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

The International Diabetes Closed Loop (iDCL) Trial: Clinical Acceptance of the Artificial Pancreas - A Pilot Test of t:Slim X2 With Control-IQ Technology

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

Study Overview

• Status: Completed
• Conditions: Type1 Diabetes Mellitus
• Intervention / Treatment: Device: Tandem 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: Interventional
• Enrollment (Actual): 5
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22903
      • University of Virginia Center for Diabetes Technology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Virginia
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); DexCom, Inc.; Tandem Diabetes Care, Inc.
• Investigators: Principal Investigator: Sue A Brown, MD, University of Virginia Center for Diabetes Technology

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 8, 2017
• Primary Completion (Actual): December 11, 2017
• Study Completion (Actual): December 11, 2017

Study Registration Dates

• First Submitted: November 29, 2017
• First Submitted That Met QC Criteria: December 8, 2017
• First Posted (Actual): December 11, 2017

Study Record Updates

• Last Update Posted (Actual): May 25, 2022
• Last Update Submitted That Met QC Criteria: May 3, 2022
• Last Verified: May 1, 2022

More Information

Terms related to this study

• Keywords: Artificial Pancreas (AP); Continuous Glucose Monitor (CGM); Closed Loop Control (CLC); Insulin Pump
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 20251; UC4DK108483 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes