UMIN-CTR Clinical Trial

Public title

Telemonitoring System for Patients with Diabetes: a randomised controlled trial.

Acronym

Telemonitoring System for Patients with Diabetes

Scientific Title

Telemonitoring System for Patients with Diabetes: a randomised controlled trial.

Scientific Title:Acronym

Telemonitoring System for Patients with Diabetes

Region

Japan

Condition

diabettes, impaired glucose tolerance

Classification by specialty

Medicine in general

Endocrinology and Metabolism

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To evaluate the usefulness of home telemonitoring system using multi-functional mobile phone for patients with diabettes or impaired glucose tolerance

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Not applicable

Primary outcomes

following items before and 3 months after the introduction of home telemonitoring system
1 plasma glucose level, HbA1C
2 Urine alubumin excretion
3 Lipid levels
4 Blood pressure
5 Body weight, Body Mass Index
6 Diabetic complication
7 newly required medicine for diabetes, blood pressure, or dyslipidemia

Key secondary outcomes

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Blinding

Open -no one is blinded

Control

No treatment

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Behavior,custom

Interventions/Control_1

Intervention group: Home telemonitoring system using multi-functional mobile phone for 3 months

1) Every day: records of meals(photos), body weight, amount of exercise(number of steps, blood pressure)
2) Once a month: plasma glucose levels, HbA1C and measured, and the excretion of urinary albumin at home

Above data are sent from home to Aoki Health Network by the mobile phone.
Based on the data, the guidance of diet and exercise are performed by e-mails using mobile phone.

3) Three months after the start of study, blood samples are taken to be compared with those in the control group.

Period of the study: from the day of approval to April 30, 2010

Interventions/Control_2

control group:During 3 months of the study, Patients are only followed.

3 months after the start of the study, blood samples are taken to be compred with those in the intervention group.

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

19

years-old

<=

Age-upper limit

74

years-old

>=

Gender

Male and Female

Key inclusion criteria

1) Patients with untreated diabetes or impaired glucose tolerance
2) HbA1C 5.2~6.4%
3) Patients with untreated hypertension or dyslipidemia
4) Patients whose content is obtained in written form

Key exclusion criteria

1) Patients with malignant hypertension or secondary hypertension
2) Diabetic patients requiring medical treatment
3) Pregnant and probably pregnant patients
4) patients with abnormal serum creatinin value
5) Patients with severe hepatic dysfunction
6) Patients who had myocardial infarction or apoplexy within 3 months before the satrt of the study or who are treated.
7) Patients with severe allergy or with treatment by steroid
8) Patients with pancreatitis or pasthistory of pancreatitis
9) Patients with malignacy
10) other patients judged as being inappropriate for the subjects of the study by investigators

Target sample size

100

Name of lead principal investigator

1st name
Middle name
Last name	Takashi Yoneda

Organization

Kanazawa University

Division name

Kanazawa University Hospital

Zip code

Address

Takaramachi13-1, Kanazawa, Japan, 9208640

TEL

+81762652252

Email

Name of contact person

1st name
Middle name
Last name	Takashi Yoneda

Organization

Kanazawa University

Division name

Kanazawa University Hospital

Zip code

Address

Takaramachi13-1, Kanazawa, Japan

TEL

+81762652252

Homepage URL

Email

Institute

Kanazawa University Hospital,Department of Endocrinology and Metabolism

Institute

Department

Personal name

Organization

Kanazawa University

Organization

Division

Category of Funding Organization

Self funding

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

能美市（石川県）

Date of disclosure of the study information

2013

Year

07

Month

16

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

2009

Year

11

Month

16

Day

Date of IRB

Anticipated trial start date

2009

Year

11

Month

16

Day

Last follow-up date

2010

Year

04

Month

30

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2013

Year

07

Month

16

Day

Last modified on

2013

Year

07

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013132