Timing of Meal Insulin Boluses for Optimal Postprandial Glycemic Control in Type 1 Diabetes

NCT01693302 | Completed

• 1 other identifier: 06-0994
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

Blood glucose levels in patients with type 1 diabetes tend to peak after eating a meal due to the delayed action of insulin when compared to carbohydrate absorption from food. It is the hypothesis of the investigator that administering the insulin for a meal 20 minutes before the meal will result in lower blood glucose peaks compared to administration of insulin immediately before or 20 minutes after starting to eat. All subjects will eat the same meal on three different occasions. Insulin will be administered at one of the three times at each visit.

Conditions

Type 1 Diabetes

Keywords

Blood Glucose; Meal insulin

Outcome Measures

Primary Outcomes (1)

• Blood glucose area under the curve

  9:00am until 1:30pm

Secondary Outcomes (2)

• Glucose values one hour after the meal

  10:30am

• Glucose values two hours after the beginning of the meal

  11:30am

Study Arms (3)

-20 minute insulin

EXPERIMENTAL

Insulin for the meal is given 20 minutes prior to starting the meal.

Other: Insulin

0 minute insulin

EXPERIMENTAL

Insulin for the meal is given immediately before starting to eat.

Other: Insulin

+20 minute insulin

EXPERIMENTAL

Insulin is given 20 minutes after the start of the meal.

Other: Insulin

Interventions

Insulin OTHER

The timing of insulin delivery varies with each study visit. The dose is given based on carbohydrate content and blood glucose level. The insulin is given either 20 minutes before the meal, immediately before the meal, or 20 minutes after the meal.

Also known as: Insulin time

+20 minute insulin; -20 minute insulin; 0 minute insulin

Eligibility Criteria

• Age: 12 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• to 30 years of age, inclusive
• Clinical diagnosis of T1D and using daily insulin therapy for at least 1 year
• Using carbohydrate counting to dose meal time insulin
• HbA1c value upon enrollment greater than 6.0% and less than 12.0%
• Using CSII therapy for diabetes management for at least three months
• Able and willing to give informed consent/assent to participate
• No expectation that the subject will be moving out of the area of the clinical center during the study
• Willing to consume the same standard frozen meal on all three visits

You may not qualify if:

• The presence of a significant medical disorder that in the judgment of the investigator will affect the wearing of the CGMS sensors or the completion of any aspect of the protocol
• Being unable or unwilling to give informed consent
• Having documented hypoglycemia unawareness
• An episode of severe hypoglycemia (seizure or loss of consciousness) or of ketoacidosis in the past six months

Sponsors & Collaborators

• University of Colorado, Denver: lead
• Sanofi: collaborator

Study Sites (1)

Barbara Davis Center

Aurora, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Interventions

Insulin

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)

Proinsulin; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Peter Chase, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: September 9, 2009
• First Posted: September 26, 2012
• Study Start: August 1, 2007
• Primary Completion: May 1, 2009
• Study Completion: May 1, 2009
• Last Updated: September 26, 2012

Record last verified: 2012-09

Locations

US (1)