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

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Children's Hospital Orange County, Orange, CA
Diabetes Mellitus+2 More
t:slim X2 insulin pump with Control-IQ technology 1.5 - Device
Eligibility
Any Age
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions

  • Diabetes Mellitus
  • Type 1 Diabetes Mellitus

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Diabetes Mellitus

Study Objectives

5 Primary · 6 Secondary · Reporting Duration: 3 months

3 months
Adverse drug reactions
All reportable adverse events
CGM hypoglycemia outcomes: Overall % time <54 mg/dL
CGM hypoglycemia outcomes: Overall % time <70 mg/dL
CGM hypoglycemia outcomes: Postprandial % time <54 mg/dL
CGM hypoglycemia outcomes: Postprandial % time <70 mg/dL
CGM hypoglycemia outcomes: Rate of hypoglycemia events
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
CGM metrics for time in range by time of day
Diabetic ketoacidosis
HbA1c change from baseline
Mean glucose
Other serious adverse events
Overall variability (Coefficient of Variation and Standard Deviation)
Patient Reported Outcomes: ITSQ
Patient Reported Outcomes: TRIM-D
Patient Reported Outcomes: TRIM-DD
Rate of hyperglycemia events
Severe hypoglycemia
Time in range - overall and postprandial 70-180 mg/dL
Time in range - overall and postprandial >180 mg/dL
Time in range - overall and postprandial >250 mg/dL
Times in range - overall and postprandial 70-140 mg/dL
Unanticipated adverse device effects
4 hours
Peak postprandial glucose
Postprandial incremental area under the glucose curve

Trial Safety

Safety Progress

1 of 3

Other trials for Diabetes Mellitus

Trial Design

1 Treatment Group

t:slim X2 insulin pump with Control-IQ technology utilizing insulin Lyumjev®
1 of 1
Experimental Treatment

200 Total Participants · 1 Treatment Group

Primary Treatment: t:slim X2 insulin pump with Control-IQ technology 1.5 · No Placebo Group · N/A

t:slim X2 insulin pump with Control-IQ technology utilizing insulin Lyumjev®
Device
Experimental Group · 1 Intervention: t:slim X2 insulin pump with Control-IQ technology 1.5 · Intervention Types: Device

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: 3 months
Closest Location: Children's Hospital Orange County · Orange, CA
Photo of Orange 1Photo of Orange 2Photo of Orange 3
2022First Recorded Clinical Trial
2 TrialsResearching Diabetes Mellitus
7 CompletedClinical Trials

Who is running the clinical trial?

Tandem Diabetes Care, Inc.Lead Sponsor
32 Previous Clinical Trials
3,789 Total Patients Enrolled
17 Trials studying Diabetes Mellitus
1,042 Patients Enrolled for Diabetes Mellitus
Jaeb Center for Health ResearchOTHER
138 Previous Clinical Trials
29,990 Total Patients Enrolled
42 Trials studying Diabetes Mellitus
6,791 Patients Enrolled for Diabetes Mellitus
Eli Lilly and CompanyIndustry Sponsor
2,427 Previous Clinical Trials
3,102,243 Total Patients Enrolled
354 Trials studying Diabetes Mellitus
687,155 Patients Enrolled for Diabetes Mellitus
Jordan Pinsker, MDStudy DirectorTandem Diabetes Care
8 Previous Clinical Trials
2,280 Total Patients Enrolled
3 Trials studying Diabetes Mellitus
116 Patients Enrolled for Diabetes Mellitus

Eligibility Criteria

Age Any Age · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
If you are aged 6 to <81 years, you have a positive screening test.
You have type 1 diabetes for at least 1 year.
You are 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.
You are a resident of the United States, with no anticipated travel outside the United States during the period of study participation.
The clinical trial is in use.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.