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Insulin Bolus Required for High Fat Foods in Type 1 Diabetes

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ClinicalTrials.gov Identifier: NCT02248454
Recruitment Status : Completed
First Posted : September 25, 2014
Last Update Posted : April 26, 2017
Sponsor:
Collaborator:
Boston Children’s Hospital
Information provided by (Responsible Party):
Joslin Diabetes Center

Study Description
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Brief Summary:

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

Detailed Description:

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
Experimental: Insulin bolus dose/type
Lispro insulin, dose calculated by modeling analysis
 Drug: Lispro
Increasing insulin doses
Other Name: Humalog


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients (aged 18-75 years) with type 1 diabetes > 3 years, on insulin pump therapy.

Exclusion Criteria:

  • History or symptoms suggestive of gastroparesis or gastric dysmotility; History of celiac disease, pancreatic exocrine dysfunction or other conditions that cause malabsorption or maldigestion; Eating disorder; Diet allergies; Special diet restrictions, such as vegan; Medications know to affect insulin sensitivity (such as glucocorticoids) or affect gastrointestinal motility (such as reglan); High-titre insulin autoantibodies with delayed insulin kinetics; Women who are breast feeding, pregnant, or wanting to become pregnant.
Contacts and Locations
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Information from the National Library of Medicine

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


Sponsors and Collaborators
Joslin Diabetes Center
Boston Children’s Hospital
Investigators
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Principal Investigator: Howard Wolpert, MD Joslin Diabetes Center
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Joslin Diabetes Center
ClinicalTrials.gov Identifier: NCT02248454     History of Changes
Other Study ID Numbers: High fat bolus
First Posted: September 25, 2014    Key Record Dates
Last Update Posted: April 26, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
 Immune System Diseases
Insulin
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs