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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03368937
Other study ID # 20251
Secondary ID UC4DK108483
Status Completed
Phase N/A
First received
Last updated
Start date December 8, 2017
Est. completion date December 11, 2017

Study information

Verified date May 2022
Source University of Virginia
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Completed
Enrollment 5
Est. completion date December 11, 2017
Est. primary completion date December 11, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 74 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

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.

Locations

Country Name City State
United States University of Virginia Center for Diabetes Technology Charlottesville Virginia

Sponsors (4)

Lead Sponsor Collaborator
University of Virginia DexCom, Inc., National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), Tandem Diabetes Care, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary System Suitability 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. 36-48 hours
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