NCT04164784

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
480

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2019

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 13, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 15, 2019

Completed
25 days until next milestone

Study Start

First participant enrolled

December 10, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 15, 2020

Completed
Last Updated

December 13, 2019

Status Verified

December 1, 2019

Enrollment Period

8 months

First QC Date

November 13, 2019

Last Update Submit

December 10, 2019

Conditions

Type2 Diabetes

Outcome Measures

Primary Outcomes (1)

  • HbA1c

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

    12 weeks

Secondary Outcomes (13)

  • TIR

    12 weeks

  • Fasting glucose levels

    12 weeks

  • Fasting c-peptide levels

    12 weeks

  • Serum Triglycerides

    12 weeks

  • Serum total Cholesterol

    12 weeks

  • +8 more secondary outcomes

Study Arms (2)

therapeutic monitoring

EXPERIMENTAL

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

The control group

NO INTERVENTION

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

Interventions

therapeutic monitoringBEHAVIORAL

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.

therapeutic monitoring

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ruijin hospital, Shanghai Jiao Tong University School of Medicine

Shanghai, China

Location

Study Officials

  • Weiqing Wang, MD,PHD

    Ruijin Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Weiqing Wang, MD,PHD

CONTACT

8621-64370045wqingw61@163.com

Yifei Zhang, MD

CONTACT

+86-21-64370045feifei-a@163.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

November 13, 2019

First Posted

November 15, 2019

Study Start

December 10, 2019

Primary Completion

August 15, 2020

Study Completion

November 15, 2020

Last Updated

December 13, 2019

Record last verified: 2019-12

Locations

CN(1)