Insulin Bolus Required for High Fat Foods in Type 1 Diabetes

NCT02248454 | Completed

• 1 other identifier: High fat bolus
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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).

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Insulin bolus dose/type

EXPERIMENTAL

Lispro insulin, dose calculated by modeling analysis

Drug: Lispro

Interventions

Lispro DRUG

Increasing insulin doses

Also known as: Humalog

Insulin bolus dose/type

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Joslin Diabetes Center: lead
• Boston Children's Hospital: collaborator

Related Publications (1)

• Bell KJ, Toschi E, Steil GM, Wolpert HA. Optimized Mealtime Insulin Dosing for Fat and Protein in Type 1 Diabetes: Application of a Model-Based Approach to Derive Insulin Doses for Open-Loop Diabetes Management. Diabetes Care. 2016 Sep;39(9):1631-4. doi: 10.2337/dc15-2855. Epub 2016 Jul 7.

  PMID: 27388474 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin Lispro

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Howard Wolpert, MD

  Joslin Diabetes Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 22, 2014
• First Posted: September 25, 2014
• Study Start: September 1, 2014
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 26, 2017

Record last verified: 2017-04

Data Sharing

• IPD Sharing: Will not share