Extended Insulin Bolus for Type 1 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial examines whether an extended insulin bolus can better manage blood sugar levels in people with type 1 diabetes when consuming meals high in fat and protein. Participants will test both a standard and an extended insulin dose to determine which is more effective. Individuals who have had type 1 diabetes for at least a year, use a specific insulin pump system, and are willing to follow meal recommendations may be suitable candidates. As a Phase 4 trial, this research aims to understand how the already FDA-approved treatment benefits a broader range of patients.
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 start any new non-insulin glucose-lowering medications during the trial.
What is the safety track record for these treatments?
Research has shown that both extended and standard insulin doses are generally safe for people with Type 1 diabetes. One study on a type of insulin similar to the one used in these trials found it safe when used alone or with other diabetes medications, suggesting that extended insulin doses should also be well-tolerated.
Standard insulin doses have been widely used and are known to help control blood sugar levels. Studies have demonstrated they can safely manage glucose levels and reduce complications in people with diabetes.
Since this trial is in an advanced phase, extensive research has already confirmed the safety of both types of insulin doses. Participants can feel reassured that these treatments have passed earlier safety checks.12345Why are researchers enthusiastic about this study treatment?
Researchers are excited about the extended insulin bolus for Type 1 Diabetes because it offers a new way to manage blood sugar levels, especially after meals high in fat and protein. Unlike the standard insulin bolus, which is typically given in one go, the extended bolus is delivered gradually over time. This method aims to better mimic the body's natural insulin release, potentially leading to more stable blood sugar levels and reducing spikes that can occur with traditional dosing. This approach could offer a significant improvement in daily glucose management for people with Type 1 Diabetes.
What evidence suggests that this trial's treatments could be effective for Type 1 Diabetes?
Research has shown that an extended insulin bolus can help control blood sugar after meals high in fat and protein. One study demonstrated that this method helped people with type 1 diabetes avoid prolonged high blood sugar levels. Participants in the trial will receive either an extended insulin bolus or a standard insulin bolus. The extended bolus allows insulin to work over a longer period, helping to prevent both high blood sugar and sudden drops. While the standard insulin bolus effectively lowers blood sugar after meals, the extended bolus might offer better control in certain situations. Both methods are safe and have proven effective in managing blood sugar levels.45678
Who Is on the Research Team?
Laya Ekhlaspour, MD
Principal Investigator
University of California, San Francisco
Are You a Good Fit for This Trial?
This trial is for teens (13-18) with Type 1 Diabetes who use a smartphone and the Control IQ closed-loop system. They must have an A1C over 6%, not be on new diabetes meds other than insulin, and agree to follow meal/study guidelines. It's not for those with severe diabetes complications, untreated thyroid issues, or certain chronic conditions.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive standard and extended insulin bolus for high-fat high-protein meals over two days
Follow-up
Participants are monitored for glucose control effectiveness and safety post-treatment
What Are the Treatments Tested in This Trial?
Interventions
- Extended bolus of insulin
- Standard bolus of insulin
Extended bolus of insulin is already approved in European Union, United States, Canada for the following indications:
- diabetes mellitus in adults, adolescents and children aged 2 years and above
- type 1 diabetes
- type 2 diabetes
- type 1 diabetes
- type 2 diabetes
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, San Francisco
Lead Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator