A Pilot Test of t:Slim X2 With Control-IQ Technology
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03368937|
Recruitment Status : Completed
First Posted : December 11, 2017
Results First Posted : February 27, 2019
Last Update Posted : February 27, 2019
|Condition or disease||Intervention/treatment||Phase|
|Type1 Diabetes Mellitus||Device: Tandem t:slim X2 with Control-IQ Technology||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||5 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas - A Pilot Test of t:Slim X2 With Control-IQ Technology|
|Actual Study Start Date :||December 8, 2017|
|Actual Primary Completion Date :||December 11, 2017|
|Actual Study Completion Date :||December 11, 2017|
Experimental: Tandem t:slim X2 with Control-IQ Technology
Subjects will use the Tandem t:slim X2 with Control-IQ Technology during a 36-48 hour hotel admission.
Device: Tandem t:slim X2 with Control-IQ Technology
Subjects will wear the Tandem t:slim X2 with Control-IQ Technology during a 36-48 hour hotel admission.
- System Suitability [ Time Frame: 36-48 hours ]Technology Acceptance Questionnaire Score Scores are on a Likert Scale of 1-Not at All to 5-Extremely for Ease of Use, Usability and Trust in System Scores.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03368937
|United States, Virginia|
|University of Virginia Center for Diabetes Technology|
|Charlottesville, Virginia, United States, 22903|
|Principal Investigator:||Sue A Brown, MD||University of Virginia Center for Diabetes Technology|