- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04164784
Effect of "Therapeutic Monitoring" on Blood Glucose Control in Type 2 Diabetes
Evaluate the Effect of "Therapeutic Monitoring"(Flash Continuous Glucose Monitoring System)on Blood Glucose Control in Type 2 Diabetes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
In our study, about 480 type 2 diabetes patients will be enrolled from multiple centers in China. All participants will be randomly assigned into either the intervention group or the control group. All patients will be given basic diet, lifestyle instruction according to guidelines from home and abroad. The intervention group will be instructed to adjust the diet according to the ambulatory glucose profile (AGP) and the recorde log monitored by the continuous glucose monitoring system, thereby implementing "therapeutic monitoring". All patients will maintain the drug treatment unchanged and make the glucose level as far as possible within the target range (>3.9 and ≤10mmol/L), and record the amount of various food, then maintain the dietary pattern and the amount unchanged until the end of the study.
The primary objective is to evaluate the effects of "therapeutic monitoring" on blood glucose control in type 2 diabetes, as measured by change in HbA1c level from baseline to 12-week follow-up in both intervention group and control group.
THe secondary endpoint are 1) 1)Difference in TIR (time in range, time in target glucose range, 3.9-10.0mmol/L) at 12 weeks in both groups. 2)Fasting plasma glucose (FPG), lipids and other metabolic related components and parameters such as BMI will be measured. 3)Using questionnaires to evaluate the patients' satisfaction with Flash Glucose Monitoring System.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Weiqing Wang, MD,PHD
- Phone Number: 671701 8621-64370045
- Email: wqingw61@163.com
Study Contact Backup
- Name: Yifei Zhang, MD
- Phone Number: 665344 +86-21-64370045
- Email: feifei-a@163.com
Study Locations
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-
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Shanghai, China
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Type 2 diabetes defined as WHO(1999) diagnostic criteria;
- HbA1c ≥ 7% and ≤ 9% at screening; and fasting plasma glucose ≥ 7.0mmol/L, and <13.3mmol/L;
- Duration: 3 months~15 years;
- BMI: 24~ 28 kg/m2;
- Using 1-3 oral medications when enrolled, and the treatment pattern was stable for at least 3 months and can maintain during this study period;
- Sign the informed consent. Details please see the study protocol.
Exclusion Criteria:
- There are serious diabetic complications, heart, brain, liver and kidney diseases, allergic diseases and organic diseases;
- The subject is currently pregnant, intends to become pregnant or is unwilling or unable to contraception during the study (female only);
- The subject has symptoms or signs of skin lesions, scab, redness, infection or edema at the sensor application site that may affect the accuracy of sensor application or interstitial glucose measurements;
- The subject has a concomitant disease and the investigator believes it will affect the study or pose a risk to the safety or benefit of the subject or research worker.
- An X-ray, MRI, or CT examination is scheduled during the study period, and the appointment could not be changed to before the study started or after the study ended;
- Take aspirin > 200 mg / day, and the drug may be added during the entire study period; Details please see the study protocol.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: therapeutic monitoring
Based on the dietary habits from guidelines, the patients will be instructed to adjust the diet according to the ambulatory glucose profile (AGP) and the recorded log monitored by the continuous glucose monitoring system, thereby implementing"therapeutic monitoring".
|
According to the glucose lever recorded by FreeStyle Libre H (Flash Continuous Glucose Monitoring System) ,the investigators give the intervention group instructions to adjust their diet and lifestyle to abtain a good glucose control.
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No Intervention: The control group
Patients will be given the basic diet, lifestyle instructions according guidelines.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HbA1c
Time Frame: 12 weeks
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Analysis the difference in HbA1c between intervention and control groups at 12 weeks
|
12 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
TIR
Time Frame: 12 weeks
|
time in range, time in target glucose range, 3.9-10.0mmol/L
|
12 weeks
|
Fasting glucose levels
Time Frame: 12 weeks
|
Analysis the difference in Fasting glucose levels between intervention and control groups at 12 weeks
|
12 weeks
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Fasting c-peptide levels
Time Frame: 12 weeks
|
Analysis the difference in Fasting c-peptide levels between intervention and control groups at 12 weeks
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12 weeks
|
Serum Triglycerides
Time Frame: 12 weeks
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Analysis the difference in Serum Triglycerides levels between intervention and control groups at 12 weeks
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12 weeks
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Serum total Cholesterol
Time Frame: 12 weeks
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Analysis the difference in Serum total Cholesterol levels between intervention and control groups at 12 weeks
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12 weeks
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Serum HDL-c
Time Frame: 12 weeks
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Analysis the difference in Serum HDL-c levels between intervention and control groups at 12 weeks
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12 weeks
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Serum LDL-c
Time Frame: 12 weeks
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Analysis the difference in Serum LDL-c levels between intervention and control groups at 12 weeks
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12 weeks
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Body weight
Time Frame: 12 weeks
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weight in kilograms
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12 weeks
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Height
Time Frame: 12 weeks
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height in meters
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12 weeks
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Blood pressure
Time Frame: 12 weeks
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analyses the difference of blood pressure in both groups
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12 weeks
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Creatinine
Time Frame: 12 weeks
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analyses the difference of Creatinine in both groups
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12 weeks
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Uric acid
Time Frame: 12 weeks
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analyses the difference of Uric acid in both groups
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12 weeks
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UCAR
Time Frame: 12 weeks
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Analysis the difference in Urinary albumin creatinine ratio(UCAR) between intervention and control groups at 12 weeks
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12 weeks
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Collaborators and Investigators
Investigators
- Principal Investigator: Weiqing Wang, MD,PHD, Ruijin Hospital
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Ruijin-20191101
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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