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Trial record 33 of 128 for:    diabetes type 1 AND (woman OR women OR female) AND Metabolism

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

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ClinicalTrials.gov Identifier: NCT03522870
Recruitment Status : Recruiting
First Posted : May 11, 2018
Last Update Posted : May 11, 2018
Sponsor:
Information provided by (Responsible Party):
Jianping Weng, Sun Yat-sen University

Brief Summary:
This trial is a randomized, multi-center, parallel group, efficacy and safety study with a 28-weeks follow- up. 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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Device: Flash glucose monitoring system Device: SMBG Not Applicable

Detailed Description:
144 Subjects with Type 1 diabetes who meet criteria will be enrolled at up to seven 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 28weeks follow-up. Secondary outcome variables such as time-in-range, frequency and duration of and hyperglycemic episodes etc. will be assessed at baseline (Week-2 to 0), Week 12-14 and Week 26-28 via wear 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  (Clinical Trial)
Estimated Enrollment : 76 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Effects of Novel Flash Glucose Monitoring System on Glycemic Control in Adult Patients With Type 1 Diabetes Mellitus
Actual Study Start Date : November 8, 2017
Estimated Primary Completion Date : December 30, 2019
Estimated Study Completion Date : December 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1
Drug Information available for: Dextrose

Arm Intervention/treatment
Experimental: Flash Glucose Monitoring System
People selected to this group will using flash glucose monitoring system continuously on Week 0-12 and Week 14-26.
Device: Flash glucose monitoring system
Using flash glucose monitoring system continuously on Week 0-12 and Week 14-26
Other Name: Freestyle Libre®;Abbott Diabetes Care,Witney, Oxon,UK

Active Comparator: SMBG
People selected to this group will using SMBG continuously on Week 0-12 and Week 14-26.
Device: SMBG
Performing SMBG at least three times/day on Week 0-12 and Week 14-26
Other Name: Capillary blood glucose tested by Bayer




Primary Outcome Measures :
  1. Glycosylated Hemoglobin A1c [ Time Frame: baseline,week12,week26 ]
    Difference in HbA1c at week 12 and week26 adjusted for baseline(week-2)

  2. Time in Hypoglycemia [ Time Frame: baseline,week12-14,week26-28 ]
    Difference in time in hypoglycaemia (<70mg/dL,<54mg/dL and<40mg/dL) assessed in week 12-14 and week 26-28 adjusted for baseline(week-2 to 0)


Secondary Outcome Measures :
  1. Percentage of HbA1c in Range [ Time Frame: baseline,week12,week26 ]
    Difference in Percentage of HbA1c at week12 and week 26 adjusted for baseline(week-2)

  2. Time in Hyperglycaemia [ Time Frame: baseline,week12-14,week26-28 ]
    Difference in time in hyperglycaemia (>180mg/dL and>300mg/dL) assessed in week 12-14 and week 26-28 adjusted for baseline(week-2 to 0)

  3. Time in Range [ Time Frame: baseline,week12-14,week26-28 ]
    Difference in time in Range (70-180 mg/dL) assessed in week 12-14 and week 26-28 adjusted for baseline(week-2 to 0)

  4. Standard deviation of glucose [ Time Frame: baseline,week12-14,week26-28 ]
    Difference in standard deviation of glucose assessed in week 12-14 and week 26-28 adjusted for baseline(week-2 to 0)

  5. Mean glucose levels [ Time Frame: baseline,week12-14,week26-28 ]
    Difference in mean glucose levels assessed in week 12-14 and week 26-28 adjusted for baseline(week-2 to 0)

  6. The area under the curve of hypoglycemia/ hyperglycaemia [ Time Frame: baseline,week12-14,week26-28 ]
  7. Frequency in hypoglycemia/ hyperglycaemia [ Time Frame: baseline,week12-14,week26-28 ]
  8. Frequency in severe hypoglycaemia [ Time Frame: baseline,week12-14,week26-28 ]
  9. Frequency in adverse events about device [ Time Frame: 28weeks ]
  10. Frequency in using FGM [ Time Frame: 28 weeks ]
  11. Frequency in SMBG [ Time Frame: 28 weeks ]
  12. Total daily dose of insulin [ Time Frame: 28 weeks ]
  13. The Diabetes Distress Scale (DDS) [ Time Frame: baseline,week 12 and week 26 ]
    Change in the Diabetes Distress Scale(DDS) score in week 12 and week 26 adjusted for baseline(week-2) is used to assess diabetes-related emotional distress. The scale consists of 17 items, based on four in participant satisfaction from baseline based a priori on four distress-related domains: emotional burden sub-scale, physician-related distress subscale, regimen-related distress subscale, and diabetes-related interpersonal distress. Each item is rated on a 7-point Likert scale.Administration time is approximately 10 minutes.

  14. Hypoglycaemia Fear Scale(HFS) [ Time Frame: baseline,week 12 and week 26 ]
    Change in Hypoglycaemia Fear Scale(HFS) score will be assessed in week 12 and week 26 adjusted for baseline(week-2).This validated survey consists of 18 questions which measure several dimensions of anxiety and fear surrounding hypoglycemia among adults with diabetes. Administration time is approximately 10 minutes.

  15. Quality of Life scale(QOLs) [ Time Frame: baseline,week 12 and week 26 ]
    Difference in QOLs assessed in week 12 and week26 adjusted for baseline(week-2)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03522870


Contacts
Contact: Jianping Weng, PHD,MD 020-85253193 wengjp@vip.163.com
Contact: Jinhua Yan, PHD,MD 020-85253193 yanjh79@163.com

Locations
China, Guangdong
The Third Affiliated Hospital of Sun Yat-sen University Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Jianping Weng, PHD,MD    020-85253193    wengjp@vip.163.com   
Contact: Jinhua Yan, PHD,MD    020-85253193    yanjh79@163.com   
Sponsors and Collaborators
Sun Yat-sen University
Investigators
Principal Investigator: Fang Liu, PHD Shanghai Jiao Tong University Affiliated Sixth People’s Hospital
Principal Investigator: Xiuzhen Li, PHD Guangzhou Women and Children's Medical Center
Principal Investigator: Zhe Su, PHD Shenzhen Children's Hospital
Principal Investigator: Puneng Wang, MD Foshan Hospital of TCM
Principal Investigator: Liling Qiu, PHD Zhongshan People's Hospital
Principal Investigator: Hongting Zheng, PHD Xinqiao Hospital of AMU

Responsible Party: Jianping Weng, Professor,Principal Investigator,Department of Endocrinology and Metabolism,The Third Affiliated Hospital, Sun Yat-sen University
ClinicalTrials.gov Identifier: NCT03522870     History of Changes
Other Study ID Numbers: CONVENIENCE
First Posted: May 11, 2018    Key Record Dates
Last Update Posted: May 11, 2018
Last Verified: April 2018

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

Keywords provided by Jianping Weng, Sun Yat-sen University:
Flash glucose monitoring system
FGMS

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases