Timing of Insulin Before Meals Everyday (TIME)
The inclusion of "Timing of premeal insulin administration (Timing)" in an Intensive Insulin Therapy regimen will reduce A1C by an average of 1% in type 1 diabetic patients who have initial A1C's between 7.0% and 9.0%.
|Study Design:||Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||The Importance of Insulin Timing in Type 1 Diabetes|
- To determine the changes in A1C. [ Time Frame: 8 months ] [ Designated as safety issue: No ]
- To determine changes in postprandial glucose excursion during the meal's 5 hour postprandial period. [ Time Frame: 8 months ] [ Designated as safety issue: No ]
|Study Start Date:||December 2008|
|Study Completion Date:||December 2011|
|Primary Completion Date:||December 2011 (Final data collection date for primary outcome measure)|
Placebo Comparator: Study Arm A
Study Arm A will be the primary control arm.
Study Arm A will consist of patients with Type 1 diabetes who will continue their current intensive insulin therapy regimen with no additional interventions by the investigators. Their primary care providers will continue to manage their diabetes to obtain the best control as possible of their glucose, lipids, and blood pressure. Continuous Glucose Monitoring will be monitored. No timing of premeal insulin administration will be utilized in this arm.
Other Name: Control group- No "timing" insulin administartion.
Experimental: Study Arm B
Study Arm B will serve as the intervention arm.
Other: Study Arm B
Study Arm B will include participants with type 1 diabetes which will utilize "Timing" to adjust their pre-meal insulin dosages. Participants will continue taking their current insulin and will be placed on a continuous glucose monitor.
Other Name: Intervention- "Timing" of insulin administration.
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|United States, New Mexico|
|University of New Mexico, Health Sciences Center|
|Albuquerque, New Mexico, United States, 87131|
|Principal Investigator:||David S Schade, MD||University of New Mexico, Health Sciences Center|