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

This study has been completed.
Sponsor:
Collaborator:
Sanofi
Information provided by (Responsible Party):
University of Colorado, Denver
ClinicalTrials.gov Identifier:
NCT01693302
First received: September 9, 2009
Last updated: September 21, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention
Type 1 Diabetes
Other: Insulin

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Timing of Meal Insulin Boluses to Achieve Optimal Postprandial Glycemic Control in Patients With Type 1 Diabetes

Resource links provided by NLM:


Further study details as provided by University of Colorado, Denver:

Primary Outcome Measures:
  • Blood glucose area under the curve [ Time Frame: 9:00am until 1:30pm ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Glucose values one hour after the meal [ Time Frame: 10:30am ] [ Designated as safety issue: No ]
  • Glucose values two hours after the beginning of the meal [ Time Frame: 11:30am ] [ Designated as safety issue: No ]

Enrollment: 23
Study Start Date: August 2007
Study Completion Date: May 2009
Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: -20 minute insulin
Insulin for the meal is given 20 minutes prior to starting the meal.
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.
Other Name: Insulin time
Experimental: 0 minute insulin
Insulin for the meal is given immediately before starting to eat.
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.
Other Name: Insulin time
Experimental: +20 minute insulin
Insulin is given 20 minutes after the start of the meal.
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.
Other Name: Insulin time

Detailed 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.

  Eligibility

Ages Eligible for Study:   12 Years to 30 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01693302

Locations
United States, Colorado
Barbara Davis Center
Aurora, Colorado, United States, 80045
Sponsors and Collaborators
University of Colorado, Denver
Sanofi
Investigators
Principal Investigator: Peter Chase, MD University of Colorado, Denver
  More Information

No publications provided

Responsible Party: University of Colorado, Denver
ClinicalTrials.gov Identifier: NCT01693302     History of Changes
Other Study ID Numbers: 06-0994
Study First Received: September 9, 2009
Last Updated: September 21, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of Colorado, Denver:
Blood Glucose
Meal insulin

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Insulin, Globin Zinc
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 18, 2014