Lispro
DrugIncreasing insulin doses
Other names: Humalog
NCT Number: NCT02248454
The purpose of this study is to evaluate an insulin bolus for use to cover higher fat meals.
Subjects will have several admissions during which the investigators will apply an iterative dose escalation protocol to derive an optimized insulin bolus dose (carbohydrate-to-insulin ratio for fat to minimize postprandial hyperglycemia following higher fat meals. The investigators hypothesize that the incremental insulin dose required to cover dietary fat in patients with type 1 diabetes will be related to total daily insulin dose (U/kg).
Looking for future studies?
Notify Me18 year–75 year
All sexes
Interventional
Not applicable
Subjects for this study will be adults with type 1 diabetes who use an insulin pump for diabetes self-management.
Subjects will be admitted to the clinical research center in the morning in the fasting state. Subjects will have several admissions. During the initial two admissions, subjects will receive either pizza-low fat or pizza-high fat, covered with insulin doses calculated from their usual insulin-to-carbohydrate ratio. Study subjects in whom the bolus did not provide adequate insulin coverage for pizza-high fat will then undergo an additional 1-5 admissions during which they will receive the pizza-high fat meal with progressively increasing insulin doses until ≥ 90% of all postprandial glucose values are within the target range 80-180 mg/dL.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Increasing insulin doses
Other names: Humalog
Time frame: 0-360 minutes
To test the hypothesis that incremental dose increase required to cover dietary fat in patients with type 1 diabetes will be related to total daily insulin dose (TDD; U/kg) we will perform regression analysis with TDD as independent variable and the increase in insulin requirements (calculated as percent change for high fat vs low fat meal) as the dependent variable.
Joslin Diabetes Center
Other
Evaluation of Insulin Bolus for High Fat Meals
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05488119
Autoimmune Diseases, Diabetes Mellitus
Stanford, California, United States
View Trial DetailsNCT07696780
Autoimmune Diseases, Diabetes Mellitus
Bern, Canton of Bern, Switzerland
View Trial DetailsNCT05610111
Autoimmune Diseases, Diabetes Mellitus
Charlottesville, Virginia, United States
View Trial DetailsNCT06308549
Autoimmune Diseases, Diabetes Distress
Bad Mergentheim, Baden-Wurttemberg, Germany
View Trial Details