Effects of Novel Flash Glucose Monitoring System on Glycemic Control in Adult Patients With Type 1 Diabetes Mellitus

Sun Yat-sen University104 enrolled

Overview

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.

Subjects with Type 1 diabetes who meet criteria will be enrolled at up to eight clinical research sites in China. Subjects will be randomized to either flash glucose monitoring system(Freestyle Libre®;Abbott Diabetes Care,Witney, Oxon,UK) or conventional Self Measurement of Blood Glucose (Bayer®)alone at least three times per day. Primary outcome variable is the difference in HbA1c which will be analyzed in a central laboratory between baseline and the 26weeks follow-up. Secondary outcome variables such as time-in-range, frequency and duration of and hyperglycemic episodes etc. will be assessed at baseline (Week 0 to 2), Week 12-14 and Week 24-26 via professional continuous glucose system (Ipro2®; Medtronic). At the same time, demographic factors, clinical data, patient reported outcome (PROs) will be collected. Assessment of Adverse Events will occur via self-reporting at each visit and/or phone call. All patients will receive same ordinary diabetes education.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

104

Conditions

Diabetes Mellitus, Type 1

Interventions

Flash glucose monitoring systemDEVICE

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

SMBGDEVICE

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

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Aged 18 years and older; 2. Diagnosed with type 1 diabetes with the criteria established by WHO in 1999,with duration more than 1 year; 3. Glycosylated Hemoglobin A1c concentration between 7% and 10%; 4. 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 5. Using CSII or MDI for at least 3 months, stable diabetes medication regimen for 3 months prior to study entry(change in insulin ≦20%). 6. Willing to wear CGM; 7. Able to speak, read, and write Chinese Exclusion Criteria: 1. Having used CGM 3 months prior to study entry; 2. Had severe diabetic complications such as PDR in diabetic retinopathy and ESRD of diabetic nephropathy, assessed by investigators; 3. Receiving oral steroid therapy for any disorders and continuous use of paracetamol. 4. Had known allergy to medical-grade adhesives or CGM and its affiliated components; 5. Being pregnant or planning pregnancy (as demonstrated by a positive test at study entry); 6. Recent severe diseases like myocardial infarction,stroke,psychiatric diseases(historical/recent),malignant tumor, kidney disease(defined as eGFR\<45), dermatosis, decided by investigator. 7. Current participation in another investigational study (must have completed any previous studies at least 30 days prior to being enrolled in this study); 8. Currently abusing illicit drugs, alcohol, or prescription drugs; 9. Any condition that could impact reliability of the HbA1C measurement,（e.g.hemoglobinopathy, hemolytic anemia, chronic liver disease),decided by investigator.

Locations (1)

The Third Affiliated Hospital of Sun Yat-sen University

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Glycosylated Hemoglobin A1c

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

Time frame: baseline,week14,week26

Secondary Outcomes

Time in Range

Difference in time in Range (70-180 mg/dL) assessed in week 12-14 and week 24-26 adjusted for baseline(week 0 to 2)