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

Trial Summary

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 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.12345

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.16789

How is the extended insulin bolus treatment different from other insulin therapies for Type 1 Diabetes?

The extended insulin bolus treatment is unique because it delivers insulin over a longer period compared to the standard bolus, which may help in better managing blood sugar levels during meals that are high in fat or protein, as these can cause delayed blood sugar spikes.1011121314

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.

Research Team

LE

Laya Ekhlaspour, MD

Principal Investigator

University of California, San Francisco

Eligibility Criteria

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

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

Treatment Details

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.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: High Fat High Protein (HFHP) Meal- standard then extended insulin bolus armExperimental Treatment1 Intervention
Subjects will receive standard meal bolus for breakfast on the first day and extended meal bolus on the second day.
Group II: High Fat High Protein (HFHP) Meal- extended then standard insulin bolus armExperimental Treatment1 Intervention
Subjects will receive extended meal bolus for breakfast on the first day and standard meal bolus on the second day of the study.

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

🇪🇺
Approved in European Union as insulin for:
  • diabetes mellitus in adults, adolescents and children aged 2 years and above
🇺🇸
Approved in United States as insulin for:
  • type 1 diabetes
  • type 2 diabetes
🇨🇦
Approved in Canada as insulin for:
  • type 1 diabetes
  • type 2 diabetes

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+

Findings from Research

In a study involving 232 type 1 diabetic patients over 26 weeks, switching to insulin detemir from NPH insulin or glargine did not change HbA1c levels but significantly reduced fasting blood glucose variability and the risk of nighttime hypoglycemic episodes.
Insulin detemir improved patients' quality of life with only a slight increase in daily insulin doses and no associated weight gain, highlighting its safety and efficacy as a basal insulin option.
[Insulin detemir in the predictive study: results in patients with type 1 diabetes in the Belgian cohort].Philips, JC., Scheen, AJ.[2022]
In a study involving 100 young patients with type 1 diabetes, switching to insulin glargine (Lantus) and insulin glulisine (Apidra) significantly reduced average HbA1c levels from 8.3% to 7.7% over 24 months, indicating improved blood sugar control.
The therapy was found to be safe, with no recorded cases of severe or nocturnal hypoglycemia, and it did not lead to the progression of microvascular complications, enhancing the overall quality of life for the patients.
[Use of human insulin analogues in young patients with type 1 diabetes mellitus: Results of the RESULT observational program on the use of insulin glargine (Lantus) in combination with insulin glulisine (Apidra) as a basal-bolus regimen].Efremova, NV., Bolotskaya, LL., Atarshchikov, DS., et al.[2019]
In a study involving 112 children and adolescents with type 1 diabetes, the combination of ultrashort acting insulin aspart with detemir or glargine showed a significant decrease in HbA1c levels, indicating improved blood sugar control over 12 and 24 weeks.
The use of detemir and glargine significantly reduced the risk of hypoglycemia compared to traditional NPH-insulin, while maintaining a stable body mass index in the detemir group, suggesting a safer and more effective treatment option.
[Basal insulin analogue versus traditional NPH insulin in basal bolus therapy of children and adolescents with type 1 diabetes].Prikhodina, OA., Surikova, SV., Girsh, YV.[2020]

References

[Insulin detemir in the predictive study: results in patients with type 1 diabetes in the Belgian cohort]. [2022]
2.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Use of human insulin analogues in young patients with type 1 diabetes mellitus: Results of the RESULT observational program on the use of insulin glargine (Lantus) in combination with insulin glulisine (Apidra) as a basal-bolus regimen]. [2019]
3.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Basal insulin analogue versus traditional NPH insulin in basal bolus therapy of children and adolescents with type 1 diabetes]. [2020]
Real world outcomes of adding rapid-acting insulin versus switching to analog premix insulin among US patients with type 2 diabetes treated with insulin glargine. [2021]
The past, present, and future of basal insulins. [2022]
Update on insulin analogues. [2019]
Differences in bioactivity between human insulin and insulin analogues approved for therapeutic use- compilation of reports from the past 20 years. [2021]
Comparison of one-year costs of type 2 diabetes treatment with insulin glargine or insulin detemir in a basal supported oral therapy (BOT) in Germany. [2019]
Efficacy and Safety of Biosimilar SAR342434 Insulin Lispro in Adults with Type 1 Diabetes Also Using Insulin Glargine-SORELLA 1 Study. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
The Correlation of Diabetes Mellitus and Urinary Retention From Intravesical OnabotulinumtoxinA Injection for Overactive Bladder. [2023]
11.United Statespubmed.ncbi.nlm.nih.gov
Liquid AbobotulinumtoxinA: Pooled Data From Two Double-Blind, Randomized, Placebo-Controlled Phase III Studies of Glabellar Line Treatment. [2022]
[Guidelines for practical usage of botulinum toxin type A (BoNTA) for refractory idiopathic overactive bladder management]. [2017]
Guidelines for practical usage of botulinum toxin type A (BoNTA) for refractory idiopathic overactive bladder management: Translation of French recommendations. [2014]
14.United Statespubmed.ncbi.nlm.nih.gov
Efficacy and safety of onabotulinumtoxinA therapy are sustained over 4 years of treatment in patients with neurogenic detrusor overactivity: Final results of a long-term extension study. [2022]
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