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| ID | Type | Description | Link |
|---|---|---|---|
| 2R01DK085623 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Tandem Diabetes Care, Inc. | INDUSTRY |
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This study is intended to test a Web-based Information Tool (WIT) software providing additional information regarding time in range, GMI, hypo- and hyperglycemia risks, variability tracker, daily glycemic profiles, and potential changes of insulin pump parameters, to users of a commercially available Closed-Loop Control (CLC) System (Control-IQ Technology).
This is a randomized two-arm crossover group trial in which both groups will use the CLC (Control-IQ) plus WIT. The difference between the two groups will be the order of the interventions. Each group will undergo screening and collection of baseline data from their personal AID system (Control-IQ) followed by randomization 1:1 into two groups. Both groups will have the same three interventions but will progress in the study in a different order allowing for crossover comparisons. The three interventions are:
The BAM will consist of modules in which information only is given to participants (e.g. time in range, Glucose Management Indicator (GMI), hyper-and hypoglycemic risks, daily glycemic profiles, and variability tracker). The PAM includes auto suggestions for titration of insulin pump parameters every two weeks (ATM) and is aided by a web simulation tool (WST) which can replay 'what if' scenarios for the participant based on various combinations of insulin pump parameter changes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CLC, then CLC+BAM, then CLC+ABC | Active Comparator | Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. |
|
| CLC+ABC, then CLC+BAM, then CLC | Active Comparator | Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CLC + BAM | Device | Closed Loop Control with the Behavioral Adaption Module for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| CGM-measured Percent Time in Range 70-180 mg/dL | The primary outcome for this study is CGM-measured percent time in range 70-180 mg/dL over the last 4-week periods on CLC+ABC versus 2 weeks of the current CLC system. | 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC |
| Measure | Description | Time Frame |
|---|---|---|
| CGM-measured Percent Above 180 mg/dL During the Day | A key secondary outcome is CGM-measured percent above 180mg/dL during the day comparing last 4 weeks of CLC+ABC to 2 weeks of the CLC system alone. | 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC |
| CGM-measured Percent Below 70 mg/dL During the Day |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Sue Brown, MD | University of Virginia 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 |
|---|---|---|---|
| 40329052 | Result | Kovatchev BP, Colmegna P, Pavan J, Diaz Castaneda JL, Villa-Tamayo MF, Koravi CLK, Santini G, Alix C, Stumpf M, Brown SA. Human-machine co-adaptation to automated insulin delivery: a randomised clinical trial using digital twin technology. NPJ Digit Med. 2025 May 6;8(1):253. doi: 10.1038/s41746-025-01679-y. |
| Label | URL |
|---|---|
| Related Info | View source |
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Will follow the NIH Data Sharing Policy and Implementation Guidance. Limited deidentified data will be shared while sharing of complete data sets will be regulated by Data-Sharing Agreements.
Generally following completion of publications.
Limited deidentified data will be shared while sharing of complete data sets will be regulated by Data-Sharing Agreements.
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73 participants were randomized but 1 participant from the "CLC+ABC, then CLC+BAM, then CLC" arm did not complete the study. 72 participants completed.
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| ID | Title | Description |
|---|---|---|
| FG000 | CLC, Then CLC+BAM, Then CLC+ABC | Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks |
| FG001 | CLC+ABC, Then CLC+BAM, Then CLC | Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | CLC, Then CLC+BAM, Then CLC+ABC | Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks |
| 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 | CGM-measured Percent Time in Range 70-180 mg/dL | The primary outcome for this study is CGM-measured percent time in range 70-180 mg/dL over the last 4-week periods on CLC+ABC versus 2 weeks of the current CLC system. | Posted | Mean | Standard Deviation | percentage of time in range | 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC |
|
22 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 | CLC of: CLC, Then CLC+BAM, Then CLC+ABC | Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boris Kovatchev, PhD | UVA Center for Diabetes Technology | 434-924-5592 | BPK2U@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 | Jan 16, 2024 | May 30, 2025 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 17, 2024 | Jun 2, 2025 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 9, 2024 | Oct 17, 2024 | 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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| CLC + ABC | Device | Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks |
|
A key secondary outcome is CGM-measured percent below 70mg/dL during the day comparing last 4 weeks of CLC+ABC to 2 weeks of the CLC system alone. |
| 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC |
| CGM-measured Mean Glucose | A key secondary outcome is CGM-measured mean glucose comparing the last 4 weeks of CLC+ABC to 2 weeks of the CLC system alone. | 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC |
| CGM-measured Coefficient of Variation During the Day | A key secondary outcome is CGM-measured percent coefficient of variation during the day comparing last 4 weeks of CLC+ABC to 2 weeks of the CLC system alone. | 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC |
| Time in Range (70-140 mg/dL) | A key secondary outcome is CGM-measured time in range from 70-140 mg/dL comparing the last 4 weeks of CLC+ABC to 2 weeks of the CLC system alone. | 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC |
| TIR <60 mg/dL | Time below 60 mg/dL as measured by CGM. | 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC |
| Low Blood Glucose Index (LBGI) | 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. | 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC |
| High Blood Glucose Index (HBGI) | 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. | 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC |
| TIR >250 mg/dL | Time above 250 mg/dL as measured by CGM. | 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC |
| TIR >300 mg/dL | Time above 300 mg/dL as measured by CGM. | 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC |
| HbA1c (%) at End of Study | The percentage of glycated hemoglobin. A higher percentage indicates a worse outcome. | Labs taken at the completion of study, approximately 6 months after enrollment; hence, results are stratified only by arm and not by intervention. |
| Technology Expectations Survey | This questionnaire is rated on a 5-point Likert scale and is the baseline version of the Technology Acceptance Survey. Technology Expectations and Technology Experience Survey have identical items, except future tense is used in the Technology Expectations Survey (administered at randomization), while past tense is used in the Technology Experience Survey (administered at the end of each intervention). These surveys yield two subscale scores (burdens and benefits); the score of the items in the burden subscale are inverted before averaging the score of all the items to obtain the total technology acceptance reported here (range: 1-5, with 5 indicating higher acceptance). | Participant baseline |
| Clarke's Hypoglycemia Awareness Scale | Number of individuals with hypoglycemia awareness, reduced hypoglycemia awareness, and in between, based on Clarke's Hypoglycemia Awareness Scale. | 22 weeks |
| Technology Experience Survey | This questionnaire is rated on a 5-point Likert scale and is the endpoint version of the Technology Acceptance Survey. Technology Expectations and Technology Experience Survey have identical items, except future tense is used in the Technology Expectations Survey (administered at randomization), while past tense is used in the Technology Experience Survey (administered at the end of each intervention). These surveys yield two subscale scores (burdens and benefits); the score of the items in the burden subscale are inverted before averaging the score of all the items to obtain the total technology acceptance reported here (range: 1-5, with 5 indicating higher acceptance). The score is not reported for CLC only, as no technology was used during this intervention. | At participant completion, approximately 6 months |
| High Blood Glucose Levels Survey | This questionnaire evaluates generalized avoidance of hyperglycemia across 4 subcategories using items rated on a 5-point Likert scale. Range is 1-5, with 5 indicating higher hyperglycemia avoidance and worry. The total score reported is obtained by averaging the scores of all the items in the survey. | 22 weeks |
| Hypoglycemia Fear Survey | This questionnaire evaluates Fear of Hypoglycemia and each item is rated on a 5-point Likert scale. Range is 1-5, with 5 indicating higher hypoglycemia fear and worry. The total score reported is obtained by averaging the scores of all the items in the survey. | 22 weeks |
| Diabetes Distress Scale | A questionnaire evaluating different domains of diabetes-related distress. Each item is scored on a 6 point Likert scale. Range is 1-6- with scores of 2-2.9 indicating moderate distress and scores > 3.0 indicating severe distress. The total score reported is obtained by averaging the scores of all the items in the survey. | 22 weeks |
| BG001 | CLC+ABC, Then CLC+BAM, Then CLC | Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Weight (kg) | Mean | Standard Deviation | kg |
|
| Height (cm) | Mean | Standard Deviation | cm |
|
| Screening glycated hemoglobin (%) | Mean | Standard Deviation | percentage of glycated hemoglobin |
|
| CLC+BAM of: CLC, Then CLC+BAM, Then CLC+ABC |
Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks |
| OG002 | CLC+ABC of: CLC, Then CLC+BAM, Then CLC+ABC | Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks |
| OG003 | CLC+ABC of: CLC+ABC, Then CLC+BAM, Then CLC | Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks |
| OG004 | CLC+BAM of: CLC+ABC, Then CLC+BAM, Then CLC | Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks |
| OG005 | CLC of: CLC+ABC, Then CLC+BAM, Then CLC | Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks |
|
|
| Secondary | CGM-measured Percent Above 180 mg/dL During the Day | A key secondary outcome is CGM-measured percent above 180mg/dL during the day comparing last 4 weeks of CLC+ABC to 2 weeks of the CLC system alone. | Posted | Mean | Standard Deviation | percentage of time | 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC |
|
|
|
| Secondary | CGM-measured Percent Below 70 mg/dL During the Day | A key secondary outcome is CGM-measured percent below 70mg/dL during the day comparing last 4 weeks of CLC+ABC to 2 weeks of the CLC system alone. | Posted | Mean | Standard Deviation | percentage of time | 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC |
|
|
|
| Secondary | CGM-measured Mean Glucose | A key secondary outcome is CGM-measured mean glucose comparing the last 4 weeks of CLC+ABC to 2 weeks of the CLC system alone. | Posted | Mean | Standard Deviation | mg/dL | 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC |
|
|
|
| Secondary | CGM-measured Coefficient of Variation During the Day | A key secondary outcome is CGM-measured percent coefficient of variation during the day comparing last 4 weeks of CLC+ABC to 2 weeks of the CLC system alone. | Posted | Mean | Standard Deviation | percentage | 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC |
|
|
|
| Secondary | Time in Range (70-140 mg/dL) | A key secondary outcome is CGM-measured time in range from 70-140 mg/dL comparing the last 4 weeks of CLC+ABC to 2 weeks of the CLC system alone. | Posted | Mean | Standard Deviation | percentage of time | 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC |
|
|
|
| Secondary | TIR <60 mg/dL | Time below 60 mg/dL as measured by CGM. | Posted | Mean | Standard Deviation | percentage of time | 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC |
|
|
|
| Secondary | Low Blood Glucose Index (LBGI) | 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. | Posted | Mean | Standard Deviation | index | 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC |
|
|
|
| Secondary | High Blood Glucose Index (HBGI) | 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. | Posted | Mean | Standard Deviation | index | 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC |
|
|
|
| Secondary | TIR >250 mg/dL | Time above 250 mg/dL as measured by CGM. | Posted | Mean | Standard Deviation | percentage of time | 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC |
|
|
|
| Secondary | TIR >300 mg/dL | Time above 300 mg/dL as measured by CGM. | Posted | Mean | Standard Deviation | percentage of time | 2 weeks of CLC, 4 weeks of CLC+BAM, last 4 weeks of CLC+ABC |
|
|
|
| Secondary | HbA1c (%) at End of Study | The percentage of glycated hemoglobin. A higher percentage indicates a worse outcome. | Posted | Mean | Standard Deviation | percentage of glycated hemoglobin | Labs taken at the completion of study, approximately 6 months after enrollment; hence, results are stratified only by arm and not by intervention. |
|
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| Secondary | Technology Expectations Survey | This questionnaire is rated on a 5-point Likert scale and is the baseline version of the Technology Acceptance Survey. Technology Expectations and Technology Experience Survey have identical items, except future tense is used in the Technology Expectations Survey (administered at randomization), while past tense is used in the Technology Experience Survey (administered at the end of each intervention). These surveys yield two subscale scores (burdens and benefits); the score of the items in the burden subscale are inverted before averaging the score of all the items to obtain the total technology acceptance reported here (range: 1-5, with 5 indicating higher acceptance). | This assessment is administered at Baseline, prior to start of the intervention sequence. | Posted | Mean | Standard Deviation | score on a scale | Participant baseline |
|
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| Secondary | Clarke's Hypoglycemia Awareness Scale | Number of individuals with hypoglycemia awareness, reduced hypoglycemia awareness, and in between, based on Clarke's Hypoglycemia Awareness Scale. | Posted | Count of Participants | Participants | 22 weeks |
|
|
|
| Secondary | Technology Experience Survey | This questionnaire is rated on a 5-point Likert scale and is the endpoint version of the Technology Acceptance Survey. Technology Expectations and Technology Experience Survey have identical items, except future tense is used in the Technology Expectations Survey (administered at randomization), while past tense is used in the Technology Experience Survey (administered at the end of each intervention). These surveys yield two subscale scores (burdens and benefits); the score of the items in the burden subscale are inverted before averaging the score of all the items to obtain the total technology acceptance reported here (range: 1-5, with 5 indicating higher acceptance). The score is not reported for CLC only, as no technology was used during this intervention. | Posted | Mean | Standard Deviation | score on a scale | At participant completion, approximately 6 months |
|
|
|
| Secondary | High Blood Glucose Levels Survey | This questionnaire evaluates generalized avoidance of hyperglycemia across 4 subcategories using items rated on a 5-point Likert scale. Range is 1-5, with 5 indicating higher hyperglycemia avoidance and worry. The total score reported is obtained by averaging the scores of all the items in the survey. | Posted | Mean | Standard Deviation | score on a scale | 22 weeks |
|
|
|
| Secondary | Hypoglycemia Fear Survey | This questionnaire evaluates Fear of Hypoglycemia and each item is rated on a 5-point Likert scale. Range is 1-5, with 5 indicating higher hypoglycemia fear and worry. The total score reported is obtained by averaging the scores of all the items in the survey. | Posted | Mean | Standard Deviation | score on a scale | 22 weeks |
|
|
|
| Secondary | Diabetes Distress Scale | A questionnaire evaluating different domains of diabetes-related distress. Each item is scored on a 6 point Likert scale. Range is 1-6- with scores of 2-2.9 indicating moderate distress and scores > 3.0 indicating severe distress. The total score reported is obtained by averaging the scores of all the items in the survey. | Posted | Mean | Standard Deviation | score on a scale | 22 weeks |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | CLC+BAM of: CLC, Then CLC+BAM, Then CLC+ABC | Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks | 0 | 38 | 0 | 38 | 0 | 38 |
| EG002 | CLC+ABC of: CLC, Then CLC+BAM, Then CLC+ABC | Participants will be using closed loop control (CLC) for 2 weeks. Participants will then use closed loop control (CLC) with behavioral adaption module (BAM) for 4 weeks, followed by closed loop control (CLC) adaptive biobehavioral control (ABC) for 16 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks | 0 | 38 | 0 | 38 | 0 | 38 |
| EG003 | CLC+ABC of: CLC+ABC, Then CLC+BAM, Then CLC | Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks | 0 | 35 | 0 | 35 | 0 | 35 |
| EG004 | CLC+BAM of: CLC+ABC, Then CLC+BAM, Then CLC | Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks | 0 | 34 | 0 | 34 | 0 | 34 |
| EG005 | CLC of: CLC+ABC, Then CLC+BAM, Then CLC | Participants will be using closed loop control (CLC) with adaptive biobehavioral control (ABC) for 16 weeks. Participants will then use closed loop control (CLC) with behavioral adaptation module (BAM) for 4 weeks, followed by closed loop control (CLC) for 2 weeks. CLC + BAM: Closed Loop Control with the Behavioral Adaption Module for 4 weeks CLC + ABC: Closed Loop Control with Adaptive Biobehavioral Control for 16 weeks | 0 | 34 | 0 | 34 | 0 | 34 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| Uncertain |
|
| Unaware |
|