Back to resultsAssociation Between Time in Range and In-hospital Outcomes in Type 2 Diabetic Patients With Acute Coronary Syndrome
Primary Purpose
Type 2 Diabetes Mellitus, Acute Coronary Syndrome
Status
Not yet recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
continuous glucose monitoring system
capillary blood glucose monitoring
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
Eligibility Criteria
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:
- 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.
Sites / Locations
- Ningbo First Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
real-time CGM group
Capillary blood glucose monitoring group
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
The average hospital stay
The average hospital stay in hospitalized T2DM patients with ACS.
The CCU occupancy rate
The CCU occupancy rate in in hospitalized T2DM patients with ACS.
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05389254
Brief Title
Association Between Time in Range and In-hospital Outcomes in Type 2 Diabetic Patients With Acute Coronary Syndrome
Official Title
Association Between Time in Range and In-hospital Outcomes in Type 2 Diabetes Mellitus Patients With Acute Coronary Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 2022 (Anticipated)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
December 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ningbo No. 1 Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus, Acute Coronary Syndrome
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
real-time CGM group
Arm Type
Experimental
Arm Description
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.
Arm Title
Capillary blood glucose monitoring group
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
continuous glucose monitoring system
Intervention Description
use real-time CGM system to check and adjust blood glucose
Intervention Type
Device
Intervention Name(s)
capillary blood glucose monitoring
Intervention Description
monitor blood glucose with finger blood; real-time CGM is blind to both participants and researchers
Primary Outcome Measure Information:
Title
The average hospital stay
Description
The average hospital stay in hospitalized T2DM patients with ACS.
Time Frame
3 months
Title
The CCU occupancy rate
Description
The CCU occupancy rate in in hospitalized T2DM patients with ACS.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Major adverse cardiovascular events after 3 months
Description
A composite endpoint of nonfatal myocardial infarction, acute heart failure, heart failure rehospitalization, coronary revascularization, cardiovascular death, all-cause death.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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:
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Li Li, Bachelor
Phone
8613757426626
Email
lilyningbo@163.com
Facility Information:
Facility Name
Ningbo First Hospital
City
Ningbo
State/Province
Zhejiang
ZIP/Postal Code
315000
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Li Li, Bachelor
Phone
8613757426626
Email
lilyningbo@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Association Between Time in Range and In-hospital Outcomes in Type 2 Diabetic Patients With Acute Coronary Syndrome
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