Complete recovery. |
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| Surgery | Surgical and medical procedures | Systematic Assessment | Planned in-patient surgery on 4/10/18. Removal of Whartin growth behind left ear. Complete recovery. |
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The second co-primary end point was noninferiority in CGM-measured time above 180 mg/dL, with a noninferiority limit of 5%. The treatment groups were compared using linear models while adjusting for age, corresponding baseline value, previous CGM use, and a random center effect. Missing baseline data were handled by direct likelihood method. Model residuals were confirmed to be approximately normally distributed. |