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NCT Number: NCT07664293

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

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Far Eastern Memory Hospital

New Taipei City, 220, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Control Group

Procedure

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Glycemic control: patient day weighted mean glucose

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

    mean glucose level for each patient day

  2. 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)

Sponsors and collaborators

Lead sponsor

Far Eastern Memorial Hospital

Other

Registry information

Official study title

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

Acronym: FEMH-eGMS

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 24, 2026
Registry last updated
Jun 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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