Effect of "Therapeutic Monitoring" on Blood Glucose Control in Type 2 Diabetes
NCT ID: NCT04164784
Last Updated: 2019-12-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
480 participants
INTERVENTIONAL
2019-12-10
2020-11-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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".
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.
The control group
Patients will be given the basic diet, lifestyle instructions according guidelines.
No interventions assigned to this group
Interventions
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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.
Eligibility Criteria
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Inclusion 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
* 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.
18 Years
70 Years
ALL
No
Sponsors
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Shanghai Jiao Tong University School of Medicine
OTHER
Responsible Party
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Wang Weiqing
Professor
Principal Investigators
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Weiqing Wang, MD,PHD
Role: PRINCIPAL_INVESTIGATOR
Ruijin Hospital
Locations
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Ruijin hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, , China
Countries
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Central Contacts
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Other Identifiers
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Ruijin-20191101
Identifier Type: -
Identifier Source: org_study_id