Hybrid Closed Loop Therapy for Type 1 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to evaluate the effectiveness of different hybrid closed loop (HCL) insulin pump systems for people with type 1 diabetes (T1D) from underserved communities. These systems automatically adjust insulin delivery and may improve blood sugar management. Participants will either use one of three HCL systems or continue with regular insulin injections to compare effectiveness and user experience. The trial seeks adults with T1D who have had the condition for at least a year, use multiple daily insulin injections, and have an A1c level over 7.5% (a measure of average blood sugar levels). As an unphased trial, it offers participants the chance to contribute to significant research that could enhance diabetes management for underserved communities.
Do I need to stop my current medications to join the trial?
You may need to stop certain medications to join the trial. If you are currently using SGLT-2 inhibitors, sulfonylureas, or hydroxyurea, you cannot participate. If you are on GLP-1RA, pramlintide, or metformin, you must be on a stable dose for 3 months before joining.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that the Tandem Control IQ hybrid closed loop (HCL) system is generally safe for people with type 1 diabetes. Studies have found that it lowers A1c levels, which measure blood sugar control, without increasing the risk of low blood sugar. The system is approved for children as young as six, indicating it is well-tolerated across different ages.
The Insulet OP 5 HCL system is also considered safe, with FDA approval for children as young as two. However, it should not be used with certain medications like hydroxyurea. Some users have experienced high blood sugar levels shortly after starting the device, but these cases appear to be rare.
The BetaBionics iLet HCL system is approved for those aged six and older. Safety information suggests it helps people with type 1 diabetes manage their condition effectively. Reports of high A1c levels have occurred in users with complex medical conditions, but these are specific cases.
Overall, these systems are FDA-approved, meaning they have passed safety checks for managing type 1 diabetes. It's important to consider personal health needs and consult healthcare providers when choosing a treatment.12345Why are researchers excited about this trial?
Researchers are excited about the Hybrid Closed Loop (HCL) systems being tested for type 1 diabetes because these devices offer a more automated approach to insulin delivery than traditional methods like multiple daily injections or standard pumps. The Tandem Control IQ HCL system, Insulet OP 5 HCL system, and BetaBionics iLet HCL system each integrate continuous glucose monitoring with insulin pumping, providing real-time adjustments to insulin delivery without constant manual input. This could mean fewer blood sugar highs and lows and a more stable daily experience for users. These systems aim to simplify diabetes management, making it easier for people to maintain optimal blood glucose levels with less effort and stress.
What evidence suggests that this trial's treatments could be effective for type 1 diabetes?
This trial will compare different hybrid closed-loop (HCL) systems for managing type 1 diabetes. Participants may be randomized to use the Tandem Control IQ system, which has proven to improve blood sugar control and enhance users' quality of life, maintaining blood sugar within a healthy range about 75% of the time. Another group will use the Insulet OP 5 system, which significantly lowers HbA1c levels and improves blood sugar management compared to traditional methods. The BetaBionics iLet system, newly approved by the FDA, is also being tested and has shown effective improvement in blood sugar control. These systems automate insulin delivery, simplifying life for people with diabetes.678910
Who Is on the Research Team?
Howard Wolpert, MD
Principal Investigator
Boston Medical Center
Are You a Good Fit for This Trial?
This trial is for adults with Type 1 Diabetes, particularly from underserved communities who may have higher A1c levels and more complications. It's designed to be inclusive, even if participants have significantly elevated A1c values.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are randomized to one of three FDA-approved HCL systems or continuous glucose monitoring and multiple daily injection therapy
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Device specific training
- Study clinician/educator visit
Find a Clinic Near You
Who Is Running the Clinical Trial?
Boston Medical Center
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator