Efficacy and Safety of Premixed Insulin Treatment in Patients With Type 2 Diabetes Mellitus
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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 Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- TIme in range [baseline and after 3 month]
change of TIme in range
Secondary Outcome Measures
- HbA1c [after 3 month]
change of glycated hemoglobin
- antibody of insulin [baseline and after 3 month]
antibody of insulin
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
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participate voluntarily and sign the subject informed consent before the test.
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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.
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no acute complications such as diabetic ketoacidosis and diabetic hyperosmolar syndrome.
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subjects are able and willing to undergo FGM examination, diet and exercise regularly.
Exclusion Criteria:
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patients treated with GLP-1 agonist in the last 3 months
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patients who are allergic to insulin.
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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.
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a history of drug abuse and alcohol dependence within the past 5 years.
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used systemic hormone therapy in recent 3 months.
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patients with poor compliance and irregular diet and exercise.
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patients with infection and stress within four weeks.
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patients who cannot tolerate flash glucose mornitoring.
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patients who are pregnant, nursing or or preparing to become pregnant.
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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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Nanjing First Hospital | Nanjing | Jiangsu | China | 210012 |
Sponsors and Collaborators
- Nanjing First Hospital, Nanjing Medical University
- 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
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- KY20190926-01