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

NCT03368937 | Completed Results DMC FDA Device

• 2 other identifiers: 20251UC4DK108483
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Type1 Diabetes Mellitus

Keywords

Artificial Pancreas (AP); Closed Loop Control (CLC); Continuous Glucose Monitor (CGM); Insulin Pump

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Tandem t:slim X2 with Control-IQ Technology

EXPERIMENTAL

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

Interventions

Tandem t:slim X2 with Control-IQ Technology DEVICE

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

Tandem t:slim X2 with Control-IQ Technology

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible for the study, a subject must meet the following criteria:
• Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least one year and using insulin for at least 1 year
• 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.
• Age 18.0 to \<75.0 years
• Hemoglobin A1c \<10.5%
• 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.
• Willingness to suspend use of any personal CGM for the duration of the clinical trial once the study CGM is in use
• Investigator has confidence that the subject can successfully operate all study devices and is capable of adhering to the protocol
• 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).
• Total daily insulin dose (TDD) at least 10 U/day and ≤100 U/day
• Weight at least 25 kg and not greater than 140 kg

You may not qualify if:

• More than one episode of diabetic ketoacidosis (DKA) in the 6 months prior to enrollment
• More than one episode of severe hypoglycemia involving seizure or loss of consciousness in the 6 months prior to enrollment
• Concurrent use of any non-insulin glucose-lowering agent (including GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, biguanides, sulfonylureas and naturaceuticals).
• Hemophilia or any other bleeding disorder
• A condition, which in the opinion of the investigator or designee, would put the subject or study at risk
• Participation in another pharmaceutical or device trial at the time of enrollment or during the study
• 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

Sponsors & Collaborators

• University of Virginia: lead
• Tandem Diabetes Care, Inc.: collaborator
• DexCom, Inc.: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, 22903, United States

Location

Related 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.

  PMID: 30305346 RESULT

Results Point of Contact

• Title: Sue Brown
• Organization: University of Virginia

sab2f@virginia.edu

434-982-0206

Study Officials

• Sue A Brown, MD

  University of Virginia Center for Diabetes Technology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 29, 2017
• First Posted: December 11, 2017
• Study Start: December 8, 2017
• Primary Completion: December 11, 2017
• Study Completion: December 11, 2017
• Last Updated: May 25, 2022
• Results First Posted: February 27, 2019

Record last verified: 2022-05

Locations

US (1)