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

NCT04084171 | Completed Results FDA Device

• 1 other identifier: 190031
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 3

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

Conditions

Type 1 Diabetes

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Primary Outcome

  Percentage of subjects with less than 6% time below 70mg/dL and less than 40% time above 180mg/dL.

  Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.

Secondary Outcomes (14)

• Below 70 mg/dl.

  Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.

• Below 60 mg/dl.

  Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.

• Below 54 mg/dl.

  Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.

• Below 50mg/dl.

  Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.

• Above 180 mg/dl.

  Baseline results are from the 2-7 day (median of 4 day) use of Open Loop before the hotel admission. AP results are from the 5 day study admission using Control IQ including 48 hours of supervised hotel admission followed by 72 hours at home.

Study Arms (1)

Artificial Pancreas Therapy

EXPERIMENTAL

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

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

Interventions

Tandem t:slim X2 with Control-IQ Technology + Dexcom G6 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 \[CGM\].

Also known as: Artificial Pancreas, Automated Insulin Delivery Device

Artificial Pancreas Therapy

Eligibility Criteria

• Age: 2 Years - 6 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Age ≥ 2 and \< 6 years old at the time of consent
• Clinical diagnosis, based on investigator assessment, of type 1 diabetes for at least 3 months and using insulin at the time of enrollment
• Use of an insulin pump in the past 3 months
• Use of Dexcom G6 for at least 11 out of the last 14 days
• Parent/guardian(s) have familiarity with and use of carbohydrate ratios for meal boluses
• Living with one or more parent/guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact emergency services and study staff
• 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
• Investigator has confidence that the parent/guardian(s) can successfully operate all study devices and is capable of adhering to the protocol
• 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
• Total daily insulin dose (TDD) of at least 5 U/day
• Willingness not to start any new non-insulin glucose-lowering agent during the course of the trial
• Child participant and parent/guardian(s) willingness to participate in all training sessions as directed by study staff
• Willingness to discontinue non-Tandem t:slim insulin pumps during the entire study
• Willingness to wear a Dexcom G6 sensor during the entire study
• An understanding and willingness to follow the protocol and sign informed consent

You may not qualify if:

• Hypoglycemia induced seizure or loss of consciousness in the past 3 months
• Diabetes Ketoacidosis in the past 3 months
• Use of diluted insulin
• Concurrent use of any non-insulin glucose-lowering agent
• Hemophilia or any other bleeding disorder
• 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
• Participation in another pharmaceutical or device trial at the time of enrollment or during the study.
• 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.

Sponsors & Collaborators

• University of Virginia: lead
• DexCom, Inc.: collaborator
• Tandem Diabetes Care, Inc.: collaborator

Study Sites (3)

Stanford University

Stanford, California, 94304, United States

Location

Barbara Davis Center, University of Colorado

Aurora, Colorado, 80045, United States

Location

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, 22903, United States

Location

Related Publications (1)

• 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.

  PMID: 33226837 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Pancreas, Artificial

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Artificial Organs; Surgical Equipment; Equipment and Supplies

Limitations and Caveats

Short term study in a limited number of individuals significantly limits the generalization of the results to clinical care

Results Point of Contact

• Title: Marc Breton, PhD
• Organization: University of Virginia Center for Diabetes Technology

mb6nt@virginia.edu

434-982-6484

Study Officials

• Marc Breton, PhD

  University of Virginia Center for Diabetes Technology

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: Associate Professor

Study Record Dates

• First Submitted: September 6, 2019
• First Posted: September 10, 2019
• Study Start: September 26, 2019
• Primary Completion: October 23, 2019
• Study Completion: October 23, 2019
• Last Updated: March 22, 2023
• Results First Posted: March 22, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After manuscript publication

Locations

US (3)