Simplified Insulin Protocol Using Lantus in Elderly (SIMPLE)
The purpose of this study is to find out if simplifying your diabetes treatment by decreasing number of insulin injections, with the help of a long acting insulin called glargine, can decrease the episodes of low blood glucose.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Simplification of Diabetes Regimen in Elderly Patients Using Glargine|
- Change in frequency and duration of hypoglycemia episodes [ Time Frame: baseline, 5 months, 8 months ] [ Designated as safety issue: Yes ]frequency and duration of hypoglycemia measured by continuous glucose monitoring
|Study Start Date:||June 2011|
|Estimated Study Completion Date:||July 2015|
|Estimated Primary Completion Date:||July 2015 (Final data collection date for primary outcome measure)|
We plan to add long acting insulin glargine with/without oral medications to the regimen in all patients.
Use of glargine with/without other glucose lowering agent to simplify insulin regimen in older adults
As patients with diabetes age, adverse social and medical problems may arise. Because of these problems patients, even those managing their diabetes for many years, find it difficult to continue with complicated insulin schedules. This may lead to errors in treatment and poor glucose control. Simplification of treatment has been found to the decrease risk of low blood glucose, a very dangerous condition at this age. In a previous study, the investigators found that simplifying treatment did not cause the blood sugars to rise out of control. In this study, the investigators plan to simplify insulin treatment and monitor for low glucose episodes with help of a continuous glucose monitor and A1C (measure of average glucose control over 3 months). The investigators will simplify the treatment by adding glucose lowering medications that you can take by mouth, in addition to the injection of long acting insulin called glargine.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01480843
|United States, Massachusetts|
|Joslin Diabetes Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Medha N Munshi, MD||Joslin Diabetes Center|