NCT03522870

Brief Summary

This trial is a randomized, multi-center, parallel-group, efficacy and safety study with a 26-weeks follow- up(after 2-week recruitment). The study aims to: 1)compare the effects of novel flash glucose monitoring system (FGMS) and conventional Self Measurement of Blood Glucose (SMBG); and 2) optimize integrated management for glycaemic control in adult patients with type 1 diabetes who are sub-optimally controlled.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
104

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

April 18, 2018

Completed
13 days until next milestone

Study Start

First participant enrolled

May 1, 2018

Completed
10 days until next milestone

First Posted

Study publicly available on registry

May 11, 2018

Completed
4.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 19, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 19, 2022

Completed
Last Updated

February 10, 2023

Status Verified

February 1, 2023

Enrollment Period

4.1 years

First QC Date

April 18, 2018

Last Update Submit

February 8, 2023

Conditions

Diabetes Mellitus, Type 1

Keywords

Flash glucose monitoring systemFGMS

Outcome Measures

Primary Outcomes (1)

  • Glycosylated Hemoglobin A1c

    Difference in HbA1c at week 14 and week26 adjusted for baseline(week 0)

    baseline,week14,week26

Secondary Outcomes (16)

  • Time in Range

    baseline,week12-14,week24-26

  • Time in Hypoglycemia

    baseline,week12-14,week24-26

  • Time in Hyperglycaemia

    baseline,week12-14,week24-26

  • Percentage of HbA1c in Range

    baseline,week14,week26

  • Standard deviation of glucose

    baseline,week12-14,week24-26

  • +11 more secondary outcomes

Study Arms (2)

Flash Glucose Monitoring System

EXPERIMENTAL

People selected to this group will using flash glucose monitoring system continuously on Week 2-14 and Week 14-26.

Device: Flash glucose monitoring system

SMBG

ACTIVE COMPARATOR

People selected to this group will using SMBG continuously on Week 2-14 and Week 14-26.

Device: SMBG

Interventions

Flash glucose monitoring systemDEVICE

Using flash glucose monitoring system continuously on Week 2-14 and Week 14-26

Also known as: Freestyle Libre®;Abbott Diabetes Care,Witney, Oxon,UK
Flash Glucose Monitoring System
SMBGDEVICE

Performing SMBG at least three times/day on Week 2-14 and Week 14-26

Also known as: Capillary blood glucose tested by Bayer
SMBG

Eligibility Criteria

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

You may qualify if:

  • Aged 18 years and older;
  • Diagnosed with type 1 diabetes with the criteria established by WHO in 1999,with duration more than 1 year;
  • Glycosylated Hemoglobin A1c concentration between 7% and 10%;
  • Self-monitor of blood glucose levels on a regular basis for 2 months previous( at least 3 times per day) and have willing to insist for at least 6 months
  • Using CSII or MDI for at least 3 months, stable diabetes medication regimen for 3 months prior to study entry(change in insulin ≦20%).
  • Willing to wear CGM;
  • Able to speak, read, and write Chinese

You may not qualify if:

  • Having used CGM 3 months prior to study entry;
  • Had severe diabetic complications such as PDR in diabetic retinopathy and ESRD of diabetic nephropathy, assessed by investigators;
  • Receiving oral steroid therapy for any disorders and continuous use of paracetamol.
  • Had known allergy to medical-grade adhesives or CGM and its affiliated components;
  • Being pregnant or planning pregnancy (as demonstrated by a positive test at study entry);
  • Recent severe diseases like myocardial infarction,stroke,psychiatric diseases(historical/recent),malignant tumor, kidney disease(defined as eGFR\<45), dermatosis, decided by investigator.
  • Current participation in another investigational study (must have completed any previous studies at least 30 days prior to being enrolled in this study);
  • Currently abusing illicit drugs, alcohol, or prescription drugs;
  • Any condition that could impact reliability of the HbA1C measurement,（e.g.hemoglobinopathy, hemolytic anemia, chronic liver disease),decided by investigator.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, 510080, China

Location

Related Publications (4)

  • Zhou Y, Deng H, Liu H, Yang D, Xu W, Yao B, Yan J, Weng J. Effects of novel flash glucose monitoring system on glycaemic control in adult patients with type 1 diabetes mellitus: protocol of a multicentre randomised controlled trial. BMJ Open. 2020 Dec 4;10(12):e039400. doi: 10.1136/bmjopen-2020-039400.

    PMID: 33277281BACKGROUND

  • Liu H, Yang D, Deng H, Xu W, Lv J, Zhou Y, Luo S, Zheng X, Liang H, Yao B, Qiu L, Wang F, Liu F, Yan J, Weng J. Impacts of glycemic variability on the relationship between glucose management indicator from iPro2 and laboratory hemoglobin A1c in adult patients with type 1 diabetes mellitus. Ther Adv Endocrinol Metab. 2020 Jun 8;11:2042018820931664. doi: 10.1177/2042018820931664. eCollection 2020.

    PMID: 32551036RESULT

  • Yan J, Zhou Y, Zheng X, Zheng M, Lu J, Luo S, Yang D, Deng H, Xu W, Bi Y, Bao W, Weng J. Effects of intermittently scanned continuous glucose monitoring in adult type 1 diabetes patients with suboptimal glycaemic control: A multi-centre randomized controlled trial. Diabetes Metab Res Rev. 2023 May;39(4):e3614. doi: 10.1002/dmrr.3614. Epub 2023 Feb 7.

    PMID: 36670050RESULT

  • Zhou Y, Mai X, Deng H, Yang D, Zheng M, Huang B, Xu L, Weng J, Xu W, Yan J. Discrepancies in glycemic metrics derived from different continuous glucose monitoring systems in adult patients with type 1 diabetes mellitus. J Diabetes. 2022 Jul;14(7):476-484. doi: 10.1111/1753-0407.13296. Epub 2022 Jul 21.

    PMID: 35864804RESULT

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • Xueying Zheng, MD

    The First Affiliated Hospital of USTC

    PRINCIPAL INVESTIGATOR

  • Jing Lu, PHD

    Department of Endocrinology, Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School, Nanjing, China.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor,Principal Investigator,Department of Endocrinology and Metabolism，The Third Affiliated Hospital

Study Record Dates

First Submitted

April 18, 2018

First Posted

May 11, 2018

Study Start

May 1, 2018

Primary Completion

June 19, 2022

Study Completion

June 19, 2022

Last Updated

February 10, 2023

Record last verified: 2023-02

Locations

CN(1)