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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
Sponsor:
Collaborators:
Tandem Diabetes Care, Inc.
DexCom, Inc.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Sue Brown, University of Virginia

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Other
Condition Type1 Diabetes Mellitus
Intervention Device: Tandem t:slim X2 with Control-IQ Technology
Enrollment 5
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Tandem t:Slim X2 With Control-IQ Technology
Hide Arm/Group Description

Subjects will use the Tandem t:slim X2 with Control-IQ Technology during a 36-48 hour hotel admission.

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.

Period Title: Overall Study
Started 5
Completed 5
Not Completed 0
Arm/Group Title Tandem t:Slim X2 With Control-IQ Technology
Hide Arm/Group Description

Subjects will use the Tandem t:slim X2 with Control-IQ Technology during a 36-48 hour hotel admission.

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.

Overall Number of Baseline Participants 5
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 5 participants
52.8  (15.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
Female
3
  60.0%
Male
2
  40.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 5 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
5
 100.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 5 participants
5
1.Primary Outcome
Title System Suitability
Hide Description 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.
Time Frame 36-48 hours
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tandem t:Slim X2 With Control-IQ Technology
Hide Arm/Group Description:

Subjects will use the Tandem t:slim X2 with Control-IQ Technology during a 36-48 hour hotel admission.

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.

Overall Number of Participants Analyzed 5
Mean (Full Range)
Unit of Measure: score on a scale
Ease of Use
5
(5 to 5)
Usefulness
4.8
(4 to 5)
Trust in System
5
(5 to 5)
Time Frame 48 hours
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Tandem t:Slim X2 With Control-IQ Technology
Hide Arm/Group Description

Subjects will use the Tandem t:slim X2 with Control-IQ Technology during a 36-48 hour hotel admission.

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.

All-Cause Mortality
Tandem t:Slim X2 With Control-IQ Technology
Affected / at Risk (%)
Total   0/5 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Tandem t:Slim X2 With Control-IQ Technology
Affected / at Risk (%)
Total   0/5 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Tandem t:Slim X2 With Control-IQ Technology
Affected / at Risk (%)
Total   0/5 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Sue Brown
Organization: University of Virginia
Phone: 434-982-0206
EMail: sab2f@virginia.edu
Layout table for additonal information
Responsible Party: Sue Brown, University of Virginia
ClinicalTrials.gov Identifier: NCT03368937     History of Changes
Other Study ID Numbers: 20251
UC4DK108483 ( U.S. NIH Grant/Contract )
First Submitted: November 29, 2017
First Posted: December 11, 2017
Results First Submitted: February 1, 2019
Results First Posted: February 27, 2019
Last Update Posted: February 27, 2019