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

Primary Purpose

Diabetes Mellitus, Type 1

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Flash glucose monitoring system
SMBG
Sponsored by
Sun Yat-sen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 1 focused on measuring Flash glucose monitoring system, FGMS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • The Third Affiliated Hospital of Sun Yat-sen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Flash Glucose Monitoring System

SMBG

Arm Description

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

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

Outcomes

Primary Outcome Measures

Glycosylated Hemoglobin A1c
Difference in HbA1c at week 14 and week26 adjusted for baseline(week 0)

Secondary Outcome Measures

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)
Time in Hypoglycemia
Difference in time in hypoglycaemia (<70mg/dL,<54mg/dL and<40mg/dL) assessed in week 12-14 and week 24-26 adjusted for baseline(week 0 to 2)
Time in Hyperglycaemia
Difference in time in hyperglycaemia (>180mg/dL and>300mg/dL) assessed in week 12-14 and week 24-26 adjusted for baseline(week 0 to 2)
Percentage of HbA1c in Range
Difference in Percentage of HbA1c at week14 and week 26 adjusted for baseline(week 0)
Standard deviation of glucose
Difference in standard deviation of glucose assessed in week 12-14 and week 24-26 adjusted for baseline(week 0 to 2)
Mean glucose levels
Difference in mean glucose levels assessed in week 12-14 and week 24-26 adjusted for baseline(week0 to 2)
The area under the curve of hypoglycemia/ hyperglycaemia
Frequency in hypoglycemia/ hyperglycaemia
Frequency in severe hypoglycaemia
Frequency in adverse events about device
Frequency in using FGM
Frequency in SMBG
Total daily dose of insulin
The Diabetes Distress Scale (DDS)
The Chinese version of the Diabetes Distress Scale is to evaluate diabetes-related emotional distress in Chinses diabetic patients. The scale consists of 17 items, contains four domains including emotional burden sub-scale, physician-related distress subscale, regimen-related distress subscale, and diabetes-related interpersonal distress. Each item is rated on a 6-point Likert scale from 1(no problem) to 6(serious problem). An average score ≥3 is the cut-off point which is considered to more than moderate problem. Administration time is approximately 10 minutes.
Hypoglycaemia Fear Scale(HFS)
The Chinses version of Hypoglycemia Fear Survey II- Worry Scale (CHFSII-WS) is to evaluate psychological status for diabetic patients. Change in Hypoglycemia Fear Scale (HFS) score will be assessed in week 14 and week 26 adjusted for baseline(week0). These validated surveys consist of 18 questions which measure dimensions of anxiety and fear surrounding hypoglycemia. Each item is rated on 5-point Likert scale from 0(never related) to 4(very related). "Never relative" scores 1, and so on and so forth, and "very related" scores 4. Patients with higher scores are considered with more anxieties and fear of hypoglycemia. Administration time is approximately 10 minutes.
EQ-5D-5L
The Chinese version of the EQ-5D-5L is widely used to evaluate quality of life. The EQ-5D-5L is converted to a single summary index by applying a formula that essentially attaches weights to each of the levels in each dimension. The formula is based on the valuation of EQ-5D health states from general population samples. It contains the health description system and Visual Analogue Score (VAS). The health description system includes 5 dimensions including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each item is rated on 5 levels from 1(no problems) to 5(extreme problem). And the EQ-VAS is to evaluate the health condition assessed by patients. The top score (100) means the best health conditions and the bottom one (0) means the worst. Administration time is approximately 3minutes. Difference in EQ-5D-5Ls assessed in week 14 and week26 adjusted for baseline(week0-2).

Full Information

First Posted
April 18, 2018
Last Updated
February 8, 2023
Sponsor
Sun Yat-sen University
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1. Study Identification

Unique Protocol Identification Number
NCT03522870
Brief Title
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

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 1, 2018 (Actual)
Primary Completion Date
June 19, 2022 (Actual)
Study Completion Date
June 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Sun Yat-sen University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 1
Keywords
Flash glucose monitoring system, FGMS

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Flash Glucose Monitoring System
Arm Type
Experimental
Arm Description
People selected to this group will using flash glucose monitoring system continuously on Week 2-14 and Week 14-26.
Arm Title
SMBG
Arm Type
Active Comparator
Arm Description
People selected to this group will using SMBG continuously on Week 2-14 and Week 14-26.
Intervention Type
Device
Intervention Name(s)
Flash glucose monitoring system
Other Intervention Name(s)
Freestyle Libre®;Abbott Diabetes Care,Witney, Oxon,UK
Intervention Description
Using flash glucose monitoring system continuously on Week 2-14 and Week 14-26
Intervention Type
Device
Intervention Name(s)
SMBG
Other Intervention Name(s)
Capillary blood glucose tested by Bayer
Intervention Description
Performing SMBG at least three times/day on Week 2-14 and Week 14-26
Primary Outcome Measure Information:
Title
Glycosylated Hemoglobin A1c
Description
Difference in HbA1c at week 14 and week26 adjusted for baseline(week 0)
Time Frame
baseline,week14,week26
Secondary Outcome Measure Information:
Title
Time in Range
Description
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)
Time Frame
baseline,week12-14,week24-26
Title
Time in Hypoglycemia
Description
Difference in time in hypoglycaemia (<70mg/dL,<54mg/dL and<40mg/dL) assessed in week 12-14 and week 24-26 adjusted for baseline(week 0 to 2)
Time Frame
baseline,week12-14,week24-26
Title
Time in Hyperglycaemia
Description
Difference in time in hyperglycaemia (>180mg/dL and>300mg/dL) assessed in week 12-14 and week 24-26 adjusted for baseline(week 0 to 2)
Time Frame
baseline,week12-14,week24-26
Title
Percentage of HbA1c in Range
Description
Difference in Percentage of HbA1c at week14 and week 26 adjusted for baseline(week 0)
Time Frame
baseline,week14,week26
Title
Standard deviation of glucose
Description
Difference in standard deviation of glucose assessed in week 12-14 and week 24-26 adjusted for baseline(week 0 to 2)
Time Frame
baseline,week12-14,week24-26
Title
Mean glucose levels
Description
Difference in mean glucose levels assessed in week 12-14 and week 24-26 adjusted for baseline(week0 to 2)
Time Frame
baseline,week12-14,week24-26
Title
The area under the curve of hypoglycemia/ hyperglycaemia
Time Frame
baseline,week12-14,week24-26
Title
Frequency in hypoglycemia/ hyperglycaemia
Time Frame
baseline,week12-14,week24-26
Title
Frequency in severe hypoglycaemia
Time Frame
baseline,week12-14,week24-26
Title
Frequency in adverse events about device
Time Frame
26weeks
Title
Frequency in using FGM
Time Frame
24 weeks
Title
Frequency in SMBG
Time Frame
26 weeks
Title
Total daily dose of insulin
Time Frame
26 weeks
Title
The Diabetes Distress Scale (DDS)
Description
The Chinese version of the Diabetes Distress Scale is to evaluate diabetes-related emotional distress in Chinses diabetic patients. The scale consists of 17 items, contains four domains including emotional burden sub-scale, physician-related distress subscale, regimen-related distress subscale, and diabetes-related interpersonal distress. Each item is rated on a 6-point Likert scale from 1(no problem) to 6(serious problem). An average score ≥3 is the cut-off point which is considered to more than moderate problem. Administration time is approximately 10 minutes.
Time Frame
baseline,week 14 and week 26
Title
Hypoglycaemia Fear Scale(HFS)
Description
The Chinses version of Hypoglycemia Fear Survey II- Worry Scale (CHFSII-WS) is to evaluate psychological status for diabetic patients. Change in Hypoglycemia Fear Scale (HFS) score will be assessed in week 14 and week 26 adjusted for baseline(week0). These validated surveys consist of 18 questions which measure dimensions of anxiety and fear surrounding hypoglycemia. Each item is rated on 5-point Likert scale from 0(never related) to 4(very related). "Never relative" scores 1, and so on and so forth, and "very related" scores 4. Patients with higher scores are considered with more anxieties and fear of hypoglycemia. Administration time is approximately 10 minutes.
Time Frame
baseline,week 14 and week 26
Title
EQ-5D-5L
Description
The Chinese version of the EQ-5D-5L is widely used to evaluate quality of life. The EQ-5D-5L is converted to a single summary index by applying a formula that essentially attaches weights to each of the levels in each dimension. The formula is based on the valuation of EQ-5D health states from general population samples. It contains the health description system and Visual Analogue Score (VAS). The health description system includes 5 dimensions including mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each item is rated on 5 levels from 1(no problems) to 5(extreme problem). And the EQ-VAS is to evaluate the health condition assessed by patients. The top score (100) means the best health conditions and the bottom one (0) means the worst. Administration time is approximately 3minutes. Difference in EQ-5D-5Ls assessed in week 14 and week26 adjusted for baseline(week0-2).
Time Frame
baseline,week 14 and week 26

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Xueying Zheng, MD
Organizational Affiliation
The First Affiliated Hospital of USTC
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jing Lu, PHD
Organizational Affiliation
Department of Endocrinology, Nanjing Drum Tower Hospital Affiliated to Nanjing University Medical School, Nanjing, China.
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Third Affiliated Hospital of Sun Yat-sen University
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510080
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
33277281
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.
Results Reference
background
PubMed Identifier
32551036
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.
Results Reference
result
PubMed Identifier
36670050
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.
Results Reference
result
PubMed Identifier
35864804
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.
Results Reference
result

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

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