Clinical trial NCT04847219: 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
Overall status: COMPLETED
Phase: NA
Conditions: Type 2 Diabetes
Lead sponsor: Nanjing First Hospital, Nanjing Medical University
Sponsor class: OTHER
Collaborators: name: Wuxi Hospital of Traditional Chinese Medicine
name: Wuxi People's Hospital Affiliated to Nanjing Medical University
name: Huai'an Second People's Hospital and the Affiliated Huai'an Hospital of Xuzhou Medical University
name: The Affiliated Suqian First People's Hospital of Nanjing Medical University
First posted: 2021-04-19
Enrollment: 239
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. participate voluntarily and sign the subject informed consent before the test.
2. 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.
3. no acute complications such as diabetic ketoacidosis and diabetic hyperosmolar syndrome.
4. subjects are able and willing to undergo FGM examination, diet and exercise regularly.

Exclusion Criteria:

1. patients treated with GLP-1 agonist in the last 3 months
2. patients who are allergic to insulin.
3. 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.
4. a history of drug abuse and alcohol dependence within the past 5 years.
5. used systemic hormone therapy in recent 3 months.
6. patients with poor compliance and irregular diet and exercise.
7. patients with infection and stress within four weeks.
8. patients who cannot tolerate flash glucose mornitoring.
9. patients who are pregnant, nursing or or preparing to become pregnant.
10. 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.

Primary outcomes:
measure: TIme in range
timeFrame: baseline and after 3 month
Secondary outcomes:
measure: HbA1c
timeFrame: after 3 month
measure: antibody of insulin
timeFrame: baseline and after 3 month
measure: angrogen levels
timeFrame: baseline and after 3 month
measure: exercise time daily
timeFrame: baseline and after 3 month
measure: meal times
timeFrame: baseline and after 3 month
measure: calorie intake
timeFrame: baseline and after 3 month
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Nanjing First Hospital
state: Jiangsu
Study officials:
affiliation: The First Affiliated Hospital with Nanjing Medical University
name: Jianhua Ma, MD
role: STUDY_CHAIR
References:
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.
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.