Insulin Bolus Required for High Fat Foods in Type 1 Diabetes

Type 1 Diabetes Clinical Trial

Official title:

Evaluation of Insulin Bolus for High Fat Meals

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02248454
• Other study ID #: High fat bolus
• Status: Completed
• Phase: N/A
• First received: September 22, 2014
• Last updated: April 25, 2017
• Start date: September 2014
• Est. completion date: April 2015

Study information

• Verified date: April 2017
• Source: Joslin Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Drug:
• Lispro
Increasing insulin doses

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Joslin Diabetes Center	Boston Children’s Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictors of fat "sensitivity"	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.	0-360 minutes