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Completed

NCT Number: NCT04847219

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Nanjing First Hospital

Nanjing, Jiangsu, 210012, China

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Professional flash glucose mornitoring

Device

Subjects will use Professional flash glucose mornitoring once a month for 3 months.

Personal flash glucose mornitoring

Device

Subjects will use Personal flash glucose mornitoring once a month for 3 months.

Primary outcomes

  1. TIme in range

    Time frame: baseline and after 3 month

    change of TIme in range

Secondary outcomes

  1. HbA1c

    Time frame: after 3 month

    change of glycated hemoglobin

  2. antibody of insulin

    Time frame: baseline and after 3 month

    antibody of insulin

  3. angrogen levels

    Time frame: baseline and after 3 month

    angrogen levels

  4. exercise time daily

    Time frame: baseline and after 3 month

    duration of exercise daily

  5. meal times

    Time frame: baseline and after 3 month

    daily times of meal

  6. calorie intake

    Time frame: baseline and after 3 month

    daily calorie intake

Sponsors and collaborators

Lead sponsor

Nanjing First Hospital, Nanjing Medical University

Other

Collaborators

  • 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
  • Wuxi Hospital of Traditional Chinese Medicine
  • Wuxi People's Hospital Affiliated to Nanjing Medical University

Registry information

Official study title

Efficacy and Safety of Premixed Insulin Treatment in Patients With Type 2 Diabetes Mellitus Observed by Different Type of Flash Glucose Mornitoring

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Apr 19, 2021
Registry last updated
Sep 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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