Extended Insulin Bolus for Type 1 Diabetes
What You Need to Know Before You Apply
What is the purpose of this trial?
This study aims to evaluate whether the use of an extended bolus will improve glucose control with high-fat high protein meals using a closed-loop system. The new knowledge gained from this study may provide a method to allow for the proper administration of insulin over an extended period to mitigate the risk of prolonged hyperglycemia or early hypoglycemia.
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.
Is extended insulin bolus safe for humans?
Insulin detemir (Levemir) has been shown to reduce the risk of low blood sugar episodes, especially at night, without causing weight gain, which suggests it is generally safe for humans. Additionally, biosimilar insulin lispro has demonstrated similar safety to its original version in adults with type 1 diabetes.12345
How is the extended insulin bolus treatment different from other insulin therapies for Type 1 Diabetes?
What data supports the effectiveness of the drug Extended Insulin Bolus for Type 1 Diabetes?
Research shows that insulin detemir (Levemir) and insulin glargine (Lantus), which are part of the insulin therapy, can improve blood sugar control and reduce the risk of low blood sugar episodes in people with type 1 diabetes. These insulins help maintain stable blood sugar levels, especially overnight, and improve quality of life without causing weight gain.311121314
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