Effectiveness and Safety of an Electronic Medical Record-Integrated Glucose Management System for Inpatient Diabetes Care: A Randomized Controlled Trial

NCT07664293 | Completed DMC

• 2 other identifiers: eGMS_2022FEMH -2022 -C-014;FEMH-2025-C-
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Type 2 Diabetes

Keywords

eGlycemic Management System; in hospital hyperglycemia; Subcutaneous basal bolus insulin protocol

Outcome Measures

Primary Outcomes (1)

• the mean percent of glucose readings between 140 and 180 mg/dL per patient

  Calculated for each patient and averaged across all eligible patients in each study arm

  through study completion, an average of 7 days

Secondary Outcomes (2)

• Glycemic control: patient day weighted mean glucose

  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

  through study completion, an average of 7 days

Study Arms (2)

FEMH Electronic Glucose Management System (FEMH-eGMS)

EXPERIMENTAL

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.

Device: FEMH Electronic Glucose Management System (FEMH-eGMS)

Conventional Basal-Bolus Subcutaneous Insulin Protocol

ACTIVE COMPARATOR

Patients in the control group received insulin injection therapy according to the usual insulin ordering protocol;

Procedure: Control group

Interventions

Control group PROCEDURE

Patients in the control group received insulin injection therapy according to the usual insulin ordering protocol

Conventional Basal-Bolus Subcutaneous Insulin Protocol

FEMH Electronic Glucose Management System (FEMH-eGMS) DEVICE

Inpatient blood glucose control of patients in the interventional group received the dose of insulin injection therapy by suggestion of eGMS.

FEMH Electronic Glucose Management System (FEMH-eGMS)

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Far Eastern Memorial Hospital: lead

Study Sites (1)

Far Eastern Memory Hospital

New Taipei City, 220, Taiwan

Location

Related Publications (5)

• 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.

  PMID: 19140173 BACKGROUND

• 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.

  PMID: 20664017 RESULT

• 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.

  PMID: 20061280 RESULT

• 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.

  PMID: 26355756 RESULT

• 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.

  PMID: 27805455 RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients in the same ward will be randomly assigned by computer in a ratio of 1:1 to the interventional group or the control group.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 1. This study is a randomized controlled trial conducted in the ordinary ward of the Department of Metabolism, Integrative Medicine and General Medicine. Patients in the same ward will be randomly assigned by computer in a ratio of 1:1 to the interventional group or the control group. 2. Patients who meet the inclusion criteria will be referred by the attending physician, and then study P.I. or researcher will explain the trial method, and the research will be carried out after obtaining the patient's consent in writing. The patient does not know that he is assigned to which group. 3. Patients in the control group received insulin injection therapy according to the usual insulin ordering protocol; 4. Inpatient blood glucose control of patients in the interventional group received the dose of insulin injection therapy by suggestion of eGMS.

Study Record Dates

• First Submitted: June 2, 2026
• First Posted: June 24, 2026
• Study Start: April 12, 2023
• Primary Completion: April 23, 2026
• Study Completion: April 23, 2026
• Last Updated: June 24, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: starting in January 2027

Locations

TW (1)