Effectiveness and Safety of an Electronic Medical Record-Integrated Glucose Management System for Inpatient Diabetes Care: A Randomized Controlled Trial (FEMH-eGMS)
Comparison of the Safety and Efficacy of the Far Eastern Memorial Hospital Electronic Glucose Management System (eGMS) With Conventional Subcutaneous Basal-Bolus Insulin Protocol in Ordinary Ward Patients: A Prospective Randomized Controlled Trial
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Both inpatient hyperglycemia and hypoglycemia increase the adverse effects of ordinary ward patients, including mortality rate, so the American Diabetes Association recommends that the blood glucose target for inpatients is 140 to 180 mg/dL. Previous studies found that the use of electronic glucose management system (eGMS) could increase the achievement of the goal. Currently, there are several eGMS on the market, such as Glucommander（Glytec，Greenville，SC）、EndoTool System（MD Scientific LLC，Charlotte，NC） and GlucoStabilizer（Medical Decision Network，Charlottesville，VA）, although they were proved to improve in blood glucose management in hospitals, nurses still need to manually enter clinical parameters and each blood glucose data, causing a burden on medical staff.
Neither Glucommander nor EndoTool system considered vital signs, intravenous and partial intravenous nutrition infusion, diagnosis of hepatic, renal and heart failure, which would also affect the level of blood glucose. To our best knowledge, no similar eGMS has been developed in Asia or Taiwan. Our hospital is about to develop an easy-to-operate eGMS. This system can automatically obtain the patient's demographic characteristics, vital signs, daily diet and intake status, usage of anti-diabetic agents or other medications that affect the level of blood glucose, the ICD codes of hypoglycemia risk factors, and laboratory test results from the electronic medical records of the hospital. There is no need to manually input by the medical staff, and the recommended insulin dose will be updated and calculated continuously. The FEMH eGMS study will be developed in Feb. 2022.
The purpose of this study is to compare the eGMS designed by FEMH with the usual insulin ordering protocol in the safety and efficacy of subcutaneous insulin therapy in ordinary ward.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
New Taipei City, Taiwan, 220
- Far Eastern Memory Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Age ≥ 20 years
- Type 2 diabetes mellitus
- Required four-times-daily subcutaneous basal-bolus insulin during admission
- At least two point-of-care glucose readings >180 mg/dL during admission
Exclusion Criteria:
- Type 1 diabetes mellitus
- Pregnancy
- Gestational diabetes
- Hyperosmolar hyperglycemic state or diabetic ketoacidosis at admission
- Total parenteral nutrition
- Treatment with intravenous insulin infusion (insulin pump)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: FEMH Electronic Glucose Management System (FEMH-eGMS)
An EMR-integrated clinical decision support tool that automatically retrieves demographic, dietary, antidiabetic medication, comorbidity (ICD-coded hypoglycemia risk factors), laboratory, and glucose data directly from the hospital electronic medical record without manual entry. The system computes a recommended total daily subcutaneous insulin dose using a weight- and HbA1c-adjusted algorithm, partitioned into 50% basal (long-acting) and 50% prandial (rapid-acting, divided across three meals), with a correction-dose component for premeal hyperglycemia. Dose recommendations are continuously updated as new clinical data become available. The treating physician reviews each recommendation before order entry. |
Inpatient blood glucose control of patients in the interventional group received the dose of insulin injection therapy by suggestion of eGMS.
|
|
Active Comparator: Conventional Basal-Bolus Subcutaneous Insulin Protocol
Patients in the control group received insulin injection therapy according to the usual insulin ordering protocol;
|
Patients in the control group received insulin injection therapy according to the usual insulin ordering protocol
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
the mean percent of glucose readings between 140 and 180 mg/dL per patient
Time Frame: through study completion, an average of 7 days
|
Calculated for each patient and averaged across all eligible patients in each study arm
|
through study completion, an average of 7 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Glycemic control: patient day weighted mean glucose
Time Frame: through study completion, an average of 7 days
|
mean glucose level for each patient day
|
through study completion, an average of 7 days
|
|
Patient safety: proportion of patient-days with any glucose reading <70 mg/dL, <54 mg/dL, and >300 mg/dL
Time Frame: through study completion, an average of 7 days
|
<70 mg/dL (hypoglycemia), <54 mg/dL (severe hypoglycemia), and >300 mg/dL (severe hyperglycemia)
|
through study completion, an average of 7 days
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Maynard G, Lee J, Phillips G, Fink E, Renvall M. Improved inpatient use of basal insulin, reduced hypoglycemia, and improved glycemic control: effect of structured subcutaneous insulin orders and an insulin management algorithm. J Hosp Med. 2009 Jan;4(1):3-15. doi: 10.1002/jhm.391.
- Wexler DJ, Shrader P, Burns SM, Cagliero E. Effectiveness of a computerized insulin order template in general medical inpatients with type 2 diabetes: a cluster randomized trial. Diabetes Care. 2010 Oct;33(10):2181-3. doi: 10.2337/dc10-0964. Epub 2010 Jul 27.
- Schnipper JL, Liang CL, Ndumele CD, Pendergrass ML. Effects of a computerized order set on the inpatient management of hyperglycemia: a cluster-randomized controlled trial. Endocr Pract. 2010 Mar-Apr;16(2):209-18. doi: 10.4158/EP09262.OR.
- Neubauer KM, Mader JK, Holl B, Aberer F, Donsa K, Augustin T, Schaupp L, Spat S, Beck P, Fruhwald FM, Schnedl C, Rosenkranz AR, Lumenta DB, Kamolz LP, Plank J, Pieber TR. Standardized Glycemic Management with a Computerized Workflow and Decision Support System for Hospitalized Patients with Type 2 Diabetes on Different Wards. Diabetes Technol Ther. 2015 Oct;17(10):685-92. doi: 10.1089/dia.2015.0027. Epub 2015 Jun 5.
- Sinha Gregory N, Seley JJ, Gerber LM, Tang C, Brillon D. Decreased rates of hypoglycemia following implementation of a comprehensive computerized insulin order set and titration algorithm in the inpatient setting. Hosp Pract (1995). 2016 Dec;44(5):260-265. doi: 10.1080/21548331.2016.1250603. Epub 2016 Nov 2.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- eGMS_2022
- FEMH -2022 -C-014;FEMH-2025-C- (Other Grant/Funding Number: Far Eastern Memorial Hospital)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.