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Device

Control-IQ 2.0 Alternate Target 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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Awards & highlights

Study Summary

This trial will test a new tech to help people with type 1 diabetes manage their blood sugar safely and effectively.

Eligible Conditions
  • Type 1 Diabetes

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of diabetic ketoacidosis (DKA) events
Number of other serious device-related adverse events
Number of severe hypoglycemic events
+1 more
Secondary outcome measures
All device-related adverse events
CGM metrics for time in range by time of day
Coefficient of variation
+10 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

2Treatment groups
Experimental Treatment
Group I: Control-IQ 2.0 Standard TargetExperimental Treatment1 Intervention
Participants will use t:slim X2 pump with Control-IQ technology 2.0 at a standard target for two weeks.
Group II: Control-IQ 2.0 Alternate TargetExperimental Treatment1 Intervention
Participants will use t:slim X2 pump with Control-IQ technology 2.0 at an alternate target for two weeks.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
t:slim X2 insulin pump with Control-IQ technology 2.0
2023
N/A
~80

Find a Location

Who is running the clinical trial?

Tandem Diabetes Care, Inc.Lead Sponsor
37 Previous Clinical Trials
5,615 Total Patients Enrolled
Jordan Pinsker, MDStudy DirectorTandem Diabetes Care, Inc.
10 Previous Clinical Trials
3,816 Total Patients Enrolled

Media Library

t:slim X2 insulin pump with Control-IQ technology 2.0 (Device) Clinical Trial Eligibility Overview. Trial Name: NCT05683392 — N/A
Type 1 Diabetes Research Study Groups: Control-IQ 2.0 Alternate Target, Control-IQ 2.0 Standard Target
Type 1 Diabetes Clinical Trial 2023: t:slim X2 insulin pump with Control-IQ technology 2.0 Highlights & Side Effects. Trial Name: NCT05683392 — N/A
t:slim X2 insulin pump with Control-IQ technology 2.0 (Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05683392 — N/A
Type 1 Diabetes Patient Testimony for trial: Trial Name: NCT05683392 — N/A

Frequently Asked Questions

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

Does this research endeavor enlist those over the age of 45?

"This research effort is seeking individuals aged 2 to 80 who meet the trial's eligibility criteria. Notably, there are 218 experiments open for minors and 902 trials available for elderly patients."

Answered by AI

Are there any opportunities for patient enrollment in this trial?

"A review of clinicaltrials.gov reveals that this particular medical study is not presently recruiting patients. It was first launched on January 30th 2023 and last revised on the 5th of January, 2023. Nonetheless, 1229 other trials are in search for participants as we speak."

Answered by AI

What is the end goal of this experiment?

"Tandem Diabetes Care, Inc., the trial sponsor for this study, has set as its main objective to measure Number of diabetic ketoacidosis (DKA) events over a 6 week period. Additionally, they plan on assessing secondary outcomes such as CGM percent time <54 mg/dL during each study period; CGM percent time <70 mg/dL during each study period.; and lastly, quantifying CGM percent time 70-180 mg/dL throughout the course of their research."

Answered by AI

Is this research open to new volunteers?

"This clinical trial is seeking 72 individuals with type 1 diabetes between the ages of 2 and 80. The potential participants must possess an HbA1c level lower than 10.5%, weigh at least 20 lbs, take a minimum of two units/day insulin, and have utilized Dexcom CGM for 11 or more days in the 14 prior to screening. Furthermore, those under 18 need to be accompanied by a parent or legal guardian knowledgeable about emergency hypoglycemia procedures during meals challenges as well as willing to use the Dexcom Follow app; adults over 18 require access to a local contact who meets similar qualifications. Lastly, all enrol"

Answered by AI

Who else is applying?

What state do they live in?
New Hampshire
What site did they apply to?
Joslin Diabetes Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0

Why did patients apply to this trial?

I currently use the tandem pump with control IQ but hope with future research the targets will change and technology will advance for tighter glycemic control.
PatientReceived 1 prior treatment
~33 spots leftby Apr 2025