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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
Last Update Posted : May 24, 2018
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

Brief Summary:
A 36-48 hour admission testing the t:slim X2 with Control-IQ Technology

Condition or disease Intervention/treatment Phase
Type1 Diabetes Mellitus Device: Tandem t:slim X2 with Control-IQ Technology Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. System suitability [ Time Frame: 36-48 hours ]
    Technology Acceptance Questionnaire Score



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 74 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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


Locations
United States, Virginia
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States, 22903
Sponsors and Collaborators
University of Virginia
Tandem Diabetes Care, Inc.
DexCom, Inc.
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Sue A Brown, MD University of Virginia Center for Diabetes Technology

Responsible Party: Sue Brown, Principal Investigator, University of Virginia
ClinicalTrials.gov Identifier: NCT03368937     History of Changes
Other Study ID Numbers: 20251
UC4DK108483 ( U.S. NIH Grant/Contract )
First Posted: December 11, 2017    Key Record Dates
Last Update Posted: May 24, 2018
Last Verified: May 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by Sue Brown, University of Virginia:
Artificial Pancreas (AP)
Closed Loop Control (CLC)
Continuous Glucose Monitor (CGM)
Insulin Pump

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases