Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 2R01DK085623-10 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
Not provided
Not provided
Not provided
The purpose of this pilot study is to test the safety and feasibility of using two or three research modules in conjunction with an automated insulin delivery device (AID).
This concept is implemented in the Adaptive Biobehavioral Control (ABC) system - ABC will use human-machine co-adaptation of AID, recognizing both the necessity for the control algorithm to adapt to changes in human physiology, and the necessity for the person to adapt to AID action. ABC will be implemented on the Web Information Tool (WIT) platform/system and includes the following modules to be used alongside the automated insulin delivery device facilitating behavioral adaptation:
Design: Two-week baseline use of personal AID system followed by randomization 1:1 into two groups.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | AID + Auto Titration Module (ATM) and Web Simulation Tool (WST) for 6 weeks |
|
| Group 2 | Experimental | AID + Auto Titration Module (ATM) and Web Simulation Tool (WST) +Behavioral Adaptation Module (BAM) for 6 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Web Simulation Tool (WST) | Device | WST will allow users of the Control-IQ system replay treatment scenarios in computer simulation, thereby allowing user training with carbohydrate and insulin action. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of SAE or ADE Related to the Use of ATM / WST and BAM Modules. | Safety assessment of ATM / WST and BAM modules by assessing serious adverse events or adverse device effects deemed related to the use of ATM/WST and BAM modules specifically. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Time in Range | Percent of CGM readings in the target ranges of 70-180mg/dL from 2 weeks of baseline compared to last 2 weeks of treatment period. | 6 weeks |
| Time in Hypoglycemia | Percent of CGM readings <70 mg/dL |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Sue Brown, MD | University of Virginia | 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 |
|---|---|---|---|
| 38662425 | Background | Colmegna P, McFadden R, Fabris C, Lobo B, Nass R, Oliveri MC, Brown SA, Kovatchev B. Adaptive Biobehavioral Control: A Pilot Analysis of Human-Machine Coadaptation in Type 1 Diabetes. Diabetes Technol Ther. 2024 Sep;26(9):644-651. doi: 10.1089/dia.2023.0399. Epub 2024 Apr 30. |
Not provided
Not provided
Will follow the NIH Data Sharing Policy and Implementation Guidance on sharing research resources for research purposes to qualified individuals within the scientific community.
Generally, data will be made available after the primary publications of each study.
The Data Sharing Agreements will be formulated by the study team.
Not provided
31 participants signed a consent which was defined as enrollment in the protocol. 1 participant withdrew after signing the consent due to personal scheduling issues and 30 participants were randomized and reported in study results.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Group 1 | AID + Auto Titration Module (ATM) and Web Simulation Tool (WST) for 6 weeks Web Simulation Tool (WST): WST will allow users of the Control-IQ system replay treatment scenarios in computer simulation, thereby allowing user training with carbohydrate and insulin action. Auto Titration Module (ATM): ATM provides recommendations to the participant to periodically update insulin parameters. Automated Insulin Delivery (AID) System: The t:slim X2 insulin pump with Control-IQ technology, Tandem Diabetes Care will be the AID in this study. |
| FG001 | Group 2 | AID + Auto Titration Module (ATM) and Web Simulation Tool (WST) +Behavioral Adaptation Module (BAM) for 6 weeks Web Simulation Tool (WST): WST will allow users of the Control-IQ system replay treatment scenarios in computer simulation, thereby allowing user training with carbohydrate and insulin action. Behavioral Adaptation Module (BAM): BAM provides on-demand information to the participant primarily on glycemic risks. Auto Titration Module (ATM): ATM provides recommendations to the participant to periodically update insulin parameters. Automated Insulin Delivery (AID) System: The t:slim X2 insulin pump with Control-IQ technology, Tandem Diabetes Care will be the AID in this study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Group 1 | AID + Auto Titration Module (ATM) and Web Simulation Tool (WST) for 6 weeks Web Simulation Tool (WST): WST will allow users of the Control-IQ system replay treatment scenarios in computer simulation, thereby allowing user training with carbohydrate and insulin action. Auto Titration Module (ATM): ATM provides recommendations to the participant to periodically update insulin parameters. Automated Insulin Delivery (AID) System: The t:slim X2 insulin pump with Control-IQ technology, Tandem Diabetes Care will be the AID in this study. |
| 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 | Number of SAE or ADE Related to the Use of ATM / WST and BAM Modules. | Safety assessment of ATM / WST and BAM modules by assessing serious adverse events or adverse device effects deemed related to the use of ATM/WST and BAM modules specifically. | Posted | Number | events | 6 weeks |
|
Duration of study which was approximately 8 weeks.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Group 1 | AID + Auto Titration Module (ATM) and Web Simulation Tool (WST) for 6 weeks Web Simulation Tool (WST): WST will allow users of the Control-IQ system replay treatment scenarios in computer simulation, thereby allowing user training with carbohydrate and insulin action. Auto Titration Module (ATM): ATM provides recommendations to the participant to periodically update insulin parameters. Automated Insulin Delivery (AID) System: The t:slim X2 insulin pump with Control-IQ technology, Tandem Diabetes Care will be the AID in this study. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sue Brown | University of Virginia | 434-982-0602 | sab2f@virginia.edu |
Not provided
| 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 | Jun 30, 2021 | Feb 10, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jul 21, 2021 | Feb 10, 2022 | ICF_001.pdf |
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D007316 | Insemination, Artificial, Heterologous |
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D007315 | Insemination, Artificial |
| D027724 | Reproductive Techniques, Assisted |
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Behavioral Adaptation Module (BAM) | Device | BAM provides on-demand information to the participant primarily on glycemic risks. |
|
| Auto Titration Module (ATM) | Device | ATM provides recommendations to the participant to periodically update insulin parameters. |
|
| Automated Insulin Delivery (AID) System | Device | The t:slim X2 insulin pump with Control-IQ technology, Tandem Diabetes Care will be the AID in this study. |
|
| 6 weeks |
| INSPIRE Questionnaire | Questionnaire addressing system/technology use. 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. | 6 weeks |
| BG001 | Group 2 | AID + Auto Titration Module (ATM) and Web Simulation Tool (WST) +Behavioral Adaptation Module (BAM) for 6 weeks Web Simulation Tool (WST): WST will allow users of the Control-IQ system replay treatment scenarios in computer simulation, thereby allowing user training with carbohydrate and insulin action. Behavioral Adaptation Module (BAM): BAM provides on-demand information to the participant primarily on glycemic risks. Auto Titration Module (ATM): ATM provides recommendations to the participant to periodically update insulin parameters. Automated Insulin Delivery (AID) System: The t:slim X2 insulin pump with Control-IQ technology, Tandem Diabetes Care will be the AID in this study. |
| 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 |
|
| Total Daily Insulin | Mean | Standard Deviation | units per day |
|
| Duration of Diabetes | Mean | Standard Deviation | years |
|
| Group 2 |
AID + Auto Titration Module (ATM) and Web Simulation Tool (WST) +Behavioral Adaptation Module (BAM) for 6 weeks Web Simulation Tool (WST): WST will allow users of the Control-IQ system replay treatment scenarios in computer simulation, thereby allowing user training with carbohydrate and insulin action. Behavioral Adaptation Module (BAM): BAM provides on-demand information to the participant primarily on glycemic risks. Auto Titration Module (ATM): ATM provides recommendations to the participant to periodically update insulin parameters. Automated Insulin Delivery (AID) System: The t:slim X2 insulin pump with Control-IQ technology, Tandem Diabetes Care will be the AID in this study. |
|
|
| Secondary | Time in Range | Percent of CGM readings in the target ranges of 70-180mg/dL from 2 weeks of baseline compared to last 2 weeks of treatment period. | Posted | Mean | Standard Deviation | percentage of time | 6 weeks |
|
|
|
|
| Secondary | Time in Hypoglycemia | Percent of CGM readings <70 mg/dL | Posted | Mean | Standard Deviation | percentage of time | 6 weeks |
|
|
|
|
| Secondary | INSPIRE Questionnaire | Questionnaire addressing system/technology use. 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. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks |
|
|
|
| 0 |
| 15 |
| 0 |
| 15 |
| 0 |
| 15 |
| EG001 | Group 2 | AID + Auto Titration Module (ATM) and Web Simulation Tool (WST) +Behavioral Adaptation Module (BAM) for 6 weeks Web Simulation Tool (WST): WST will allow users of the Control-IQ system replay treatment scenarios in computer simulation, thereby allowing user training with carbohydrate and insulin action. Behavioral Adaptation Module (BAM): BAM provides on-demand information to the participant primarily on glycemic risks. Auto Titration Module (ATM): ATM provides recommendations to the participant to periodically update insulin parameters. Automated Insulin Delivery (AID) System: The t:slim X2 insulin pump with Control-IQ technology, Tandem Diabetes Care will be the AID in this study. | 0 | 15 | 0 | 15 | 0 | 15 |
Not provided
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D008919 | Investigative Techniques |
| D007314 | Insemination |
| D012098 | Reproduction |
| D055703 | Reproductive Physiological Phenomena |
| D012101 | Reproductive and Urinary Physiological Phenomena |
| D004358 | Drug Therapy |
| Superiority |
| Superiority |