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

Primary Purpose

Type 1 Diabetes

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Insulin

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring Blood Glucose, Meal insulin

Eligibility Criteria

12 Years - 30 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Barbara Davis Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

-20 minute insulin

0 minute insulin

+20 minute insulin

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

Blood glucose area under the curve

Secondary Outcome Measures

Glucose values one hour after the meal

Glucose values two hours after the beginning of the meal

Full Information

NCT ID

NCT01693302

First Posted

September 9, 2009

Last Updated

September 21, 2012

Sponsor

University of Colorado, Denver

Collaborators

Sanofi

1. Study Identification

Unique Protocol Identification Number

NCT01693302

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2012

Overall Recruitment Status

Completed

Study Start Date

August 2007 (undefined)

Primary Completion Date

May 2009 (Actual)

Study Completion Date

May 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University of Colorado, Denver

Collaborators

Sanofi

4. Oversight

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes

Keywords

Blood Glucose, Meal insulin

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

23 (Actual)

8. Arms, Groups, and Interventions

Arm Title

-20 minute insulin

Arm Type

Experimental

Arm Description

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

Arm Title

0 minute insulin

Arm Type

Experimental

Arm Description

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

Arm Title

+20 minute insulin

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Insulin

Other Intervention Name(s)

Insulin time

Intervention Description

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.

Primary Outcome Measure Information:

Title

Blood glucose area under the curve

Time Frame

9:00am until 1:30pm

Secondary Outcome Measure Information:

Title

Glucose values one hour after the meal

Time Frame

10:30am

Title

Glucose values two hours after the beginning of the meal

Time Frame

11:30am

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

30 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Peter Chase, MD

Organizational Affiliation

University of Colorado, Denver

Official's Role

Principal Investigator

Facility Information:

Facility Name

Barbara Davis Center

City

Aurora

State/Province

Colorado

ZIP/Postal Code

80045

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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