Type2 DiabetesNCT04164784
Effect of "Therapeutic Monitoring" on Blood Glucose Control in Type 2 Diabetes
A study testing therapeutic monitoring in people with Type2 Diabetes, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type2 Diabetes
- What is being tested?
- therapeutic monitoring
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteChina
- Study dates
- 10 Dec 2019to 15 Nov 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Ruijin hospital, Shanghai Jiao Tong University School of Medicine
Shanghai
About this study
Official title: 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.
Read the 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.
- Conditions
- Type2 Diabetes
- Being tested
- therapeutic monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
therapeutic monitoringBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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". Receives: Behavioral: therapeutic monitoring |
| The control group | No intervention | Patients will be given the basic diet, lifestyle instructions according guidelines. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Analysis the difference in HbA1c between intervention and control groups at 12 weeks
Measured: 12 weeks
Secondary outcomes (13)
TIR
time in range, time in target glucose range, 3.9-10.0mmol/L
Measured: 12 weeks
Fasting glucose levels
Analysis the difference in Fasting glucose levels between intervention and control groups at 12 weeks
Measured: 12 weeks
Fasting c-peptide levels
Analysis the difference in Fasting c-peptide levels between intervention and control groups at 12 weeks
Measured: 12 weeks
Serum Triglycerides
Analysis the difference in Serum Triglycerides levels between intervention and control groups at 12 weeks
Measured: 12 weeks
Serum total Cholesterol
Analysis the difference in Serum total Cholesterol levels between intervention and control groups at 12 weeks
Measured: 12 weeks
Serum HDL-c
Analysis the difference in Serum HDL-c levels between intervention and control groups at 12 weeks
Measured: 12 weeks
Serum LDL-c
Analysis the difference in Serum LDL-c levels between intervention and control groups at 12 weeks
Measured: 12 weeks
Body weight
weight in kilograms
Measured: 12 weeks
Height
height in meters
Measured: 12 weeks
Blood pressure
analyses the difference of blood pressure in both groups
Measured: 12 weeks
Creatinine
analyses the difference of Creatinine in both groups
Measured: 12 weeks
Uric acid
analyses the difference of Uric acid in both groups
Measured: 12 weeks
UCAR
Analysis the difference in Urinary albumin creatinine ratio（UCAR） between intervention and control groups at 12 weeks
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2019
- Study start10 Dec 2019 (estimated)
- Primary completion15 Aug 2020 (estimated)
- Study completion15 Nov 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type2 DiabetesStudies of the same condition, open and under way.
- More trials run by Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wang Weiqing, Shanghai Jiao Tong University School of Medicine
- Investigators
- Weiqing Wang, MD,PHD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04164784
- Sponsor's protocol ID
- Ruijin-20191101
- Status last verified
- Dec 2019
- First submitted
- 13 Nov 2019
- Last updated
- 13 Dec 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluate the Effect of "Therapeutic Monitoring"（Flash Continuous Glucose Monitoring System）on Blood Glucose Control in Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT04164784
- Acronym / sponsor ID
- Ruijin-20191101
- Conditions
- Type2 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 10 Dec 2019 (estimated)
- Primary completion
- 15 Aug 2020 (estimated)
- Study completion
- 15 Nov 2020 (estimated)
- First posted
- 15 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| therapeutic monitoring | Experimental | Behavioral: therapeutic monitoringBased 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". |
| The control group | No intervention | –Patients will be given the basic diet, lifestyle instructions according guidelines. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (6 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| therapeutic monitoringAccording 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. | Behavioural | therapeutic monitoring |
Primary outcome
HbA1c
Time frame: 12 weeks
Analysis the difference in HbA1c between intervention and control groups at 12 weeks
13 secondary outcomes
TIR
Time frame: 12 weeks
Fasting glucose levels
Time frame: 12 weeks
Fasting c-peptide levels
Time frame: 12 weeks
Serum Triglycerides
Time frame: 12 weeks
Serum total Cholesterol
Time frame: 12 weeks
Serum HDL-c
Time frame: 12 weeks
Serum LDL-c
Time frame: 12 weeks
Body weight
Time frame: 12 weeks
Height
Time frame: 12 weeks
Blood pressure
Time frame: 12 weeks
Creatinine
Time frame: 12 weeks
Uric acid
Time frame: 12 weeks
UCAR
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Dec 2019.
Related trials for Type2 Diabetes
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruitingPhase 3
A Study to Evaluate the Effectiveness and Safety of the Drug AZD6234 for Managing Weight in Adults Who Are Obese or Overweight. These Participants May or May Not Also Have Type 2 Diabetes
Obesity, Overweight
Not yet recruiting
Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)
Type 2 Diabetes Mellitus (T2D), Obesity (BMI>30)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Weiqing Wang, MD,PHD principal investigator
Ruijin Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing therapeutic monitoring in people with Type2 Diabetes, run by Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Weiqing Wang, MD,PHD (8621-64370045 ext. 671701, wqingw61@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Dec 2019.