Effect of "Therapeutic Monitoring" on Blood Glucose Control in Type 2 Diabetes

Type2 Diabetes Clinical Trial

Official title:

Evaluate the Effect of "Therapeutic Monitoring"（Flash Continuous Glucose Monitoring System）on Blood Glucose Control in Type 2 Diabetes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04164784
• Other study ID #: Ruijin-20191101
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 10, 2019
• Est. completion date: November 15, 2020

Study information

• Verified date: December 2019
• Source: Shanghai Jiao Tong University School of Medicine
• Contact: Weiqing Wang, MD,PHD
• Phone: 8621-64370045
• Email: wqingw61[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to conduct a multicenter prospective randomized controlled clinical trial, evaluating the effects of "therapeutic monitoring" on blood glucose control in type 2 diabetes.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 480
• Est. completion date: November 15, 2020
• Est. primary completion date: August 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type2 Diabetes

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
China	Ruijin hospital, Shanghai Jiao Tong University School of Medicine	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Jiao Tong University School of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HbA1c	Analysis the difference in HbA1c between intervention and control groups at 12 weeks	12 weeks
Secondary	TIR	time in range, time in target glucose range, 3.9-10.0mmol/L	12 weeks
Secondary	Fasting glucose levels	Analysis the difference in Fasting glucose levels between intervention and control groups at 12 weeks	12 weeks
Secondary	Fasting c-peptide levels	Analysis the difference in Fasting c-peptide levels between intervention and control groups at 12 weeks	12 weeks
Secondary	Serum Triglycerides	Analysis the difference in Serum Triglycerides levels between intervention and control groups at 12 weeks	12 weeks
Secondary	Serum total Cholesterol	Analysis the difference in Serum total Cholesterol levels between intervention and control groups at 12 weeks	12 weeks
Secondary	Serum HDL-c	Analysis the difference in Serum HDL-c levels between intervention and control groups at 12 weeks	12 weeks
Secondary	Serum LDL-c	Analysis the difference in Serum LDL-c levels between intervention and control groups at 12 weeks	12 weeks
Secondary	Body weight	weight in kilograms	12 weeks
Secondary	Height	height in meters	12 weeks
Secondary	Blood pressure	analyses the difference of blood pressure in both groups	12 weeks
Secondary	Creatinine	analyses the difference of Creatinine in both groups	12 weeks
Secondary	Uric acid	analyses the difference of Uric acid in both groups	12 weeks
Secondary	UCAR	Analysis the difference in Urinary albumin creatinine ratio(UCAR) between intervention and control groups at 12 weeks	12 weeks