Safety of Artificial Pancreas Therapy in Preschoolers, Age 2-6

NCT ID: NCT04084171

Last Updated: 2023-03-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-09-26
• Study Completion Date: 2019-10-23

Brief Summary

A single-arm, multi-center, clinical study to assess the safety profile of the Tandem t:slim X2 with Control-IQ system in children with T1D aged 2-6 years old under free living condition

Detailed Description

This clinical trial aims to demonstrate the safety of the Closed-Loop Control (CLC), also known as Artificial Pancreas (AP) named t:slim X2 with Control-IQ Technology and assess usability in a supervised setting for the treatment of type 1 diabetes (T1D) in young children (2-6 years old).

Conditions

Type 1 Diabetes

Study Design

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

Study Groups

Artificial Pancreas Therapy

Subjects will use the Tandem t:slim X2 with Control-IQ Technology + Dexcom G6 to automatically modulate their insulin delivery and control their glycemia.

Group Type: EXPERIMENTAL

Tandem t:slim X2 with Control-IQ Technology + Dexcom G6

Intervention Type: DEVICE

Subjects will use the Tandem t:slim X2 with Control- IQ Technology and Dexcom G6 CGM to control their glycemia. The Tandem t:slim X2 with Control-IQ device is an automated insulin delivery pump that automatically adjusts insulin delivery to predicted and prevailing glucose levels, as measured by a Dexcom G6 continuous glucose monitor \[CGM\].

Interventions

Tandem t:slim X2 with Control-IQ Technology + Dexcom G6

Subjects will use the Tandem t:slim X2 with Control- IQ Technology and Dexcom G6 CGM to control their glycemia. The Tandem t:slim X2 with Control-IQ device is an automated insulin delivery pump that automatically adjusts insulin delivery to predicted and prevailing glucose levels, as measured by a Dexcom G6 continuous glucose monitor \[CGM\].

Intervention Type: DEVICE

Other Intervention Names

Artificial Pancreas; Automated Insulin Delivery Device

Eligibility Criteria

Inclusion Criteria

1. Age ≥ 2 and < 6 years old at the time of consent

2. Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least 3 months and using insulin at the time of enrollment

3. Use of an insulin pump in the past 3 months

4. Use of Dexcom G6 for at least 11 out of the last 14 days

5. Parent/guardian(s) have familiarity with and use of carbohydrate ratios for meal boluses

6. Living with one or more parent/guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff

7. At least one parent/guardian is willing to stay with the child during the hotel/house portion of the study on the dates selected by the study team

8. Investigator has confidence that the parent/guardian(s) can successfully operate all study devices and is capable of adhering to the protocol

9. Willingness to switch to lispro (Humalog) or aspart (Novolog) if not already, and to use no other insulin besides lispro (Humalog) or aspart (Novolog) during the study

10. Total daily insulin dose (TDD) of at least 5 U/day

11. Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial

12. Child participant and parent/guardian(s) willingness to participate in all training sessions as directed by study staff

13. Willingness to discontinue non-Tandem t:slim insulin pumps during the entire study

14. Willingness to wear a Dexcom G6 sensor during the entire study

15. An understanding and willingness to follow the protocol and sign informed consent

Exclusion Criteria

1. Hypoglycemia induced seizure or loss of consciousness in the past 3 months

2. Diabetes Ketoacidosis in the past 3 months

3. Use of diluted insulin

4. Concurrent use of any non-insulin glucose-lowering agent

5. Hemophilia or any other bleeding disorder

6. A condition, which in the opinion of the investigator or designee, would put the participant or study at risk. These conditions may include:

• Acute illness at the time of the enrollment visit (fever of 101 or higher, vomiting, diarrhea)
• Addison's disease
• Diagnosed at less than 1 year of age without positive antibodies
• Decreased renal function
• Cystic fibrosis
• Other chronic conditions, such as an underlying seizure disorder

7. Participation in another pharmaceutical or device trial at the time of enrollment or during the study.

8. Having a family member(s) employed by Tandem Diabetes Care, Inc. 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: 2 Years
• Maximum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

DexCom, Inc.

INDUSTRY

Sponsor Role: collaborator

Tandem Diabetes Care, Inc.

INDUSTRY

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Marc Breton

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marc Breton, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia Center for Diabetes Technology

Locations

Stanford University

Stanford, California, United States

Barbara Davis Center, University of Colorado

Aurora, Colorado, United States

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, United States

Countries

United States

References

Ekhlaspour L, Schoelwer MJ, Forlenza GP, DeBoer MD, Norlander L, Hsu L, Kingman R, Boranian E, Berget C, Emory E, Buckingham BA, Breton MD, Wadwa RP. Safety and Performance of the Tandem t:slim X2 with Control-IQ Automated Insulin Delivery System in Toddlers and Preschoolers. Diabetes Technol Ther. 2021 May;23(5):384-391. doi: 10.1089/dia.2020.0507. Epub 2020 Dec 8.

Reference Type: RESULT

PMID: 33226837 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

190031

Identifier Type: -

Identifier Source: org_study_id