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Device
Control-IQ 2.0 Standard 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
No Placebo-Only Group
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 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Number of diabetic ketoacidosis (DKA) events
Number of other serious device-related adverse events
Number of severe hypoglycemic events
+1 moreSecondary study objectives
All device-related adverse events
CGM metrics for time in range by time of day
Coefficient of variation
+10 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
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
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Who is running the clinical trial?
Tandem Diabetes Care, Inc.Lead Sponsor
39 Previous Clinical Trials
5,601 Total Patients Enrolled
Jordan Pinsker, MDStudy DirectorTandem Diabetes Care, Inc.
11 Previous Clinical Trials
3,845 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a serious kidney problem or need to undergo hemodialysis.You have experienced severe low blood sugar more than once in the past 6 months and needed help to treat it.You have a condition that makes you bleed more easily, like hemophilia or another bleeding disorder.You are willing and able to eat specific meals as part of the study.You have had problems with your adrenal glands in the past.You have had more than one episode of a serious condition called diabetic ketoacidosis (DKA) in the past 6 months.You have a history of gastroparesis, a condition that affects how your stomach empties.You are taking any medicine to lower your blood sugar, except for metformin. Examples of these medicines include GLP-1 agonists, Symlin, DPP-4 inhibitors, SGLT-2 inhibitors, and sulfonylureas.You have had an allergic reaction to Humalog or Novolog in the past.
Research Study Groups:
This trial has the following groups:- Group 1: Control-IQ 2.0 Standard Target
- Group 2: Control-IQ 2.0 Alternate Target
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Type 1 Diabetes Patient Testimony for trial: Trial Name: NCT05683392 — N/A
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