Efficacy and Safety of Premixed Insulin Treatment in Patients With Type 2 Diabetes Mellitus

Not Applicable

Completed

• Conditions: Type 2 Diabetes
• Interventions: Device: Personal flash glucose mornitoring; Device: Professional flash glucose mornitoring

• Registration Number: NCT04847219
• Lead Sponsor: Nanjing First Hospital, Nanjing Medical University

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.

Study Timeline

• Study Start: 2019-10-09
• Study First Submitted: 2019-12-05
• Status Verified: 2021-04
• Study First Submitted QC: 2021-04-14
• Study First Posted: 2021-04-19
• Primary Completion: 2021-04-30
• Study Completion: 2021-04-30
• Last Update Submitted: 2021-09-22
• Last Update Posted: 2021-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 239

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Personal flash glucose mornitoring	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.
Professional flash glucose mornitoring	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.

Primary Outcome Measures

Name	Time	Method
TIme in range	baseline and after 3 month	change of TIme in range

Secondary Outcome Measures

Name	Time	Method
antibody of insulin	baseline and after 3 month	antibody of insulin
HbA1c	after 3 month	change of glycated hemoglobin
angrogen levels	baseline and after 3 month	angrogen levels
exercise time daily	baseline and after 3 month	duration of exercise daily
meal times	baseline and after 3 month	daily times of meal
calorie intake	baseline and after 3 month	daily calorie intake

Trial Locations

Locations (1)

Nanjing First Hospital; 🇨🇳 Nanjing, Jiangsu, China