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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000023593
Receipt No. R000027127
Official scientific title of the study Use of FreeStyle Libre Flash Glucose Monitoring System and the Effect on Hypoglycaemia in People with Type 2 Diabetes in Japan
Date of disclosure of the study information 2016/12/01
Last modified on 2017/08/12

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Basic information
Official scientific title of the study Use of FreeStyle Libre Flash Glucose Monitoring System and the Effect on Hypoglycaemia in People with Type 2 Diabetes in Japan
Title of the study (Brief title) SHIFT - Study of Hypoglycaemia using FreeStyle Libre
Region
Japan

Condition
Condition Type 2 Diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To observe the impact of using FreeStyle Libre Flash Glucose Monitoring System and the effect on hypoglycaemia in people with Type 2 diabetes in Japan.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes Change from Baseline in time in hypoglycaemia (Sensor glucose <3.9 mmol/L [70 mg/dL]) at 2.5 months.
Key secondary outcomes Change from Baseline for the following measures:Time in range (TIR) (Sensor glucose 70-180).
Number and duration of hyperglycaemic episodes (Sensor glucose >180, 240 and 300).
Number of hypoglycaemic episodes (Sensor glucose <70).
Number and duration of hypoglycaemic episodes (Sensor glucose <55 and 45).
Area under the curve (AUC) analysis for hypoglycaemic episodes (Sensor glucose <70, 55 and 45).
Number, duration and AUC analysis of hypoglycaemic episodes by day (06:00 to 23:00) and night (23:00 to 06:00) (Sensor glucose <70, 55 and 45).
Average Sensor glucose and variability measures (e.g. standard deviation [SD], Mean of Daily Differences [MODD], Low Blood Glucose Index [LBGI], High Blood Glucose Index [HBGI], Blood Glucose Risk Index [BGRI], SD of Glucose Rate of Change, Continuous Overall Net Glycaemic Action [CONGA]).
Hypoglycaemia responders, defined as subjects achieving at least a 30% reduction in time in hypoglycaemia (Sensor glucose <70).
TDD of insulin.
Body weight and body mass index.
Blood pressure.
Sub-group analysis (e.g. age group [<65, >=65 years], duration of diabetes [<20, >=20 years).
Additional analysis:
Patient Reported Outcome (PRO) (Diabetes Treatment Satisfaction Questionnaire [DTSQ]).
Hypoglycaemia patient questionnaire.
Number of Sensor scans performed.
User Questionnaire summary.
HCP Questionnaire summary.

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment No need to know

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 A prospective, multi-centre, single group trial.
Baseline phase (2 weeks) = Masked wear of the FreeStyle Libre Flash Glucose Monitoring System (Sensor results blinded to subject and health care professional [HCP]). Blood Glucose (BG) measurements to be performed using the FreeStyle Libre Flash Glucose Monitoring System (BG results visible to subject and HCP).

Main phase (2.5 months) = Un-masked wear of the FreeStyle Libre Flash Glucose Monitoring System (Sensor results visible to subject and HCP). BG measurements (as required) to be performed using the FreeStyle Libre Flash Glucose Monitoring System (results visible to subject and HCP)


Screening Visit (up to 14 days before Day 1): Screening
Visit 1 (Day 1): Start of Baseline phase
Visit 2 (Day 15): Start of Main phase
Telephone Call (Visit1+Day1)
Visit 3 (Day 30): Data upload
Visit 4 (Day 60): Data upload
Visit 5 (Day 90): Final visit

3 months per subject, plus enrolment visit; total expected duration of up to 3.5 months per subject.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria Type 2 diabetes on insulin therapy for >=6 months and on their current regimen for >=3 months prior to enrolment.
Insulin must be one of the following; an injection regimen of:
prandial insulin at least once daily,
or, prandial insulin at least once daily plus basal insulin at least once daily,
or, continuous subcutaneous insulin infusion (CSII) with no plans to change during the trial.
HbA1c >=6.0% and <=9.0% at enrolment.
Subject reports self-testing of BG levels on a regular basis equivalent to a minimum of 10 tests per week, for at least 2 months prior to enrolment.
Aged 18 years or over.
In the Investigator's opinion, the subject is proactive and therefore willing to modify their diabetes management.
In the investigator's opinion, the subject is technically capable of using device.

Key exclusion criteria Insulin regimen consists entirely of basal or a single dose of bi-phasic insulin.
Subject is currently prescribed animal insulin.
Subject is currently prescribed oral, intra-articular, intramuscular or intravenous steroid therapy for any acute or chronic condition or requires it during the study period.
Known (or suspected) allergy to medical grade adhesives.
Currently participating in another device trial or drug study that could affect glucose measurements or glucose management.
Currently using a Continuous Glucose Monitoring (CGM) device and FreeStyle Libre or has used one within the previous 4 months.
Is planning to use a CGM device at any time during the trial.
Total daily dose (TDD) of insulin >1.75 iu/kg at enrolment.
Currently receiving dialysis treatment or planning to receive dialysis during the trial.
Has experienced an acute myocardial infarction within previous 6 months.
Has a concomitant disease or condition that may compromise patient safety, including and not limited to; unstable coronary heart disease, cystic fibrosis, severe mental illness, known or suspected eating disorder or any other uncontrolled long term medical condition.
Has a pacemaker or any other neurostimulators.
A female subject who is pregnant or planning to become pregnant within the trial duration.
In the investigator's opinion, the subject is unsuitable to participate due to any other cause/reason.
Target sample size 95

Research contact person
Name of lead principal investigator Wataru Ogawa
Organization Kobe University Graduate School of Medicine
Division name Division of Diabetes and Endocrinology
Address 7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL 078-382-5861
Email ogawa@med.kobe-u.ac.jp

Public contact
Name of contact person Yushi Hirota
Organization Kobe University Hospital
Division name Division of Diabetes and Endocrinology
Address 7-5-2 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan
TEL 078-382-5861
Homepage URL
Email hirota@med.kobe-u.ac.jp

Sponsor
Institute Abbott Diabetes Care Ltd
Institute
Department

Funding Source
Organization Abbott Diabetes Care Ltd
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions 神戸大学医学部附属病院 (Kobe University Hospital)
東京慈恵会医科大学附属病院 (The Jikei University Hospital)
愛知医科大学病院 (Aichi Medical University Hospital)
糖尿病・内分泌内科クリニックTOSAKI (TDE Healthcare Corporation TOSAKI Clinic for Diabetes and Endocrinology)
医療法人健清会 那珂記念クリニック(Iryo Houjin Kenseikai NAKAKINEN CLINIC)



Other administrative information
Date of disclosure of the study information
2016 Year 12 Month 01 Day

Progress
Recruitment status No longer recruiting
Date of protocol fixation
2016 Year 12 Month 12 Day
Anticipated trial start date
2017 Year 02 Month 01 Day
Last follow-up date
2017 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2016 Year 08 Month 11 Day
Last modified on
2017 Year 08 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027127

Research Plan
Registered date Registrant File name

Research case data specifications
Registered date Registrant File name

Research case data
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