UMIN-CTR Clinical Trial

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]). 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: rapid-acting insulin at least once daily, or, rapid-acting 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 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 or 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	Completed
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 12 Month 23 Day

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