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A Pilot Test of t:Slim X2 With Control-IQ Technology

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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

Tracking Information
First Submitted Date  ICMJE November 29, 2017
First Posted Date  ICMJE December 11, 2017
Results First Submitted Date  ICMJE February 1, 2019
Results First Posted Date  ICMJE February 27, 2019
Last Update Posted Date February 27, 2019
Actual Study Start Date  ICMJE December 8, 2017
Actual Primary Completion Date December 11, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 8, 2017)
System Suitability [ Time Frame: 36-48 hours ]
Technology Acceptance Questionnaire Score
Change History Complete list of historical versions of study NCT03368937 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Test of t:Slim X2 With Control-IQ Technology
Official Title  ICMJE The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas - A Pilot Test of t:Slim X2 With Control-IQ Technology
Brief Summary A 36-48 hour admission testing the t:slim X2 with Control-IQ Technology
Detailed Description The objective of the study is for clinical staff to gain experience using the proposed artificial pancreas system named t:slim X2 with Control-IQ Technology and assess usability in a supervised setting prior to initiating home use in a Training protocol.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Type1 Diabetes Mellitus
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Device: Tandem t:slim X2 with Control-IQ Technology
Publications * Brown S, Raghinaru D, Emory E, Kovatchev B. First Look at Control-IQ: A New-Generation Automated Insulin Delivery System. Diabetes Care. 2018 Dec;41(12):2634-2636. doi: 10.2337/dc18-1249. Epub 2018 Oct 10.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 23, 2018)
5
Original Estimated Enrollment  ICMJE
 (submitted: December 8, 2017)
20
Actual Study Completion Date  ICMJE December 11, 2017
Actual Primary Completion Date December 11, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

To be eligible for the study, a subject must meet the following criteria:

  1. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year
  2. Use of an insulin pump for at least 6 months with established parameters for basal rate(s), carbohydrate ratio(s) and insulin sensitivity factor(s) for at least 3 months.
  3. Age 18.0 to <75.0 years
  4. Hemoglobin A1c <10.5%
  5. For females, not currently known to be pregnant If female and sexually active, must agree to use a form of contraception to prevent pregnancy while a subject in the study. A negative serum or urine pregnancy test will be required for all premenopausal women who are not surgically sterile. Subjects who become pregnant will be discontinued from the study. Also, subjects who during the study develop and express the intention to become pregnant within the timespan of the study will be discontinued.
  6. Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use
  7. Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol
  8. Currently using no insulins other than one of the following rapid-acting insulins at the time of enrollment: insulin lispro (Humalog), insulin aspart (Novolog), or insulin glulisine (Apidra). Willingness to switch to lispro (Humalog) or aspart (Novolog) if using glulisine (Apidra).
  9. Total daily insulin dose (TDD) at least 10 U/day and ≤100 U/day
  10. Weight at least 25 kg and not greater than 140 kg

Exclusion Criteria:

  1. More than one episode of diabetic ketoacidosis (DKA) in the 6 months prior to enrollment
  2. More than one episode of severe hypoglycemia involving seizure or loss of consciousness in the 6 months prior to enrollment
  3. Concurrent use of any non-insulin glucose-lowering agent (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals).
  4. Hemophilia or any other bleeding disorder
  5. A condition, which in the opinion of the investigator or designee, would put the subject or study at risk
  6. Participation in another pharmaceutical or device trial at the time of enrollment or during the study
  7. Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc. or TypeZero Technologies, LLC, or having a direct supervisor at place of employment who is also directly involved in conducting the clinical trial (as a study investigator, coordinator, etc.); or having a first-degree relative who is directly involved in conducting the clinical trial
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 74 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03368937
Other Study ID Numbers  ICMJE 20251
UC4DK108483 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Sue Brown, University of Virginia
Study Sponsor  ICMJE University of Virginia
Collaborators  ICMJE
  • Tandem Diabetes Care, Inc.
  • DexCom, Inc.
  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators  ICMJE
Principal Investigator: Sue A Brown, MD University of Virginia Center for Diabetes Technology
PRS Account University of Virginia
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP