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The Effects of SGC on Glucose Control in Critically Ill Patients With Sepsis

Comparing SGC and Conventional Empiric Treatment for Glucose Control in Critically Ill Patients With Sepsis in ICU

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02980588
Enrollment
60
Registered
2016-12-02
Start date
2016-12-31
Completion date
2017-09-30
Last updated
2016-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Illness, Hyperglycemia, Sepsis

Brief summary

Poorly glycemic control in critically ill patients can increase their mortality, while safe and efficient glucose control is laborious and time-consuming. The Space Glucose Control which is installed with eMPC(enhanced Model Predictive Control) can get the blood glucose target range safely and effectively through regulating insulin dose rate, and decrease the glucose variability. This study is a random controlled trial involving the patients with sepsis in intensive care unit in order to evaluate the difference of safety and efficacy of blood glucose control between SGC directed and conventional treatment. At last, the trial results can determine whether the Space Glucose Control can control blood glucose safely and effectively in the patients with sepsis in intensive care units.

Detailed description

Design: The study was conducted as a single-centre, open randomized controlled, parallel trial. Study population: Adult general ICU patients with sepsis and assumed to require at least 3 days of intensive care were recruited. Patients fulfilling the inclusion criterion of glucose≥9.0 mmol/L were randomly assigned using serially numbered to either the intervention group (BG control by SGC) or the control group (conventional empiric BG management). The both group aim to establish the BG levels 5.8-8.9mmol/L. Study protocol: BG measurements were performed using glucometer to test the fingertip capillary blood sample for the BG levels. As for patients with shock or required vasopressor, arterial BG was sampled to measure through the glucometer. Insulin was infused intravenously applying the standard perfusor of the ICU. Average glucose, glucose variability, SOFA score, APACHE II score, and HLA-DR were recorded. All trial-related activities were carried out until the end of the patient's ICU stay, or for a period of 72 hours. Meanwhile, enteral and parenteral nutrition was administrated to patients according to their condition. Statistical analysis was performed on an intention-to-treat basis. The percentage of values in the target range (5.8-8.9mmol/L) was defined as primary end point for the assessment of glucose control. Data are reported as mean±SD values if not otherwise indicated. Data analysis was performed using SPSS19.0.

Interventions

the patients' blood glucose is controlled by SGC system through insulin continuous infusion whose dosage is determinated by SGC

Sponsors

Southeast University, China
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Admitted to the ICU 2. At least one BG measurement 9.0mmol/L or higher 3. Expected to stay in ICU ≥3 days; 4. critically ill patients with sepsis 5. SOFA score≤2

Exclusion criteria

1. Aged \< 18 years; 2. Admitted because of diabetic ketoacidosis or nonketotic hyperosmolar state 3. Pregnant 4. In a state in which death was perceived as imminent 5. Without written informed consent

Design outcomes

Primary

MeasureTime frameDescription
glucose variabilityup to 3daysmean blood glucose, standard deviation (SD) for the mean glucose,minimum and maximum glucose levels

Secondary

MeasureTime frame
HLADrup to 3days

Contacts

Primary ContactMin Mo, Doctor
momin_2002@163.com13914719904

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026