Clinical trial NCT03522870: Effects of Novel Flash Glucose Monitoring System on Glycemic Control in Adult Patients With Type 1 Diabetes Mellitus
Official title: Effects of Novel Flash Glucose Monitoring System on Glycemic Control in Adult Patients With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 1
Keywords: Flash glucose monitoring system
FGMS
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 104
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Glycosylated Hemoglobin A1c
timeFrame: baseline,week14,week26
Secondary outcomes:
measure: Time in Range
timeFrame: baseline,week12-14,week24-26
measure: Time in Hypoglycemia
timeFrame: baseline,week12-14,week24-26
measure: Time in Hyperglycaemia
timeFrame: baseline,week12-14,week24-26
measure: Percentage of HbA1c in Range
timeFrame: baseline,week14,week26
measure: Standard deviation of glucose
timeFrame: baseline,week12-14,week24-26
measure: Mean glucose levels
timeFrame: baseline,week12-14,week24-26
measure: The area under the curve of hypoglycemia/ hyperglycaemia
timeFrame: baseline,week12-14,week24-26
measure: Frequency in hypoglycemia/ hyperglycaemia
timeFrame: baseline,week12-14,week24-26
measure: Frequency in severe hypoglycaemia
timeFrame: baseline,week12-14,week24-26
measure: Frequency in adverse events about device
timeFrame: 26weeks
measure: Frequency in using FGM
timeFrame: 24 weeks
measure: Frequency in SMBG
timeFrame: 26 weeks
measure: Total daily dose of insulin
timeFrame: 26 weeks
measure: The Diabetes Distress Scale (DDS)
timeFrame: baseline,week 14 and week 26
measure: Hypoglycaemia Fear Scale(HFS)
timeFrame: baseline,week 14 and week 26
measure: EQ-5D-5L
timeFrame: baseline,week 14 and week 26
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The Third Affiliated Hospital of Sun Yat-sen University
state: Guangdong
Study officials:
affiliation: The First Affiliated Hospital of USTC
name: Xueying Zheng, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Department of Endocrinology, Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School, Nanjing, China.
name: Jing Lu, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.