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

Primary Purpose

Type2 Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
therapeutic monitoring
Sponsored by
Shanghai Jiao Tong University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type2 Diabetes

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Ruijin hospital, Shanghai Jiao Tong University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

therapeutic monitoring

The control group

Arm Description

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".

Patients will be given the basic diet, lifestyle instructions according guidelines.

Outcomes

Primary Outcome Measures

HbA1c
Analysis the difference in HbA1c between intervention and control groups at 12 weeks

Secondary Outcome Measures

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

Full Information

First Posted
November 13, 2019
Last Updated
December 10, 2019
Sponsor
Shanghai Jiao Tong University School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04164784
Brief Title
Effect of "Therapeutic Monitoring" on Blood Glucose Control in Type 2 Diabetes
Official Title
Evaluate the Effect of "Therapeutic Monitoring"（Flash Continuous Glucose Monitoring System）on Blood Glucose Control in Type 2 Diabetes
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
December 10, 2019 (Anticipated)
Primary Completion Date
August 15, 2020 (Anticipated)
Study Completion Date
November 15, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai Jiao Tong University School of Medicine

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 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type2 Diabetes

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
therapeutic monitoring
Arm Type
Experimental
Arm Description
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".
Arm Title
The control group
Arm Type
No Intervention
Arm Description
Patients will be given the basic diet, lifestyle instructions according guidelines.
Intervention Type
Behavioral
Intervention Name(s)
therapeutic monitoring
Intervention Description
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.
Primary Outcome Measure Information:
Title
HbA1c
Description
Analysis the difference in HbA1c between intervention and control groups at 12 weeks
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
TIR
Description
time in range, time in target glucose range, 3.9-10.0mmol/L
Time Frame
12 weeks
Title
Fasting glucose levels
Description
Analysis the difference in Fasting glucose levels between intervention and control groups at 12 weeks
Time Frame
12 weeks
Title
Fasting c-peptide levels
Description
Analysis the difference in Fasting c-peptide levels between intervention and control groups at 12 weeks
Time Frame
12 weeks
Title
Serum Triglycerides
Description
Analysis the difference in Serum Triglycerides levels between intervention and control groups at 12 weeks
Time Frame
12 weeks
Title
Serum total Cholesterol
Description
Analysis the difference in Serum total Cholesterol levels between intervention and control groups at 12 weeks
Time Frame
12 weeks
Title
Serum HDL-c
Description
Analysis the difference in Serum HDL-c levels between intervention and control groups at 12 weeks
Time Frame
12 weeks
Title
Serum LDL-c
Description
Analysis the difference in Serum LDL-c levels between intervention and control groups at 12 weeks
Time Frame
12 weeks
Title
Body weight
Description
weight in kilograms
Time Frame
12 weeks
Title
Height
Description
height in meters
Time Frame
12 weeks
Title
Blood pressure
Description
analyses the difference of blood pressure in both groups
Time Frame
12 weeks
Title
Creatinine
Description
analyses the difference of Creatinine in both groups
Time Frame
12 weeks
Title
Uric acid
Description
analyses the difference of Uric acid in both groups
Time Frame
12 weeks
Title
UCAR
Description
Analysis the difference in Urinary albumin creatinine ratio（UCAR） between intervention and control groups at 12 weeks
Time Frame
12 weeks

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: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weiqing Wang, MD,PHD
Phone
8621-64370045
Ext
671701
Email
wqingw61@163.com
First Name & Middle Initial & Last Name or Official Title & Degree
Yifei Zhang, MD
Phone
+86-21-64370045
Ext
665344
Email
feifei-a@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weiqing Wang, MD,PHD
Organizational Affiliation
Ruijin Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ruijin hospital, Shanghai Jiao Tong University School of Medicine
City
Shanghai
Country
China

12. IPD Sharing Statement

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

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