Diabetes MellitusNCT03785301
Effect of FGM on Glucose Control in Diabetic Patients
A study testing Freestyle Libre Flash Glucose Monitoring in people with Diabetes Mellitus, run by Nanjing First Hospital, Nanjing Medical University at 1 site in China.
Trial summary
The aim of the study is to assess the effect of FGM on glycemic control compared with SMBG using a randomised controlled study design in adults with type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus
- What is being tested?
- Freestyle Libre Flash Glucose Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 1 siteChina
- Study dates
- 20 Dec 2018to 31 Dec 2019
- 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
- >18 years old;
- diagnosed as having diabetes who were willing to perform the study and complete the data collection;
- in stable condition prior to the study.
Who cannot join
- pregnancy or attempting to conceive;
- known allergy to medical grade adhesive or isopropyl alcohol used to prepare the skin;
- skin lesions, scarring, redness, infection, or edema at the sensor application sites;
- patients whose conditions were extremely severe and not stable.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nanjing First Hostital
Nanjing, Jiangsu, 210000
Jianhua Ma, Doctor, +8618951670116, majianhua196503@126.com
About this study
The aim of the study is to assess the effect of FGM on glycemic control compared with SMBG using a randomised controlled study design in adults with type 2 diabetes.
Read the detailed description
Flash glucose monitoring (FGM) is a newly introduced Glucose Monitoring system. The aim of the study is to assess the effect of FGM on glycemic control compared with standard blood glucose monitoring (SMBG) using a randomised controlled study design in adults with type 2 diabetes. Subjects will use unmasked FGM once a month or SMBG to monitor glucose level for 3 months. Patients in the SMBG group will wear masked FGM to collect glycaemic variability data for comparison to the intervention group of the study. The primary outcome, HbA1c, will be cpmpared at baseline and 3 month. Glucose control parameters provided by unmasked and masked FGM will be compared in the two groups, including mean blood glucose (MBG), coefficient of variation (CV), area under the curve (AUC), Time in Range(TIR), etc.
- Conditions
- Diabetes Mellitus
- Being tested
- Freestyle Libre Flash Glucose Monitoring
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Freestyle Libre Flash Glucose MonitoringDevice
Freestyle Libre Flash Glucose Monitoring will be used in diabetic patients once a month for therr months to monitor glucose level. Patients could scan the sensor to get the glucose level at any time as they want. They could alter thier diet and exercise according to the glucose levels. Patients will be required to keep track of food and exercise during wearing FGM sensor. Physicians would adjust patients' medication according their glucose profile provided by FGM, A1c, and diet and exercise every month.
| Study group | Role | What they receive |
|---|---|---|
| FGM group | Experimental | Diabetic patients will use FreeStyle Libre Flash Glucose Monitoring (FGM) system(unmasked) to monitor glucose level once a month for 3 months. Receives: Device: Freestyle Libre Flash Glucose Monitoring |
| SMBG group | No intervention | Diabetic patients will use Standard Blood Glucose Monitoring (SMBG) to monitor glucose level for 3 months. A 14-day masked wear of FreeStyle Libre H Flash Glucose Monitoring system is included for these subjects once a month, to collect glycaemic variability data for comparison to the intervention group of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c
Difference in HbA1c between intervention and control group at 3 month adjusting for baseline HbA1c
Measured: 3 months
Secondary outcomes (5)
mean blood glucose (MBG)
Difference in HbA1c between intervention and control group at 1, 2, and 3 month.
Measured: 1,2,3 months
coefficient of variation (CV)
Difference in CV between intervention and control group at 1, 2, and 3 month.
Measured: 1,2,3 months
area under the curve (AUC)<3.9mmol/L and >10mmol/L
Difference in AUC<3.9mmol/L and >10mmol/L between intervention and control group at 1, 2, and 3 month.
Measured: 1,2,3 months
Time in Range (TIR)
Difference in time in range 3.9-10 mmol/L between intervention and control group at 1, 2, and 3 month.
Measured: 1,2,3 months
FGM accuracy
Accuracy of FGM values versus reference blood glucose values (Consensus Error Grid (CEG) analysis and calculation of the Mean Absolute Relative Difference (MARD)
Measured: during FGM
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2018
- Study start20 Dec 2018
- Primary completion31 Oct 2019 (estimated)
- Study completion31 Dec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes MellitusStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ma Jianhua, MD, Study chair, The First Affiliated Hospital with Nanjing Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03785301
- Sponsor's protocol ID
- KY20170904-04
- Status last verified
- Aug 2018
- First submitted
- 20 Dec 2018
- Last updated
- 11 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen M, Li H, Shen Y, Liu B, Yan R, Sun X, Ye L, Lee KO, Ma J, Su X. Flash Glucose Monitoring Improves Glucose Control in People with Type 2 Diabetes Mellitus Receiving Anti-diabetic Drug Medication. Exp Clin Endocrinol Diabetes. 2021 Dec;129(12):857-863. doi: 10.1055/a-0994-9850. Epub 2020 Aug 28.
PubMed 32858752Hu Y, Shen Y, Yan R, Li F, Ding B, Wang H, Su X, Ma J. Relationship Between Estimated Glycosylated Hemoglobin Using Flash Glucose Monitoring and Actual Measured Glycosylated Hemoglobin in a Chinese Population. Diabetes Ther. 2020 Sep;11(9):2019-2027. doi: 10.1007/s13300-020-00879-x. Epub 2020 Jul 21.
PubMed 32696267
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of FGM on Glucose Control in Diabetic Patients
- ClinicalTrials.gov ID
- NCT03785301
- Acronym / sponsor ID
- KY20170904-04
- Conditions
- Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Nanjing First Hospital, Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 20 Dec 2018 (actual)
- Primary completion
- 31 Oct 2019 (estimated)
- Study completion
- 31 Dec 2019 (estimated)
- First posted
- 24 Dec 2018 (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 assess the effect of FGM on glycemic control compared with SMBG using a randomised controlled study design in adults with type 2 diabetes.
Detailed description
Flash glucose monitoring (FGM) is a newly introduced Glucose Monitoring system. The aim of the study is to assess the effect of FGM on glycemic control compared with standard blood glucose monitoring (SMBG) using a randomised controlled study design in adults with type 2 diabetes. Subjects will use unmasked FGM once a month or SMBG to monitor glucose level for 3 months. Patients in the SMBG group will wear masked FGM to collect glycaemic variability data for comparison to the intervention group of the study. The primary outcome, HbA1c, will be cpmpared at baseline and 3 month. Glucose control parameters provided by unmasked and masked FGM will be compared in the two groups, including mean blood glucose (MBG), coefficient of variation (CV), area under the curve (AUC), Time in Range(TIR), etc.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FGM group | Experimental | Device: Freestyle Libre Flash Glucose MonitoringDiabetic patients will use FreeStyle Libre Flash Glucose Monitoring (FGM) system(unmasked) to monitor glucose level once a month for 3 months. |
| SMBG group | No intervention | –Diabetic patients will use Standard Blood Glucose Monitoring (SMBG) to monitor glucose level for 3 months. A 14-day masked wear of FreeStyle Libre H Flash Glucose Monitoring system is included for these subjects once a month, to collect glycaemic variability data for comparison to the intervention group of the study. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- >18 years old;
- diagnosed as having diabetes who were willing to perform the study and complete the data collection;
- in stable condition prior to the study.
Key exclusion criteria (4 listed)
- pregnancy or attempting to conceive;
- known allergy to medical grade adhesive or isopropyl alcohol used to prepare the skin;
- skin lesions, scarring, redness, infection, or edema at the sensor application sites;
- patients whose conditions were extremely severe and not stable.
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 |
|---|---|---|
| Freestyle Libre Flash Glucose MonitoringFreestyle Libre Flash Glucose Monitoring will be used in diabetic patients once a month for therr months to monitor glucose level. Patients could scan the sensor to get the glucose level at any time as they want. They could alter thier diet and exercise according to the glucose levels. Patients will be required to keep track of food and exercise during wearing FGM sensor. Physicians would adjust patients' medication according their glucose profile provided by FGM, A1c, and diet and exercise every month. | Device | FGM group |
Primary outcome
HbA1c
Time frame: 3 months
Difference in HbA1c between intervention and control group at 3 month adjusting for baseline HbA1c
5 secondary outcomes
mean blood glucose (MBG)
Time frame: 1,2,3 months
coefficient of variation (CV)
Time frame: 1,2,3 months
area under the curve (AUC)<3.9mmol/L and >10mmol/L
Time frame: 1,2,3 months
Time in Range (TIR)
Time frame: 1,2,3 months
FGM accuracy
Time frame: during FGM
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2019.
- Derived from this study: PubMed 32858752Chen M, Li H, Shen Y, Liu B, Yan R, Sun X, Ye L, Lee KO, Ma J, Su X. Flash Glucose Monitoring Improves Glucose Control in People with Type 2 Diabetes Mellitus Receiving Anti-diabetic Drug Medication. Exp Clin Endocrinol Diabetes. 2021 Dec;129(12):857-863. doi: 10.1055/a-0994-9850. Epub 2020 Aug 28.
- Derived from this study: PubMed 32696267Hu Y, Shen Y, Yan R, Li F, Ding B, Wang H, Su X, Ma J. Relationship Between Estimated Glycosylated Hemoglobin Using Flash Glucose Monitoring and Actual Measured Glycosylated Hemoglobin in a Chinese Population. Diabetes Ther. 2020 Sep;11(9):2019-2027. doi: 10.1007/s13300-020-00879-x. Epub 2020 Jul 21.
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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.
Ma Jianhua, 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 Freestyle Libre Flash Glucose Monitoring in people with Diabetes Mellitus, 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 3 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 11 Jun 2019. 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. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ma Jianhua, MD (8625-52887092, majianhua196503@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c (time frame: 3 months). 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 NCT03785301, which also lists 2 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 11 Jun 2019.