30 Participants Needed

Extended Insulin Bolus for Type 1 Diabetes

RW
LE
Overseen ByLaya Ekhlaspour, MD
Age: < 65
Sex: Any
Trial Phase: Phase 4
Sponsor: University of California, San Francisco
Must be taking: Insulin
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

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.12345

Why 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?

LE

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

I have been diagnosed with type 1 diabetes for over a year.
You are currently using the Control IQ closed-loop system.
Willing to abide by meal recommendations and study procedures
See 8 more

Exclusion Criteria

Pregnancy or lactation
Current illness that would interfere with participation in the study
I am currently receiving cancer treatment or taking steroids.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive standard and extended insulin bolus for high-fat high-protein meals over two days

2 days
2 visits (in-person)

Follow-up

Participants are monitored for glucose control effectiveness and safety post-treatment

5 hours post-bolus

What Are the Treatments Tested in This Trial?

Interventions

  • Extended bolus of insulin
  • Standard bolus of insulin
Trial Overview The study tests if extending the time insulin is delivered after eating high-fat/protein meals can better control blood sugar in Type 1 Diabetics using a closed-loop system. Participants will try both standard and extended boluses of insulin to see which manages glucose levels more effectively.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Group I: High Fat High Protein (HFHP) Meal- standard then extended insulin bolus armExperimental Treatment1 Intervention
Group II: High Fat High Protein (HFHP) Meal- extended then standard insulin bolus armExperimental Treatment1 Intervention

Extended bolus of insulin is already approved in European Union, United States, Canada for the following indications:

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Approved in European Union as insulin for:
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Approved in United States as insulin for:
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Approved in Canada as insulin for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of California, San Francisco

Lead Sponsor

Trials
2,636
Recruited
19,080,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials
2,513
Recruited
4,366,000+

Published Research Related to This Trial

In a study of 565 women treated with onabotulinumtoxinA for overactive bladder, there was no significant difference in urinary retention requiring clean intermittent catheterization between diabetic patients (5.8%) and non-diabetic patients (9%).
However, diabetic patients had a higher rate of urinary tract infections (UTIs) post-procedure (38.1% vs. 27.6%), and the presence of diabetes-related complications was linked to an increased risk of UTIs.
The Correlation of Diabetes Mellitus and Urinary Retention From Intravesical OnabotulinumtoxinA Injection for Overactive Bladder.Takashima, Y., Handler, S., Laus, K., et al.[2023]
In a pooled analysis of two Phase III studies involving 374 participants, treatment with 50 U of abobotulinumtoxinA (aboBoNT-A) solution resulted in 88% of subjects experiencing none-or-mild glabellar lines one month after treatment, with effects lasting up to 6 months.
The treatment was well tolerated, with mostly mild or moderate nonserious adverse events, and showed high subject satisfaction regarding both appearance and psychological well-being compared to placebo.
Liquid AbobotulinumtoxinA: Pooled Data From Two Double-Blind, Randomized, Placebo-Controlled Phase III Studies of Glabellar Line Treatment.Hilton, S., Kestemont, P., Sattler, G., et al.[2022]
Botulinum toxin type A (BoNTA) is recommended for managing refractory idiopathic Overactive Bladder, with guidelines emphasizing the importance of treating urinary tract infections before injection and ensuring patients can self-catheterize.
The injection procedure should be performed under local anesthesia in a controlled setting, with specific techniques to minimize risks, such as avoiding overfilling the bladder and monitoring patients post-injection for effective outcomes.
[Guidelines for practical usage of botulinum toxin type A (BoNTA) for refractory idiopathic overactive bladder management].Hermieu, JF., Ballanger, P., Amarenco, G., et al.[2017]

Citations

Insulin Therapy in Adults with Type 1 Diabetes MellitusHere, we review insulin management options and strategies in nonpregnant adult patients with type 1 diabetes mellitus (T1DM).
Extended Insulin Bolus for Type 1 DiabetesThis 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.
Optimal model-based insulin bolus advisor for subjects ...This paper presents an optimal model-based bolus advisor aimed at improving insulin therapy for individuals with type 1 diabetes who actively utilize ...
Efficacy and safety of once‐weekly basal insulin therapy in ...This meta-analysis is the first to evaluate the efficacy and safety of once-weekly basal insulins in the treatment of adults with type 1 ...
Navigating Insulin Options for Diabetes ManagementCompared to a separate basal/bolus regimen, mixed insulin has been shown to have similar outcomes in glycemic control and hypoglycemia rates (31 ...
Safety and Effectiveness of Bolus Insulin Aspart in People ...This sub-analysis evaluated clinical safety and effectiveness of bolus insulin aspart (±OGLDs) as the only insulin therapy. Data were analyzed ...
Boluses in Insulin Therapy: A Commentary - PMCFour missed meal boluses per week can result in a 1% increase in HbA1c. One possible way to reduce missed boluses can be so-called reminder functions in medical ...
Practical Aspects and Exercise Safety Benefits of Automated ...Automated insulin delivery (AID) technology has been shown to modestly improve glycemic time in range (TIR) in adults with type 1 diabetes.
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