- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04847219
Efficacy and Safety of Premixed Insulin Treatment in Patients With Type 2 Diabetes Mellitus
September 22, 2021 updated by: Nanjing First Hospital, Nanjing Medical University
Efficacy and Safety of Premixed Insulin Treatment in Patients With Type 2 Diabetes Mellitus Observed by Different Type of Flash Glucose Mornitoring
The aim of the study is to investigate the efficacy and safety of premixed insulin treatment in patients With type 2 diabetes mellitus using professional and personal Flash Glucose Mornitoring.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Professional and personal Flash Glucose Mornitoring will be used in patients with type 2 diabetes who are treated with premixed insulin.
The frequency of hypogycemia and the blood glucose control will be analyzed by flash glucose mornitoring once a month for 3 months and doctors will adjust the hypoglycemia treatment according to the results every month.
HbA1c, glycemic variation, beta-cell function and androgen levels will be measured.
Study Type
Interventional
Enrollment (Actual)
239
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Jiangsu
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Nanjing, Jiangsu, China, 210012
- Nanjing First Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- participate voluntarily and sign the subject informed consent before the test.
- for patients with type 2 diabetes who met WHO1999 diagnostic criteria, subcutaneous injection with premix insulin Bid/Tid, single drug and/or combination of oral hypoglycemic drugs, the treatment regimen was stable for more than 2 months.
- no acute complications such as diabetic ketoacidosis and diabetic hyperosmolar syndrome.
- subjects are able and willing to undergo FGM examination, diet and exercise regularly.
Exclusion Criteria:
- patients treated with GLP-1 agonist in the last 3 months
- patients who are allergic to insulin.
- impaired liver and renal function, ALT 2.5 times higher than the upper limit of normal value;Serum creatinine was 1.3 times higher than the upper limit of normal.
- a history of drug abuse and alcohol dependence within the past 5 years.
- used systemic hormone therapy in recent 3 months.
- patients with poor compliance and irregular diet and exercise.
- patients with infection and stress within four weeks.
- patients who cannot tolerate flash glucose mornitoring.
- patients who are pregnant, nursing or or preparing to become pregnant.
- any other apparent condition or comorption as determined by the investigator, such as severe heart and lung disease, endocrine disease, neurological disease, tumor disease, other pancreatic disease, history of mental illness.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Professional flash glucose mornitoring
Professional flash glucose mornitoring will be used in patients once a month for 3 months to monitor glucose level.
Patients can learn their blood glucose levels via capillary blood glucose tests, but nor FGM duing FGM, and doctors will adjust their anti-diabetic therapy according to their FGM results after each monitoring.
|
Subjects will use Professional flash glucose mornitoring once a month for 3 months.
|
Active Comparator: Personal flash glucose mornitoring
Personal flash glucose mornitoring will be used in patients once a month for 3 months to monitor glucose level.
Patients can learn their blood glucose levels via FGM duing FGM, and doctors will adjust their anti-diabetic therapy according to their FGM results after each monitoring.
|
Subjects will use Personal flash glucose mornitoring once a month for 3 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
TIme in range
Time Frame: baseline and after 3 month
|
change of TIme in range
|
baseline and after 3 month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
HbA1c
Time Frame: after 3 month
|
change of glycated hemoglobin
|
after 3 month
|
antibody of insulin
Time Frame: baseline and after 3 month
|
antibody of insulin
|
baseline and after 3 month
|
angrogen levels
Time Frame: baseline and after 3 month
|
angrogen levels
|
baseline and after 3 month
|
exercise time daily
Time Frame: baseline and after 3 month
|
duration of exercise daily
|
baseline and after 3 month
|
meal times
Time Frame: baseline and after 3 month
|
daily times of meal
|
baseline and after 3 month
|
calorie intake
Time Frame: baseline and after 3 month
|
daily calorie intake
|
baseline and after 3 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Study Chair: Jianhua Ma, MD, The First Affiliated Hospital with Nanjing Medical University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Yan RN, Cai TT, Jiang LL, Jing T, Cai L, Xie XJ, Su XF, Xu L, He K, Cheng L, Cheng C, Liu BL, Hu Y, Ma JH. Real-Time Flash Glucose Monitoring Had Better Effects on Daily Glycemic Control Compared With Retrospective Flash Glucose Monitoring in Patients With Type 2 Diabetes on Premix Insulin Therapy. Front Endocrinol (Lausanne). 2022 Feb 10;13:832102. doi: 10.3389/fendo.2022.832102. eCollection 2022.
- Cai T, Hu Y, Ding B, Yan R, Liu B, Cai L, Jing T, Jiang L, Xie X, Wang Y, Wang H, Zhou Y, He K, Xu L, Chen L, Cheng C, Ma J. Effect of Metformin on Testosterone Levels in Male Patients With Type 2 Diabetes Mellitus Treated With Insulin. Front Endocrinol (Lausanne). 2021 Dec 24;12:813067. doi: 10.3389/fendo.2021.813067. eCollection 2021.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 9, 2019
Primary Completion (Actual)
April 30, 2021
Study Completion (Actual)
April 30, 2021
Study Registration Dates
First Submitted
December 5, 2019
First Submitted That Met QC Criteria
April 14, 2021
First Posted (Actual)
April 19, 2021
Study Record Updates
Last Update Posted (Actual)
September 27, 2021
Last Update Submitted That Met QC Criteria
September 22, 2021
Last Verified
April 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KY20190926-01
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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