Insulin Bolus Required for High Fat Foods in Type 1 Diabetes
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02248454|
Recruitment Status : Completed
First Posted : September 25, 2014
Last Update Posted : April 26, 2017
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).
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Drug: Lispro||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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Insulin Bolus for High Fat Meals|
|Study Start Date :||September 2014|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
Experimental: Insulin bolus dose/type
Lispro insulin, dose calculated by modeling analysis
Increasing insulin doses
Other Name: Humalog
- Predictors of fat "sensitivity" [ 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02248454
|Principal Investigator:||Howard Wolpert, MD||Joslin Diabetes Center|