Type 2 DiabetesNCT04847219
Efficacy and Safety of Premixed Insulin Treatment in Patients With Type 2 Diabetes Mellitus
A study testing Professional flash glucose mornitoring and Personal flash glucose mornitoring in people with Type 2 Diabetes, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 2 Diabetes
- What is being tested?
- Professional flash glucose mornitoring and Personal flash glucose mornitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 239 participants
- Where
- 1 siteChina
- Study dates
- 9 Oct 2019to 30 Apr 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes
- Being tested
- Professional flash glucose mornitoring, Personal flash glucose mornitoring
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Professional flash glucose mornitoringDevice
Subjects will use Professional flash glucose mornitoring once a month for 3 months.
Personal flash glucose mornitoringDevice
Subjects will use Personal flash glucose mornitoring once a month for 3 months.
| Study group | Role | What they receive |
|---|---|---|
| Professional flash glucose mornitoring | Placebo comparator | 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. Receives: Device: Professional flash glucose mornitoring |
| Personal flash glucose mornitoring | Active comparator | 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. Receives: Device: Personal flash glucose mornitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
TIme in range
change of TIme in range
Measured: baseline and after 3 month
Secondary outcomes (6)
HbA1c
change of glycated hemoglobin
Measured: after 3 month
antibody of insulin
antibody of insulin
Measured: baseline and after 3 month
angrogen levels
angrogen levels
Measured: baseline and after 3 month
exercise time daily
duration of exercise daily
Measured: baseline and after 3 month
meal times
daily times of meal
Measured: baseline and after 3 month
calorie intake
daily calorie intake
Measured: baseline and after 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2021
- Study start9 Oct 2019
- Primary completion30 Apr 2021
- Study completion30 Apr 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Type 2 DiabetesStudies of the same condition, open and under way.
- More trials run by Nanjing First Hospital, Nanjing Medical UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Jianhua Ma, MD, Study chair, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04847219
- Sponsor's protocol ID
- KY20190926-01
- Status last verified
- Apr 2021
- First submitted
- 5 Dec 2019
- Last updated
- 27 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kong D, Shen Z, Jiang L, Xie X, Yan R, Jing T, Hu Y, Ma J. The effects of vildagliptin on glycemic variability in patients with type 2 diabetes on premixed insulin therapy. Front Endocrinol (Lausanne). 2025 Jun 20;16:1508918. doi: 10.3389/fendo.2025.1508918. eCollection 2025.
PubMed 40620795Yan 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.
PubMed 35222287Cai 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.
PubMed 35002984
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Premixed Insulin Treatment in Patients With Type 2 Diabetes Mellitus Observed by Different Type of Flash Glucose Mornitoring
- ClinicalTrials.gov ID
- NCT04847219
- Acronym / sponsor ID
- KY20190926-01
- Conditions
- Type 2 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- 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
- Study start
- 9 Oct 2019 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 19 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Professional flash glucose mornitoring | Placebo comparator | Device: Professional flash glucose mornitoringProfessional 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. |
| Personal flash glucose mornitoring | Active comparator | Device: Personal flash glucose mornitoringPersonal 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Professional flash glucose mornitoringSubjects will use Professional flash glucose mornitoring once a month for 3 months. | Device | Professional flash glucose mornitoring |
| Personal flash glucose mornitoringSubjects will use Personal flash glucose mornitoring once a month for 3 months. | Device | Personal flash glucose mornitoring |
Primary outcome
TIme in range
Time frame: baseline and after 3 month
change of TIme in range
6 secondary outcomes
HbA1c
Time frame: after 3 month
antibody of insulin
Time frame: baseline and after 3 month
angrogen levels
Time frame: baseline and after 3 month
exercise time daily
Time frame: baseline and after 3 month
meal times
Time frame: baseline and after 3 month
calorie intake
Time frame: baseline and after 3 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Sep 2021.
- Derived from this study: PubMed 40620795Kong D, Shen Z, Jiang L, Xie X, Yan R, Jing T, Hu Y, Ma J. The effects of vildagliptin on glycemic variability in patients with type 2 diabetes on premixed insulin therapy. Front Endocrinol (Lausanne). 2025 Jun 20;16:1508918. doi: 10.3389/fendo.2025.1508918. eCollection 2025.
- Derived from this study: PubMed 35222287Yan 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.
- Derived from this study: PubMed 35002984Cai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jianhua Ma, MD study chair
The First Affiliated Hospital with Nanjing Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Professional flash glucose mornitoring and Personal flash glucose mornitoring in people with Type 2 Diabetes, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
TIme in range (time frame: baseline and after 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04847219, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Sep 2021.