Safety Evaluation of an Advanced Hybrid Closed Loop System Using Lyumjev With the Tandem t:Slim X2 Insulin Pump With Control-IQ Technology in Adults, Adolescents and Children With Type 1 Diabetes

NCT05403502 | Completed Results FDA Device

• 1 other identifier: TP-0009650
• Study Type: interventional
• Target: 183
• Locations: 1 country
• Sites: 13

Brief Summary

Prospective, multi-center, single-arm study in adults and children ages 6 to 80 with type 1 diabetes to evaluate the safety of Lyumjev with Control-IQ technology to achieve labeling updates for Lyumjev and the t:slim X2 insulin pump.

Conditions

Type 1 Diabetes

Keywords

type 1 diabetes; Control-IQ Technology; lyumjev

Outcome Measures

Primary Outcomes (3)

• Severe Hypoglycemia

  Number of severe hypoglycemia events (with cognitive impairment such that assistance of another individual is needed for treatment) during study

  15 weeks

• Diabetic Ketoacidosis

  Number of diabetic ketoacidosis events requiring an overnight hospitalization and diagnosis by a doctor.

  15 weeks

• Unanticipated Adverse Device Effects

  Number of unanticipated adverse device effects (UADE) events

  15 weeks

Secondary Outcomes (4)

• Overall Percent Time Less Than 54 mg/dL

  15 Weeks

• Postprandial Percent Time Less Than 54 mg/dL, Through 4 Hours After Each Meal

  during 4 hour postprandial period after each meal, up to 15 weeks

• Overall Percent Time Less Than 70 mg/dL

  15 weeks

• Postprandial Percent Time Less Than 70 mg/dL, Through 4 Hours After Each Meal

  during 4 hour postprandial period after each meal, up to 15 weeks

Other Outcomes (40)

• Overall Percent Time in Range Between 70-180 mg/dL

  15 weeks

• Percent Time in Range Between 70-180 mg/dL, Daytime Only (6:00 AM - 11:59 PM)

  15 weeks

• Percent Time in Range Between 70-180 mg/dL, Nighttime Only (12:00 AM - 5:59 AM)

  15 weeks

Study Arms (1)

t:slim X2 insulin pump with Control-IQ technology utilizing insulin Lyumjev®

EXPERIMENTAL

Current Control-IQ technology users with type 1 diabetes, age 6-80, will use the t:slim X2 insulin pump with Control-IQ technology 1.5 and Lyumjev insulin for 3-months of outpatient use.

Device: t:slim X2 insulin pump with Control-IQ technology 1.5

Interventions

t:slim X2 insulin pump with Control-IQ technology 1.5 DEVICE

t:slim X2 insulin pump with Control-IQ technology 1.5, and wearing the Dexcom G6 sensor, used with Lyumjev® insulin.

t:slim X2 insulin pump with Control-IQ technology utilizing insulin Lyumjev®

Eligibility Criteria

• Age: 6 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 6 to \<81 years
• Diagnosis of type 1 diabetes for at least 1 year
• Currently using Control-IQ technology for at least 3 months, with CGM data recorded indicative of system use (active closed loop) for at least 85% of the possible time in 14 days prior to enrollment
• Total daily insulin dose (TDD) at least 2 U/day
• HbA1c \< 10.5%
• Residing full-time in the United States, with no anticipated travel outside the United States during the period of study participation.
• For participants \<18 years old, living with one or more parent/legal guardian knowledgeable about emergency procedures for severe hypoglycemia and able to contact the participant in case of an emergency, and willing to use the Dexcom Follow app (with push notifications turned on) for the duration of the study.
• If \>18 years old, participant has someone who lives within 30 minutes of them who is willing to be contacted if the study team can't reach the participant in case of a suspected medical emergency.
• Participant has agreed to participate in the study; and has read, understood and signed the informed consent form (ICF) and assent, if applicable; and has agreed to follow all study procedures, including:
• suspending use of any personal CGM for the duration of the clinical trial once the study CGM is in use
• switching to or continuing to use Humalog during the lead-in period
• switching to Lyumjev for the main study period.
• willing and able to perform the study exercise and meal challenges.
• Investigator has confidence that the participant can successfully operate all study devices and is capable of adhering to the protocol, including ability to respond to alerts and alarms, and to provide basic diabetes self-management.
• Participant and/or parent/legal guardian have the ability to read and understand English

You may not qualify if:

• More than 1 episode of diabetic ketoacidosis (DKA) in the past 6 months
• More than 1 episode of severe hypoglycemia (needing assistance) in the past 6 months
• Inpatient psychiatric treatment in the past 6 months
• History of drug abuse (defined as any illicit drug use) or history of alcohol abuse prior to screening or unwillingness to agree to abstain from illicit drugs throughout the study.
• For Female: Currently pregnant or planning to become pregnant during the time period of study participation
• A negative pregnancy test will be required for all females of child-bearing potential (menarchal)
• Counseling on appropriate birth control options will be provided to females with child-bearing potential in the event the participant does not have an acceptable plan.
• Adults lacking the capacity to provide consent and/or follow study procedures in the opinion of the investigator
• Concurrent use of any non-insulin glucose-lowering agent, other than metformin (for example, GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, sulfonylureas).
• Hemophilia or any other bleeding disorder
• Hemoglobinopathy
• History of heart, liver, lung or kidney disease determined by investigator to interfere with the study
• History of allergic reaction to Humalog or Lyumjev
• Use of glucocorticoids, beta blockers or other medications determined by investigator to interfere with study
• Abnormal screening electrocardiogram consistent with increased risk during exercise, such as arrhythmia, ischemia, or prolonged QTc interval (\>450 ms) (Screening ECG only required for participants age \> 50 years, duration of diabetes \> 20 years, or history of coronary artery disease)

Sponsors & Collaborators

• Tandem Diabetes Care, Inc.: lead
• Eli Lilly and Company: collaborator
• Jaeb Center for Health Research: collaborator

Study Sites (13)

Children's Hospital Orange County

Orange, California, 92868, United States

Location

Stanford University

Palo Alto, California, 94304, United States

Location

Barbara Davis Center

Aurora, Colorado, 80045, United States

Location

University of Florida

Gainesville, Florida, 32610, United States

Location

University of South Florida Diabetes Center

Tampa, Florida, 33612, United States

Location

Northwestern University

Evanston, Illinois, 60208, United States

Location

Indiana University / Riley Hospital for Children

Indianapolis, Indiana, 46202, United States

Location

Iowa Diabetes and Endocrinology Research Center (IDERC)

West Des Moines, Iowa, 50265, United States

Location

Joslin Diabetes Center

Boston, Massachusetts, 02215, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

Icahn School of Medicine at Mt. Sinai

New York, New York, 10029, United States

Location

Diabetes & Glandular Disease (DGD)

San Antonio, Texas, 78229, United States

Location

University of Virginia

Charlottesville, Virginia, 22903, United States

Location

Related Publications (1)

• Levy CJ, Bailey R, Laffel LM, Forlenza G, DiMeglio LA, Hughes MS, Brown SA, Aleppo G, Bhargava A, Shah VN, Clements MA, Kipnes M, Bruggeman B, Daniels M, Rodriguez H, Calhoun P, Lum JW, Sasson-Katchalski R, Pinsker JE, Pollom R, Beck RW; TL1 Study Group. Multicenter Evaluation of Ultra-Rapid Lispro Insulin with Control-IQ Technology in Adults, Adolescents, and Children with Type 1 Diabetes. Diabetes Technol Ther. 2024 Sep;26(9):652-660. doi: 10.1089/dia.2024.0048. Epub 2024 May 22.

  PMID: 38696672 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Sr. Supervisor of Clinical Operations
• Organization: Tandem Diabetes Care

clinicalaffairs@tandemdiabetes.com

+18583666900

Study Officials

• Jordan Pinsker, MD

  Tandem Diabetes Care

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2022
• First Posted: June 3, 2022
• Study Start: August 31, 2022
• Primary Completion: August 2, 2023
• Study Completion: August 2, 2023
• Last Updated: July 26, 2024
• Results First Posted: July 26, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (13)