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

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: Type 2 Diabetes
• Intervention / Treatment: Device: Professional flash glucose mornitoring; Device: 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 Type: Interventional
• Enrollment (Actual): 239
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Jiangsu
    • Nanjing, Jiangsu, China, 210012
      • Nanjing First Hospital

Participation Criteria

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:

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

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.	Device: Professional flash glucose mornitoring; 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.	Device: Personal flash glucose mornitoring; 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	change of TIme in range	baseline and after 3 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
HbA1c	change of glycated hemoglobin	after 3 month
antibody of insulin	antibody of insulin	baseline and after 3 month
angrogen levels	angrogen levels	baseline and after 3 month
exercise time daily	duration of exercise daily	baseline and after 3 month
meal times	daily times of meal	baseline and after 3 month
calorie intake	daily calorie intake	baseline and after 3 month

Collaborators and Investigators

• 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
• Investigators: Study Chair: Jianhua Ma, MD, The First Affiliated Hospital with Nanjing Medical University

Publications and helpful links

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

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: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2
• 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