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CompletedNCT07664293FEMH-eGMSUpdated Jun 24, 2026

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

An interventional study of FEMH Electronic Glucose Management System (FEMH-eGMS) and Control group in Type 2 Diabetes, sponsored by Far Eastern Memorial Hospital. Completed at 1 site in Taiwan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2026-06-24.

Sponsored by Far Eastern Memorial Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 1 month after the study started (first participant enrolled Apr 2023, registered Jun 2026).
Phase
Not applicable
Study type
Interventional
Enrollment
140
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Type 2 Diabetes

Keywords

  • eGlycemic Management System
  • in hospital hyperglycemia
  • Subcutaneous basal bolus insulin protocol
03

In context

Diabetes Mellitus, Type 2

9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.

This study's enrollment of 140 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Far Eastern Memorial Hospital is the lead sponsor of 253 studies on the registry; 38 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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)
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
140 participants (actual)

Study arms

  • 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.

    Device: FEMH Electronic Glucose Management System (FEMH-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;

    Procedure: Control group

Interventions

  • DeviceFEMH Electronic Glucose Management System (FEMH-eGMS)

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

  • ProcedureControl group

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

06

What researchers measure

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

    Time frame: through study completion, an average of 7 days

Secondary outcomes

  1. Glycemic control: patient day weighted mean glucose

    mean glucose level for each patient day

    Time frame: through study completion, an average of 7 days

  2. Patient safety: proportion of patient-days with any glucose reading <70 mg/dL, <54 mg/dL, and >300 mg/dL

    \<70 mg/dL (hypoglycemia), \<54 mg/dL (severe hypoglycemia), and \>300 mg/dL (severe hyperglycemia)

    Time frame: through study completion, an average of 7 days

07

Study locations

1 site
  • Far Eastern Memory Hospital
    New Taipei City, 220, Taiwan
08

References and documents

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. PubMed 19140173 ↗
  • 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. PubMed 20664017 ↗
  • 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. PubMed 20061280 ↗
  • 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. PubMed 26355756 ↗
  • 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. PubMed 27805455 ↗

Study documents

  • Study protocol · Aug 14, 2025

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — all IPD that underlie results in a publication

Supporting information: Study protocol, Csr

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07664293
Lead sponsor
Far Eastern Memorial Hospital
Responsible party
Sponsor
First posted
Jun 24, 2026
Start date
Apr 12, 2023
Primary completion
Apr 23, 2026
Completion
Apr 23, 2026
Last update
Jun 24, 2026

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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