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Insulin Pump

t:slim X2 insulin pump with Control-IQ technology 1.5 for Type 1 Diabetes

N/A
Waitlist Available
Research Sponsored by Tandem Diabetes Care, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Diagnosis of type 1 diabetes for at least 1 year
switching to Lyumjev for the main study period.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months
Awards & highlights

Study Summary

This trial looks at how safe and effective Lyumjev is for people with type 1 diabetes.

Eligible Conditions
  • Type 1 Diabetes

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
You have been diagnosed with type 1 diabetes for at least one year.
Select...
You will be using Lyumjev for the entire study duration.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adverse drug reactions
Diabetic ketoacidosis
Other serious adverse events
+2 more
Secondary outcome measures
All reportable adverse events
CGM hypoglycemia outcomes: Overall % time <54 mg/dL
CGM hypoglycemia outcomes: Overall % time <70 mg/dL
+3 more
Other outcome measures
CGM metrics for glucose variability by time of day
CGM metrics for time in hyperglycemia by time of day
CGM metrics for time in hypoglycemia by time of day
+14 more

Side effects data

From 2016 Phase 4 trial • 85 Patients • NCT01970241
21%
Hypoglycemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
NPH With Corticosteroid
Control

Trial Design

1Treatment groups
Experimental Treatment
Group I: t:slim X2 insulin pump with Control-IQ technology utilizing insulin Lyumjev®Experimental Treatment1 Intervention
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
t:slim X2 insulin pump with Control-IQ technology 1.5
2022
N/A
~220

Find a Location

Who is running the clinical trial?

Tandem Diabetes Care, Inc.Lead Sponsor
37 Previous Clinical Trials
5,504 Total Patients Enrolled
Eli Lilly and CompanyIndustry Sponsor
2,613 Previous Clinical Trials
3,200,746 Total Patients Enrolled
Jaeb Center for Health ResearchOTHER
152 Previous Clinical Trials
34,551 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for this study open to those over 25 years of age?

"The minimum age for entry into this trial is 6 years and the maximum age is 80, as stated in its inclusion criteria."

Answered by AI

What are the requisite qualifications for entry into this medical trial?

"This research project is currently recruiting 200 individuals diagnosed with diabetes mellitus, aged between 6 and 80. In addition to this requirement, participants must demonstrate a total daily insulin dose of at least 2 units per day; have an HbA1c level below 10.5%; be living in the United States full-time, without any planned international travel during the period of study participation; those under 18 years old need to reside with one or more parent/legal guardian who are knowledgeable about emergency procedures for severe hypoglycemia and can contact them in case of an emergency; if over 18 years old they must have someone within 30 minutes that"

Answered by AI

Is the enrollment period for this research still accepting participants?

"Affirmative. According to the information on clinicaltrials.gov, this study is recruiting participants as of now - it was initially posted August 31st 2022 and edited most recently November 30th 2022. Two hundred individuals need to be enrolled from 14 distinct sites."

Answered by AI

To what extent are medical facilities participating in this clinical investigation?

"Currently, fourteen sites are onboard for this clinical trial. Examples include Stanford University of Palo Alto, Diabetes & Glandular Disease (DGD) in San Antonio and the University of California at San Francisco. There is an additional eleven locations to boot."

Answered by AI

What results is this investigation hoping to produce?

"For this study, the primary measure of success over a three-month period is assessing severe hypoglycemia. Additionally, secondary objectives include gauging postprandial and overall percent time spent at levels lower than 70 mg/dL or 54 mg/dL respectively using continuous glucose monitoring (CGM)."

Answered by AI

How many individuals are volunteering in this experiment?

"That is accurate. Clinicaltrials.gov indicates that the trial, which commenced on August 31st 2022, is actively recruiting participants and seeks to enrol 200 individuals across 14 different sites."

Answered by AI

Who else is applying?

What state do they live in?
Texas
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
~71 spots leftby Apr 2025