AzTrials
AzTrials

Type 1 DiabetesNCT05403502

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

A study of Type 1 Diabetes, run by Tandem Diabetes Care, Inc. at 13 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 6 to 80 years
Conditions the study is for
Type 1 Diabetes
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
183 participants
Where
13 sitesUnited States
Study dates
31 Aug 2022to 2 Aug 2023
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
Show all 15Show fewer
  • 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

Who cannot join

  • 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)
Show all 22Show fewer
  • 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)
  • Significant chronic kidney disease (which could impact CGM accuracy in investigator's judgment) or hemodialysis
  • History of adrenal insufficiency
  • History of abnormal TSH consistent with hypothyroidism or hyperthyroidism that is not appropriately treated
  • History of gastroparesis
  • A condition, which in the opinion of the investigator or designee, would put the participant or study at risk
  • Participation in another pharmaceutical or device trial at the time of enrollment or anticipated for during the time period of study participation
  • Employed by, or having immediate family members employed by Tandem Diabetes Care, Inc., Eli Lilly and Co., 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

Trial locations and contacts

13 sites in 1 country.

13 sites in 1 country

United States13 sites

  • Barbara Davis Center

    Aurora, Colorado, 80045

  • Joslin Diabetes Center

    Boston, Massachusetts, 02215

  • University of Virginia

    Charlottesville, Virginia, 22903

  • Northwestern University

    Evanston, Illinois, 60208

  • University of Florida

    Gainesville, Florida, 32610

  • Indiana University / Riley Hospital for Children

    Indianapolis, Indiana, 46202

  • Children's Mercy Hospital

    Kansas City, Missouri, 64108

  • Icahn School of Medicine at Mt. Sinai

    New York, New York, 10029

  • Children's Hospital Orange County

    Orange, California, 92868

  • Stanford University

    Palo Alto, California, 94304

  • Diabetes & Glandular Disease (DGD)

    San Antonio, Texas, 78229

  • University of South Florida Diabetes Center

    Tampa, Florida, 33612

  • Iowa Diabetes and Endocrinology Research Center (IDERC)

    West Des Moines, Iowa, 50265

Other trials in United States

About this study

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.

Read the detailed description

This is a prospective, multi-center, single-arm study in adults and children (ages 6 to 80 years) with type 1 diabetes who are current users of the t:slim X2 insulin pump with Control-IQ technology to achieve labeling updates for Lyumjev and the t:slim X2 insulin pump. After a run-in period, participants will use the study pump with Control-IQ technology 1.5 and Lyumjev insulin for a 3-month outpatient treatment period. Up to 200 participants will be enrolled so at least 160 complete the study.

Conditions
Type 1 Diabetes
Being tested
t:slim X2 insulin pump with Control-IQ technology 1.5
Keywords
type 1 diabetes, Control-IQ Technology, lyumjev
Medical subject headings
Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

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

Study groups in NCT05403502
Study groupRoleWhat they receive
t:slim X2 insulin pump with Control-IQ technology utilizing insulin Lyumjev®ExperimentalCurrent 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.
Receives: Device: t:slim X2 insulin pump with Control-IQ technology 1.5

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Severe Hypoglycemia

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

    Measured: 15 weeks

  2. Diabetic Ketoacidosis

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

    Measured: 15 weeks

  3. Unanticipated Adverse Device Effects

    Number of unanticipated adverse device effects (UADE) events

    Measured: 15 weeks

Secondary outcomes (4)

  1. Overall Percent Time Less Than 54 mg/dL

    CGM overall percent time less than 54 mg/dL

    Measured: 15 Weeks

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

    CGM postprandial percent time less than 54 mg/dL, through 4 hours after each meal. Calculated as mean (SD) over all 4 hour postprandial periods throughout the study.

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

  3. Overall Percent Time Less Than 70 mg/dL

    CGM overall percent time less than 70 mg/dL

    Measured: 15 weeks

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

    CGM postprandial percent time less than 70 mg/dL, through 4 hours after each meal. Calculated as mean (SD) over all 4 hour postprandial periods throughout the study.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Jun 2022
  2. Study start31 Aug 2022
  3. Primary completion2 Aug 2023
  4. Study completion2 Aug 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
183 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05403502
Sponsor's protocol ID
TP-0009650
Status last verified
Jul 2024
First submitted
19 May 2022
Last updated
26 Jul 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 38696672

Questions about this trial

What is this clinical trial studying?

A study of Type 1 Diabetes, run by Tandem Diabetes Care, Inc. at 13 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 15 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 13 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Jul 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Severe Hypoglycemia (time frame: 15 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05403502, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024; AzTrials last refreshed its copy on 31 Oct 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Keep searching with a free account

You’ve used your 3 free searches for this session. Log in or create a free AzTrials account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in