An interventional study of Real-time continuous glucose monitoring（rtCGM） and Point-of-care blood glucose testing (POCT) in Stress Hyperglycemia and Perioperative Hyperglycemia, sponsored by Sinocare. Not yet recruiting. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-11-12.
Sponsored by Sinocare · Not applicable, Interventional, and Treatment
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This is a single-center, prospective, open-label, 1:1 randomized parallel-controlled investigator-initiated trial. A total of 120 adult patients with abnormal glucose undergoing elective or semi-elective non-emergency general or orthopedic surgery will be enrolled. Subjects are randomized to rtCGM-guided perioperative glycemic management (experimental group) or conventional POCT-only glycemic management (control group, using blinded rtCGM sensor for post-hoc data collection). The primary endpoint is hierarchical composite of postoperative length-of-stay and CGM Time-In-Range analyzed by win-ratio. Secondary objectives include glycemic metrics, rtCGM accuracy, postoperative complications, hypoglycemia/hyperglycemia events, health-economic indexes and satisfaction assessments. Safety including adverse events and device-related reactions will be descriptively evaluated. Follow-up includes in-hospital monitoring plus telephone follow-up 30 days after surgery.
Diabetes and stress hyperglycemia are common among perioperative surgical patients and are associated with higher risks of postoperative infection, complications and prolonged hospital stay. Real-time continuous glucose monitoring (rtCGM) can capture continuous interstitial glucose data including asymptomatic hypo- and hyperglycemia, which may optimize perioperative glycemic control. This single-center, prospective, open-label, randomized parallel-controlled trial aims to compare perioperative glycemic management guided by real-time continuous glucose monitoring versus conventional point-of-care capillary glucose testing (POCT) among adults with abnormal glucose receiving non-emergency elective or semi-elective general or orthopedic surgery. One-hundred-twenty eligible subjects will be randomized 1:1 into experimental rtCGM group or POCT control group. Experimental group uses visible rtCGM (Sinocare iCan h6) as main monitoring tool, supplemented by POCT when clinically indicated. Control group wears blinded rtCGM sensor (data and alarms disabled for clinical use) and is managed exclusively by routine POCT finger-stick glucose. Both groups target perioperative glucose 5.6-10.0 mmol/L, and clinical treatment including anti-hyperglycemic drugs and surgical procedures follows standard hospital practice without protocol-mandated modifications. Primary endpoint is hierarchical composite of postoperative length of hospital stay (first priority) and CGM Time-In-Range (TIR, second priority), evaluated with win-ratio analysis. Secondary endpoints cover multiple glycemic variability indices, rtCGM accuracy metrics (MARD, Clarke error grid, Bland-Altman), postoperative complication rates, hypoglycemia and severe metabolic event rates, 30-day unplanned readmission / emergency visit rates, total hospitalization costs, patient and healthcare-worker satisfaction. Safety assessment collects all adverse events, serious adverse events and device-related adverse reactions up to 30 days post-surgery. Study includes screening/baseline period, perioperative in-hospital intervention period, discharge visit, and post-operative 30-day ±3-day telephone follow-up. Statistical analysis will adopt full analysis set (FAS) as primary population; per-protocol set (PPS) and safety set (SS) will also be analyzed.
801 studies on the registry are indexed under Hyperglycemia; 115 are open to participants now.
This study's planned enrollment of 120 is above the median of 50 across 621 interventional studies indexed under Hyperglycemia.
Browse Hyperglycemia studies →Sinocare is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants use real-time continuous glucose monitoring (rtCGM) for perioperative glycemic management, with glucose alerts and real-time glucose data available to clinicians.
Device: Real-time continuous glucose monitoring（rtCGM）
Participants receive conventional point-of-care blood glucose testing. A blinded CGM sensor is worn for data collection only; glucose values are not accessible to clinical staff.
Device: Point-of-care blood glucose testing (POCT)
Real-time continuous glucose monitoring is used during the perioperative period. Clinicians can view live glucose readings and alerts to guide glycemic adjustment.
Perioperative glycemic management is performed with routine point-of-care blood glucose testing. Participants wear a blinded CGM sensor only for research data collection; real-time glucose data and alerts are not available to the clinical team for treatment decisions.
Hierarchical composite endpoint of postoperative length of hospital stay and CGM-derived time in range (TIR)
Hierarchical rank-based composite endpoint assessed by win-ratio analysis (Finkelstein-Schoenfeld method). First priority: postoperative length of hospital stay, defined as integer days from the day of surgery to discharge (discharge day is excluded from counting). Second priority: CGM-derived percentage time in range (TIR), glucose within 5.6-10.0 mmol/L, only compared for participant pairs tied at the first-priority endpoint.
Time frame: From the day of surgery until hospital discharge, whichever comes first, assessed up to 30 days
No study locations are listed for this record.
Start is estimated for Nov 2026; primary completion for Apr 2027, 5 months later.
Of 225 interventional studies with no phase under Hyperglycemia, half reached primary completion within 14 months of starting (the median), counting those still running; a quarter within 7 and three quarters within 27. This study's planned 5 months is below that.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Nov 2026. You cannot join it, but the record below documents what was studied.
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