UMIN-CTR Clinical Trial

Public title

Use of FreeStyle Libre Flash Glucose Monitoring System and the Effect on Hypoglycaemia in People with Type 2 Diabetes in Japan

Acronym

SHIFT - Study of Hypoglycaemia using FreeStyle Libre

Scientific Title

Use of FreeStyle Libre Flash Glucose Monitoring System and the Effect on Hypoglycaemia in People with Type 2 Diabetes in Japan

Scientific Title:Acronym

SHIFT - Study of Hypoglycaemia using FreeStyle Libre

Region

Japan

Condition

Type 2 Diabetes

Classification by specialty

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

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

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.

Study type

Interventional

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

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

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

Name of lead principal investigator

1st name
Middle name
Last name	Wataru Ogawa

Organization

Kobe University Graduate School of Medicine

Division name

Division of Diabetes and Endocrinology

Zip code

Address

7-5-1 Kusunoki-cho, Chuo-ku, Kobe 650-0017, Japan

TEL

078-382-5861

Email

ogawa@med.kobe-u.ac.jp

Name of contact person

1st name
Middle name
Last name	Yushi Hirota

Organization

Kobe University Hospital

Division name

Division of Diabetes and Endocrinology

Zip code

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

Institute

Abbott Diabetes Care Ltd

Institute

Department

Personal name

Organization

Abbott Diabetes Care Ltd

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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)

Date of disclosure of the study information

2016

Year

12

Month

01

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

Completed

Date of protocol fixation

2016

Year

12

Month

12

Day

Date of IRB

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

Other related information

Registered date

2016

Year

08

Month

11

Day

Last modified on

2017

Year

12

Month

23

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000027127