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

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ClinicalTrials.gov Identifier: NCT04164784
Recruitment Status : Not yet recruiting
First Posted : November 15, 2019
Last Update Posted : November 15, 2019
Sponsor:
Information provided by (Responsible Party):
Wang Weiqing, Shanghai Jiao Tong University School of Medicine

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.

Condition or disease Intervention/treatment Phase
Type2 Diabetes Behavioral: therapeutic monitoring Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 480 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluate the Effect of "Therapeutic Monitoring"(Flash Continuous Glucose Monitoring System)on Blood Glucose Control in Type 2 Diabetes
Estimated Study Start Date : November 20, 2019
Estimated Primary Completion Date : August 15, 2020
Estimated Study Completion Date : November 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar

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) ,we 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.



Primary Outcome Measures :
  1. HbA1c [ Time Frame: 12 weeks ]
    Analysis the difference in HbA1c between intervention and control groups at 12 weeks


Secondary Outcome Measures :
  1. TIR [ Time Frame: 12 weeks ]
    time in range, time in target glucose range, 3.9-10.0mmol/L

  2. Fasting glucose levels [ Time Frame: 12 weeks ]
    Analysis the difference in Fasting glucose levels between intervention and control groups at 12 weeks

  3. Fasting c-peptide levels [ Time Frame: 12 weeks ]
    Analysis the difference in Fasting c-peptide levels between intervention and control groups at 12 weeks

  4. Serum Triglycerides [ Time Frame: 12 weeks ]
    Analysis the difference in Serum Triglycerides levels between intervention and control groups at 12 weeks

  5. Serum total Cholesterol [ Time Frame: 12 weeks ]
    Analysis the difference in Serum total Cholesterol levels between intervention and control groups at 12 weeks

  6. Serum HDL-c [ Time Frame: 12 weeks ]
    Analysis the difference in Serum HDL-c levels between intervention and control groups at 12 weeks

  7. Serum LDL-c [ Time Frame: 12 weeks ]
    Analysis the difference in Serum LDL-c levels between intervention and control groups at 12 weeks

  8. BMI [ Time Frame: 12 weeks ]
    Body mass index (BMI)

  9. Blood pressure [ Time Frame: 12 weeks ]
    analyses the difference of blood pressure in both groups

  10. Creatinine [ Time Frame: 12 weeks ]
    analyses the difference of Creatinine in both groups

  11. Uric acid [ Time Frame: 12 weeks ]
    analyses the difference of Uric acid in both groups

  12. UCAR [ Time Frame: 12 weeks ]
    Analysis the difference in Urinary albumin creatinine ratio(UCAR) between intervention and control groups at 12 weeks



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Type 2 diabetes defined as WHO(1999) diagnostic criteria;
  2. HbA1c ≥ 7% and ≤ 9% at screening; and fasting plasma glucose ≥ 7.0mmol/L, and <13.3mmol/L;

4.Duration: 3 months~15 years; 5.BMI: 24~ 28 kg/m2; 6.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; 7.Sign the informed consent. Details please see the study protocol.

Exclusion Criteria:

  1. There are serious diabetic complications, heart, brain, liver and kidney diseases, allergic diseases and organic diseases;
  2. The subject is currently pregnant, intends to become pregnant or is unwilling or unable to contraception during the study (female only);
  3. 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;
  4. 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.
  5. 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;
  6. Take aspirin > 200 mg / day, and the drug may be added during the entire study period; Details please see the study protocol.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04164784


Contacts
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Contact: Weiqing Wang, MD,PHD 8621-64370045 ext 671701 wqingw61@163.com
Contact: Yifei Zhang, MD +86-21-64370045 ext 665344 feifei-a@163.com

Locations
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China
Ruijin hospital, Shanghai Jiao Tong University School of Medicine
Shanghai, China
Sponsors and Collaborators
Shanghai Jiao Tong University School of Medicine
Investigators
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Principal Investigator: Weiqing Wang, MD,PHD Ruijin Hospital

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Responsible Party: Wang Weiqing, Professor, Shanghai Jiao Tong University School of Medicine
ClinicalTrials.gov Identifier: NCT04164784     History of Changes
Other Study ID Numbers: Ruijin-20191101
First Posted: November 15, 2019    Key Record Dates
Last Update Posted: November 15, 2019
Last Verified: November 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases