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

Type 1 Diabetes Clinical Trial

Official title:

Timing of Meal Insulin Boluses to Achieve Optimal Postprandial Glycemic Control in Patients With Type 1 Diabetes

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01693302
• Other study ID #: 06-0994
• Status: Completed
• Phase: N/A
• First received: September 9, 2009
• Last updated: September 21, 2012
• Start date: August 2007
• Est. completion date: May 2009

Study information

• Verified date: September 2012
• Source: University of Colorado, Denver
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Description:

Subjects enrolled in this study will be between the ages of 12 and 30 years inclusive. All subjects will be on an insulin pump and use carbohydrate counting as their method for insulin dosing at a meal.

Subjects in this study will complete three study visits lasting from approximately 8:30am until 1:30pm. At each visit, the subject will eat the same frozen breakfast meal. Subjects will be supplied with the same insulin to maintain consistency between visits and between subjects.

Insulin will be administered at different times, depending upon the randomization group assigned to the participant. The three different times the insulin will be given is either 20 minutes before the meal, immediately before the meal and 20 minutes after the meal. All subjects will complete all three insulin bolus times. Blood glucose will be measured by fingerstick every 30 minutes until the completion of the visit.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 23
• Est. completion date: May 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 30 Years

Eligibility

Inclusion Criteria:

• 12 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

Exclusion Criteria:

• 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

Study Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Other:
• Insulin
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.

Locations

Country	Name	City	State
United States	Barbara Davis Center	Aurora	Colorado

Sponsors (2)

Lead Sponsor	Collaborator
University of Colorado, Denver	Sanofi

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood glucose area under the curve		9:00am until 1:30pm	No
Secondary	Glucose values one hour after the meal		10:30am	No
Secondary	Glucose values two hours after the beginning of the meal		11:30am	No