Ignite Creation Date:
2024-05-06 @ 9:15 AM
Last Modification Date:
2024-10-26 @ 12:11 PM
Study NCT ID:
NCT02930044
Status:
COMPLETED
Last Update Posted:
2022-04-01
First Post:
2016-09-14
Brief Title:
Early Subcutaneous Insulin Glargine Plus Standard of Care for Treatment of Diabetic Ketoacidosis
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Prospective Comparison of Early Subcutaneous Insulin Glargine Plus Standard of Care Versus Standard of Care for Treatment of Diabetic Ketoacidosis in the Emergency Department
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine whether adult DKA patients who present to the emergency department treated with early subcutaneous long acting insulin versus standard care receive a shorter total duration of intravenous IV insulin infusion
Detailed Description:
Specific Aims To evaluate the impact of early administration of subcutaneous glargine versus standard care on time of insulin infusion in DKA patients and other secondary outcomes listed in this application
Methods DKA patients enrolled in this study will receive the long acting glargine dose 03 unitskg with a maximum dose of 30 units within two hours after initiation the IV insulin infusion Besides timing of the glargine dose no other changes in standard patient care will occur in those patients enrolled in this study the same labs will be collected and the insulin infusion will be titrated using the same hospital protocol algorithm
Patients enrolled in the prospective arm will be compared with the retrospective control group which received standard insulin therapy subcutaneous insulin glargine administered at least 2 to 3 hours prior to termination of the insulin infusion There will be 18 patients in this group selected in reverse chronological order from our pre-specified date range of 812014 to 7312016
Methods DKA patients enrolled in this study will receive the long acting glargine dose 03 unitskg with a maximum dose of 30 units within two hours after initiation the IV insulin infusion Besides timing of the glargine dose no other changes in standard patient care will occur in those patients enrolled in this study the same labs will be collected and the insulin infusion will be titrated using the same hospital protocol algorithm
Patients enrolled in the prospective arm will be compared with the retrospective control group which received standard insulin therapy subcutaneous insulin glargine administered at least 2 to 3 hours prior to termination of the insulin infusion There will be 18 patients in this group selected in reverse chronological order from our pre-specified date range of 812014 to 7312016
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None