NCT03785301

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for not_applicable diabetes-mellitus

Timeline
Completed

Started Dec 2018

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

December 20, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 24, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
Last Updated

June 11, 2019

Status Verified

August 1, 2018

Enrollment Period

11 months

First QC Date

December 20, 2018

Last Update Submit

June 9, 2019

Conditions

Diabetes Mellitus

Outcome Measures

Primary Outcomes (1)

  • HbA1c

    Difference in HbA1c between intervention and control group at 3 month adjusting for baseline HbA1c

    3 months

Secondary Outcomes (5)

  • mean blood glucose (MBG)

    1,2,3 months

  • coefficient of variation (CV)

    1,2,3 months

  • area under the curve (AUC)<3.9mmol/L and >10mmol/L

    1,2,3 months

  • Time in Range (TIR)

    1,2,3 months

  • FGM accuracy

    during FGM

Study Arms (2)

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.

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.

Interventions

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.

FGM group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \>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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nanjing First Hostital

Nanjing, Jiangsu, 210000, China

RECRUITING

Related Publications (2)

  • 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.

    PMID: 32858752DERIVED

  • Hu 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.

    PMID: 32696267DERIVED

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Ma Jianhua, MD

    The First Affiliated Hospital with Nanjing Medical University

    STUDY CHAIR

Central Study Contacts

Ma Jianhua, MD

CONTACT

8625-52887092majianhua196503@126.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 20, 2018

First Posted

December 24, 2018

Study Start

December 20, 2018

Primary Completion

October 31, 2019

Study Completion

December 31, 2019

Last Updated

June 11, 2019

Record last verified: 2018-08

Locations

CN(1)