Back to resultsEfficacy and Safety of Premixed Insulin Treatment in Patients With Type 2 Diabetes Mellitus
Primary Purpose
Type 2 Diabetes
Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Professional flash glucose mornitoring
Personal flash glucose mornitoring
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes
Eligibility Criteria
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.
Sites / Locations
- Nanjing First Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Professional flash glucose mornitoring
Personal flash glucose mornitoring
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
TIme in range
change of TIme in range
Secondary Outcome Measures
HbA1c
change of glycated hemoglobin
antibody of insulin
antibody of insulin
angrogen levels
angrogen levels
exercise time daily
duration of exercise daily
meal times
daily times of meal
calorie intake
daily calorie intake
Full Information
NCT ID
NCT04847219
First Posted
December 5, 2019
Last Updated
September 22, 2021
Sponsor
Nanjing First Hospital, Nanjing Medical University
Collaborators
Wuxi Hospital of Traditional Chinese Medicine, Wuxi People's Hospital Affiliated to Nanjing Medical University, Huai'an Second People's Hospital and the Affiliated Huai'an Hospital of Xuzhou Medical University, The Affiliated Suqian First People's Hospital of Nanjing Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04847219
Brief Title
Efficacy and Safety of Premixed Insulin Treatment in Patients With Type 2 Diabetes Mellitus
Official Title
Efficacy and Safety of Premixed Insulin Treatment in Patients With Type 2 Diabetes Mellitus Observed by Different Type of Flash Glucose Mornitoring
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 9, 2019 (Actual)
Primary Completion Date
April 30, 2021 (Actual)
Study Completion Date
April 30, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Nanjing First Hospital, Nanjing Medical University
Collaborators
Wuxi Hospital of Traditional Chinese Medicine, Wuxi People's Hospital Affiliated to Nanjing Medical University, Huai'an Second People's Hospital and the Affiliated Huai'an Hospital of Xuzhou Medical University, The Affiliated Suqian First People's Hospital of Nanjing Medical University
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 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
239 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Professional flash glucose mornitoring
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
Personal flash glucose mornitoring
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Professional flash glucose mornitoring
Intervention Description
Subjects will use Professional flash glucose mornitoring once a month for 3 months.
Intervention Type
Device
Intervention Name(s)
Personal flash glucose mornitoring
Intervention Description
Subjects will use Personal flash glucose mornitoring once a month for 3 months.
Primary Outcome Measure Information:
Title
TIme in range
Description
change of TIme in range
Time Frame
baseline and after 3 month
Secondary Outcome Measure Information:
Title
HbA1c
Description
change of glycated hemoglobin
Time Frame
after 3 month
Title
antibody of insulin
Description
antibody of insulin
Time Frame
baseline and after 3 month
Title
angrogen levels
Description
angrogen levels
Time Frame
baseline and after 3 month
Title
exercise time daily
Description
duration of exercise daily
Time Frame
baseline and after 3 month
Title
meal times
Description
daily times of meal
Time Frame
baseline and after 3 month
Title
calorie intake
Description
daily calorie intake
Time Frame
baseline and after 3 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jianhua Ma, MD
Organizational Affiliation
The First Affiliated Hospital with Nanjing Medical University
Official's Role
Study Chair
Facility Information:
Facility Name
Nanjing First Hospital
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210012
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
35222287
Citation
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.
Results Reference
derived
PubMed Identifier
35002984
Citation
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.
Results Reference
derived
Learn more about this trial
Efficacy and Safety of Premixed Insulin Treatment in Patients With Type 2 Diabetes Mellitus
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