Status unknownNCT05389254Updated May 25, 2022

Association Between Time in Range and In-hospital Outcomes in Type 2 Diabetic Patients With Acute Coronary Syndrome

An interventional study of continuous glucose monitoring system and capillary blood glucose monitoring in Type 2 Diabetes Mellitus and Acute Coronary Syndrome, sponsored by Ningbo No. 1 Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2022-05-25.

Sponsored by Ningbo No. 1 Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2022), so the status shown — last known as Not yet recruiting — may be out of date.

Phase: Not applicable
Study type: Interventional
Enrollment: 100
Allocation: Randomized
Ages: 18 Years to 70 Years
Sex: All

Study summary

The aim of this study is to use real-time continuous glucose monitoring (real-time CGM) system to get a 14-days blood glucose profile of the hospitalized type 2 diabetes mellitus (T2DM) patients with acute coronary syndrome (ACS), and to understand whether time in range (TIR) is associated with in-hospital outcomes of these patients. This study plans to recruit 100 patients. They will be randomly divided into 2 groups: real-time CGM group and capillary blood glucose monitoring group. All enrolled participants will receive standardized blood glucose management according to the "Expert consensus on blood glucose management of inpatients in China". The duration of the study will be 3 months. The primary endpoint is the average hospital stay and cardiac care unit (CCU) occupancy rate in T2DM patients with ACS. The secondary endpoint is a composite endpoint of nonfatal myocardial infarction, acute heart failure, heart failure rehospitalization, coronary revascularization, cardiovascular death, all-cause death.

Conditions studied

Type 2 Diabetes Mellitus
Acute Coronary Syndrome

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In context

Diabetes Mellitus, Type 2

9,589 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,332 are open to participants now.

This study's planned enrollment of 100 is above the median of 81 across 7,713 interventional studies indexed under Diabetes Mellitus, Type 2.

Browse Diabetes Mellitus, Type 2 studies →

Lead sponsor

Ningbo No. 1 Hospital is the lead sponsor of 59 studies on the registry; 12 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 70 Years
Sexes eligible: All
Accepts healthy volunteers: No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

aged ≥18 and ≤70 years old;
T2DM according to 2022 American Diabetes Association standards;
Patients admitted to hospital with either non-ST elevation acute coronary syndrome or ST-elevation myocardial infarction; coronary angiography examination data can be collected;
a stable glucose lowering regimen for the previous 3 months;
obtain informed consent;
with complete clinical data.

Exclusion criteria

Exclusion Criteria:

Diagnosis of other types of diabetes, such as type 1 diabetes, gestational diabetes, secondary diabetes, etc.;
No acute complications of diabetes, such as ketoacidosis, nonketotic hyperosmolar coma, etc.;
Repeated severe hypoglycemia or hyperglycemia in the past 3 months;
Patients who have had a history of allergic reactions to CGM materials or skin adhesives, alcohol or chlorhexidine disinfectants;
Patients who have symptoms and signs of skin lesions, scarring, redness, infection or edema at the sensor application site that can affect the accuracy of sensor application or interstitial fluid glucose measurements;
Combined with other acute disease states, such as uncontrolled severe infection, use of catecholamines or sedatives, use of ventilator, ventricular fibrillation, etc.;
Patients who have a history of hematocrit, platelet, and hemoglobin abnormalities within past 2 months; moderate to severe anemia; or a disease (such as a coagulation disorder) that increases the risk of bleeding;
Patients with malignant tumors, severe liver and kidney diseases, allergic diseases, mental and neurological diseases, combined with rheumatic or immune diseases;
Using drugs that may affect blood sugar, including steroids, psychotropic drugs, anti-AIDS drugs, etc.;
X-ray, CT, MRI examinations are scheduled during the period of wearing the sensor, and the appointment time cannot be changed to the beginning or the end of wearing;
Patients currently participate in another clinical trial;
Unwilling or unwilling to comply with study requirements, poor compliance, or refusal to use real time-CGM.

Study design

Phase: Not applicable
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 100 participants (estimated)

Study arms

Experimental
real-time CGM group
Participants in this group will be implanted with sensors of SISENSING® GS1 continuous glucose monitoring system in their left upper arm within 24 hours after hospitalization. According to the real-time CGM blood glucose data and clinical needs, researchers will carry out individualized in-hospital blood glucose standard management.
Device: continuous glucose monitoring system
Other
Capillary blood glucose monitoring group
Participants in this group will be implanted with sensors of SISENSING® GS1 continuous glucose monitoring system in their left upper arm within 24 hours after hospitalization. But these patients will be blind to the CGM data. They'll receive 8-point capillary blood glucose monitoring simultaneously, which are 6am, 9am, 11am, 1pm, 4pm, 7pm, 9pm, 2am. According to the 8-point glucose data and clinical needs, researchers will carry out individualized in-hospital blood glucose standard management.
Device: capillary blood glucose monitoring

Interventions

Devicecontinuous glucose monitoring system
use real-time CGM system to check and adjust blood glucose
Devicecapillary blood glucose monitoring
monitor blood glucose with finger blood; real-time CGM is blind to both participants and researchers

What researchers measure

Primary outcomes

The average hospital stay
The average hospital stay in hospitalized T2DM patients with ACS.
Time frame: 3 months
The CCU occupancy rate
The CCU occupancy rate in in hospitalized T2DM patients with ACS.
Time frame: 3 months

Secondary outcomes

Major adverse cardiovascular events after 3 months
A composite endpoint of nonfatal myocardial infarction, acute heart failure, heart failure rehospitalization, coronary revascularization, cardiovascular death, all-cause death.
Time frame: 3 months

Study locations

1 site

Ningbo First Hospital
Ningbo, Zhejiang 315000, China
- Li Li, Bachelor · Contact · lilyningbo@163.com · 8613757426626

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

Timeline

Tracking since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2022; primary completion for Jun 2023, 12 months later.

Of 1,924 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 39. This study's planned 12 months is below that.

Counting every sponsor, half of 2,101 studies reached it within 20 months; a quarter within 10 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered: May 17, 2022
First posted: May 25, 2022
StartEst.: Jun 2022
Primary completionEst.: Jun 2023
CompletionEst.: Dec 2023
Last update: May 25, 2022

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on May 25, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05389254
Lead sponsor: Ningbo No. 1 Hospital
Responsible party: Sponsor
First posted: May 25, 2022
Start date: Jun 2022 (estimated)
Primary completion: Jun 2023 (estimated)
Completion: Dec 2023 (estimated)
Last update: May 25, 2022

Study contacts

Li Li, Bachelor

Contact

lilyningbo@163.com

8613757426626

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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