Timing of Insulin Before Meals Everyday (TIME)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00789945|
Recruitment Status : Completed
First Posted : November 13, 2008
Last Update Posted : April 5, 2013
|Condition or disease||Intervention/treatment||Phase|
|Type 1 Diabetes||Other: Control Other: Study Arm B||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Factorial Assignment|
|Masking:||Double (Investigator, Outcomes Assessor)|
|Official Title:||The Importance of Insulin Timing in Type 1 Diabetes|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||December 2011|
|Actual Study Completion Date :||December 2011|
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.
- To determine the changes in A1C. [ Time Frame: 8 months ]
- To determine changes in postprandial glucose excursion during the meal's 5 hour postprandial period. [ Time Frame: 8 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00789945
|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|