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

NCT ID: NCT03368937

Last Updated: 2022-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-08
• Study Completion Date: 2017-12-11

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.

Conditions

Type1 Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Tandem t:slim X2 with Control-IQ Technology

Intervention Type: DEVICE

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

Interventions

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.

Intervention Type: DEVICE

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 74 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tandem Diabetes Care, Inc.

INDUSTRY

Sponsor Role: collaborator

DexCom, Inc.

INDUSTRY

Sponsor Role: collaborator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Sue Brown

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sue A Brown, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia Center for Diabetes Technology

Locations

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 30305346 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

UC4DK108483

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20251

Identifier Type: -

Identifier Source: org_study_id