Type 2 DiabetesFEMH-eGMSNCT07664293
Effectiveness and Safety of an Electronic Medical Record-Integrated Glucose Management System for Inpatient Diabetes Care: A Randomized Controlled Trial
A study testing FEMH Electronic Glucose Management System (FEMH-eGMS) in people with Type 2 Diabetes, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
Trial 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 more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- FEMH Electronic Glucose Management System (FEMH-eGMS)
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteTaiwan
- Study dates
- 12 Apr 2023to 23 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official 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
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.
- Conditions
- Type 2 Diabetes
- Being tested
- FEMH Electronic Glucose Management System (FEMH-eGMS), Control group
- Keywords
- eGlycemic Management System, in hospital hyperglycemia, Subcutaneous basal bolus insulin protocol
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 groupProcedure or surgery
Patients in the control group received insulin injection therapy according to the usual insulin ordering protocol
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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; Receives: Procedure: Control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: through study completion, an average of 7 days
Secondary outcomes (2)
Glycemic control: patient day weighted mean glucose
mean glucose level for each patient day
Measured: 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
<70 mg/dL (hypoglycemia), <54 mg/dL (severe hypoglycemia), and >300 mg/dL (severe hyperglycemia)
Measured: through study completion, an average of 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start12 Apr 2023
- Primary completion23 Apr 2026
- Study completion23 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 140 participants (actual)
Sponsor and investigators
- Lead sponsor
- Far Eastern Memorial Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664293
- Sponsor's protocol ID
- eGMS_2022
- Other IDs
- FEMH -2022 -C-014;FEMH-2025-C-
- Acronym
- FEMH-eGMS
- Status last verified
- May 2026
- First submitted
- 2 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: all IPD that underlie results in a publication
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 19140173Wexler 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 20664017Schnipper 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 20061280Neubauer 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 26355756Sinha 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 at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07664293
- Acronym / sponsor ID
- FEMH-eGMS / eGMS_2022
- Conditions
- Type 2 Diabetes
- Keywords
- eGlycemic Management System, in hospital hyperglycemia, Subcutaneous basal bolus insulin protocol
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 140 participants (actual)
- Lead sponsor
- Far Eastern Memorial HospitalUniversity, hospital or other
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 23 Apr 2026 (actual)
- Study completion
- 23 Apr 2026 (actual)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| FEMH Electronic Glucose Management System (FEMH-eGMS) | Experimental | Device: 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. |
| Conventional Basal-Bolus Subcutaneous Insulin Protocol | Active comparator | Procedure: Control groupPatients in the control group received insulin injection therapy according to the usual insulin ordering protocol; |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- Type 1 diabetes mellitus
- Pregnancy
- Gestational diabetes
- Hyperosmolar hyperglycemic state or diabetic ketoacidosis at admission
- Total parenteral nutrition
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FEMH 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. | Device | FEMH Electronic Glucose Management System (FEMH-eGMS) |
| Control groupPatients in the control group received insulin injection therapy according to the usual insulin ordering protocol | Procedure or surgery | Conventional Basal-Bolus Subcutaneous Insulin Protocol |
Primary outcome
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
2 secondary outcomes
Glycemic control: patient day weighted mean glucose
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2026.
- Background: PubMed 19140173Maynard 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.
- Results publication: PubMed 20664017Wexler 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.
- Results publication: PubMed 20061280Schnipper 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.
- Results publication: PubMed 26355756Neubauer 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.
- Results publication: PubMed 27805455Sinha 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.
- Individual participant dataSharing planned: Yes. all IPD that underlie results in a publication
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FEMH Electronic Glucose Management System (FEMH-eGMS) in people with Type 2 Diabetes, run by Far Eastern Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the mean percent of glucose readings between 140 and 180 mg/dL per patient (time frame: through study completion, an average of 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07664293, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2026.