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

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.

Study Overview

• Status: Unknown
• Conditions: Type2 Diabetes
• Intervention / Treatment: Behavioral: therapeutic monitoring

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: Interventional
• Enrollment (Anticipated): 480
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai, China
    • Ruijin Hospital, Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

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)

Number of Arms

2

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".	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.
No Intervention: The control group; Patients will be given the basic diet, lifestyle instructions according guidelines.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	Analysis the difference in HbA1c between intervention and control groups at 12 weeks	12 weeks

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Shanghai Jiao Tong University School of Medicine
• Investigators: Principal Investigator: Weiqing Wang, MD,PHD, Ruijin Hospital

Study record dates

Study Major Dates

• Study Start (Anticipated): December 10, 2019
• Primary Completion (Anticipated): August 15, 2020
• Study Completion (Anticipated): November 15, 2020

Study Registration Dates

• First Submitted: November 13, 2019
• First Submitted That Met QC Criteria: November 13, 2019
• First Posted (Actual): November 15, 2019

Study Record Updates

• Last Update Posted (Actual): December 13, 2019
• Last Update Submitted That Met QC Criteria: December 10, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• Other Study ID Numbers: Ruijin-20191101

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No