Closed-loop Insulin Delivery for Type 1 Diabetes during Pregnancy
(CIRCUIT Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial focuses on improving insulin delivery for pregnant women with type 1 diabetes using a new insulin pump system. Researchers are testing whether the Tandem t:slim X2 insulin pump with Control IQ technology, combined with a continuous glucose monitor (CGM), outperforms standard insulin delivery methods. The goal is to determine if this new system can maintain better blood sugar control during pregnancy. Women who have managed type 1 diabetes for at least a year, are less than 14 weeks pregnant with one baby, and are already on intensive insulin therapy might be suitable candidates for this trial. As an unphased trial, this study offers a unique opportunity to explore innovative technology that could enhance diabetes management during pregnancy.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot be on drugs that interfere with glucose metabolism, like high-dose corticosteroids. It's best to discuss your specific medications with the trial team.
What prior data suggests that the Tandem t:slim X2 insulin pump with Control IQ technology is safe for pregnant women with type 1 diabetes?
Research has shown that the Tandem t:slim X2 insulin pump with Control IQ technology is safe for pregnant women with type 1 diabetes. Studies found that pregnant women used this pump without major safety issues. However, its effectiveness in controlling blood sugar levels varied among individuals. Overall, the pump was well-tolerated, with most users experiencing no significant problems. For those considering joining a trial with this pump, existing research suggests it has a strong safety record.12345
Why are researchers excited about this trial?
Researchers are excited about the Tandem t:slim X2 insulin pump with Control IQ technology because it offers a sophisticated closed-loop system for managing Type 1 Diabetes during pregnancy. Unlike traditional methods, which often involve multiple daily injections or standard insulin pumps, this system automatically adjusts insulin delivery based on continuous glucose monitoring (CGM) data from the Dexcom G6. This technology aims to improve glucose control by predicting and preventing both high and low blood sugar levels, potentially leading to better health outcomes for both the mother and baby.
What evidence suggests that the Tandem t:slim X2 insulin pump with Control IQ technology is effective for type 1 diabetes during pregnancy?
Research has shown that the Tandem t:slim X2 insulin pump with Control IQ technology, which participants in this trial may receive, has been safely used during pregnancy for people with type 1 diabetes. However, its effectiveness in achieving recommended blood sugar levels can vary. In a large study with a similar system called CamAPS® FX, participants spent 10% more time with their blood sugar in the target range compared to those using standard insulin therapy. This finding suggests it might better manage blood sugar levels. Overall, while the technology appears promising, individual results may vary.13467
Who Is on the Research Team?
Denice Feig, MD
Principal Investigator
MOUNT SINAI HOSPITAL
Lois Donovan, MD
Principal Investigator
University of Calgary
Are You a Good Fit for This Trial?
This trial is for pregnant women aged 18-45 with type 1 diabetes, who are less than 14 weeks into their pregnancy and have been managing their condition with intensive insulin therapy. Participants should have an A1c level between 6.5% and <10%, be able to use email, and consent to using the study devices throughout the trial. Women with severe diabetes complications or on treatments affecting glucose metabolism cannot join.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either the Tandem t:slim X2 insulin pump with Control IQ technology or standard insulin delivery (MDI or pump) with CGM
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Tandem t:slim X2 insulin pump with Control IQ technology
Trial Overview
The CIRCUIT trial is testing the effectiveness of a Tandem t:slim X2 insulin pump equipped with Control IQ technology in managing blood sugar levels during pregnancy compared to standard insulin delivery plus continuous glucose monitoring (CGM) in women with type 1 diabetes.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
Participants randomized to the intervention group will be fitted with the Tandem t:slim X2 insulin pump with Control IQ technology and Dexcom G6 Continuous Glucose Monitor.
Participants randomized to the control group will be fitted with the Dexcom G6 Continuous Glucose Monitor. They will continue to use standard insulin delivery (MDI or pump) and CGM.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Calgary
Lead Sponsor
Citations
Tandem T:Slim X2 Insulin Pump Use in Clinical Practice ...
Tandem t:slim X2 insulin pumps were safely used during pregnancy in eight individuals with T1D, with variable success in achieving recommended glycemic targets.
Tandem T:Slim X2 Insulin Pump Use in Clinical Practice ...
Conclusions: Tandem t:slim X2 insulin pumps were safely used during pregnancy in eight individuals with T1D, with variable success in achieving ...
Use of advanced technology for the treatment of type 1 ...
A large randomized controlled trial (RCT) with the CamAPS® FX showed a 10 % increase in time in range compared to standard insulin therapy in ...
4.
ajmc.com
ajmc.com/view/t-slim-x2-insulin-pump-use-safe-in-pregnant-individuals-with-t1d-but-efficacy-variesT:Slim X2 Insulin Pump Use Safe in Pregnant Individuals ...
Tandem t:slim X2 insulin pumps were safely used during pregnancy in individuals with type 1 diabetes (T1D) but had variable success in achieving glycemic ...
NCT04902378 | Closed-loop Insulin Delivery In Type 1 ...
This trial will assess the efficacy of the Tandem t:slim X2 insulin pump with Control IQ technology compared with standard insulin delivery plus CGM in pregnant ...
6.
diabetes.org
diabetes.org/newsroom/press-releases/smart-insulin-tech-helps-pregnant-women-type-1-diabetes-maintain-targetSmart Insulin Tech Helps Pregnant Women with Type 1 ...
A new study shows pregnant women with type 1 diabetes stayed in the target blood glucose (blood sugar) range for pregnancy more often with an automated insulin ...
7.
tandemdiabetes.com
tandemdiabetes.com/providers/clinical-evidence/2020-jun-control-iq-glycemic-outcomesControl-IQ Technology Real World Glycemic Outcomes
Check out our study to determine real-world glycemic outcomes for users of the t:slim X2 insulin pump with Control-IQ technology.
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