Type 2 Diabetes
Conditions
Keywords
eGlycemic Management System, in hospital hyperglycemia, Subcutaneous basal bolus insulin protocol
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.
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.
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
Sponsors
Far Eastern Memorial Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Intervention 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.
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
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
* 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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| the mean percent of glucose readings between 140 and 180 mg/dL per patient | through study completion, an average of 7 days | Calculated for each patient and averaged across all eligible patients in each study arm |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Glycemic control: patient day weighted mean glucose | through study completion, an average of 7 days | mean glucose level for each patient day |
| 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 | \<70 mg/dL (hypoglycemia), \<54 mg/dL (severe hypoglycemia), and \>300 mg/dL (severe hyperglycemia) |
Countries
Taiwan
Outcome results
None listed