Your session is about to expire
← Back to Search
Insulin Pump
Control-IQ Technology for Type 2 Diabetes (2IQP Trial)
N/A
Recruiting
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
Progestogen-only hormonal contraception associated with inhibition of ovulation (oral, injectable, implantable)
Combined estrogen and progestogen containing hormonal contraception associated with inhibition of ovulation (oral, intravaginal, transdermal)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 13 weeks
Awards & highlights
2IQP Trial Summary
This trial looks at using new technology to help adults with type 2 diabetes manage their blood sugar levels.
Who is the study for?
Adults over 18 with type 2 diabetes in the U.S. or Canada, using basal-bolus insulin therapy for at least 3 months without recent changes. Participants must not start new glucose-lowering meds during the trial, change doses of current meds unless necessary, use concentrated or inhaled insulin, and must be able to complete study visits and tasks.Check my eligibility
What is being tested?
The trial is testing Control-IQ technology which includes a t:slim X2 insulin pump paired with Dexcom G6 CGM against standard therapy plus CGM alone. The goal is to see if this tech can better manage blood sugar levels in adults with type 2 diabetes on insulin therapy.See study design
What are the potential side effects?
Potential side effects may include skin irritation from device adhesives, hypoglycemia (low blood sugar), hyperglycemia (high blood sugar) due to incorrect insulin dosing by the devices, and possible allergic reactions to materials used in the pumps or sensors.
2IQP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am using birth control that contains progestogen only.
Select...
I am using a birth control method that contains both estrogen and progestogen.
Select...
My fallopian tubes are surgically blocked.
Select...
I am 18 years old or older.
Select...
I agree not to start any new diabetes medications during the trial.
Select...
I agree not to use concentrated or inhaled insulin while in the study.
2IQP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 13 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
HbA1c
Secondary outcome measures
CGM-measured hypoglycemia events
Coefficient of variation
Mean glucose
+6 moreOther outcome measures
Area over the curve (70 mg/dL)
Area under the curve (180 mg/dL)
Basal insulin
+38 moreSide effects data
From 2016 Phase 4 trial • 85 Patients • NCT0197024121%
Hypoglycemia
100%
80%
60%
40%
20%
0%
Study treatment Arm
NPH With Corticosteroid
Control
2IQP Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Intervention groupExperimental Treatment1 Intervention
Participants who skip or successfully complete the run-in will be randomly assigned 2:1 to the Intervention group using t:slim X2 insulin pump with Control-IQ technology 1.5 and Dexcom G6 CGM for 13 weeks.
Group II: Control groupActive Control1 Intervention
Continuation of pre-study basal-bolus insulin delivery method, plus use of study CGM (Dexcom G6).
Find a Location
Who is running the clinical trial?
Tandem Diabetes Care, Inc.Lead Sponsor
37 Previous Clinical Trials
5,380 Total Patients Enrolled
Jaeb Center for Health ResearchOTHER
153 Previous Clinical Trials
34,611 Total Patients Enrolled
Yogish Kudva, MBBSStudy ChairMayo Clinic
1 Previous Clinical Trials
14 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am not using and do not plan to use steroid pills or injections during the trial.I am currently taking sulfonylurea or meglitinide medications.I am willing to follow the study's diet and exercise plan and have someone to help me if my blood sugar gets too low.I understand the details of the clinical trial and can make informed decisions.I am using birth control that contains progestogen only.I don't have any health or mental conditions that would make it unsafe for me to join the study.You have a condition that may make it difficult to measure your HbA1c levels accurately.I've been on a stable insulin treatment with daily rapid-acting insulin for over 3 months.My diabetes or weight-loss medication dose has been stable for 3 months, and I'm willing to keep it unchanged unless for safety.I have been diagnosed with type 2 diabetes for at least 6 months.I am using a birth control method that contains both estrogen and progestogen.I am currently taking hydroxyurea.My fallopian tubes are surgically blocked.You are currently using a hybrid closed-loop system.I am 18 years old or older.This criterion is not applicable on its own.I am willing to use approved insulin with the study pump if needed.You must use condoms or other contraceptive methods that create a barrier and include sperm-killing substances.I agree not to start any new diabetes medications during the trial.You have an allergy to tape or a skin condition that would prevent you from using the study pump or CGM.I agree not to use concentrated or inhaled insulin while in the study.I can use the study devices safely and follow the study plan.
Research Study Groups:
This trial has the following groups:- Group 1: Intervention group
- Group 2: Control group
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.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many health care centers are currently conducting this research experiment?
"Seven clinical trial sites are currently enrolling participants, including Boston Medical Center Corporation in Boston, Icahn School of Medicine at Mt. Sinai in New york and SUNY Upstate Medical University in Syracuse. Additional recruitment locations have also been established around the country."
Answered by AI
Are recruitment opportunities available for this experiment?
"That is correct. According to the information on clinicaltrials.gov, this medical study opened for recruitment on June 1st 2023 and was recently updated on June 2nd 2023; 300 patients are needed from 7 different sites in total."
Answered by AI
How many participants are trialing the therapy?
"To complete the clinical trial, approximately three-hundred suitable patients are needed. There are multiple locations that potential participants can choose from such as Boston Medical Center Corporation in Massachusetts and Mt. Sinai's Icahn School of Medicine in New york City."
Answered by AI
Who else is applying?
What site did they apply to?
Mayo Clinic
Hoag Memorial Hospital Presbyterian
University of Pennsylvania
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
Why did patients apply to this trial?
My glucose numbers have been way out of control and I need to get them under better control.
PatientReceived 1 prior treatment
How responsive is this trial?
Most responsive sites:
- Hoag Memorial Hospital Presbyterian: < 48 hours
Average response time
- < 2 Days
Typically responds via
Phone Call
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger