Condition category
Nutritional, Metabolic, Endocrine
Date applied
10/10/2002
Date assigned
10/10/2002
Last edited
02/07/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr MW Tsang

ORCID ID

Contact details

Department of Medicine & Geriatrics
United Christian Hospital
Kwun Tong
-
Hong Kong

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

722006

Study information

Scientific title

Acronym

Study hypothesis

By using a remote log-in system, Vtech 8300, the 24-hour free access to the Diabetes Monitoring System (DMS) can be usefully employed to educate and reinforce the ditetic knowledge of diabetic patients. The immediate feedback mechanism can motivate and elicit their co-operation in the long-term management of their diabetic condition. This will result in an improvement in their sugar control.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Diabetes

Intervention

Patients were randomly assigned to the control group or the Vtech CV 8300 study group accordingly:
1. Study group: Each patient was issued a Vtech CV 8300 device. Home blood sugar data were collected. Calculations were done and immediate feedback on calories and nutrients were sent back to the patient
2. Control group: They would not have the Vtech CV 8300 or additional support apart from the usual follow up routine

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Metabolic: metabolic control in terms of change in glycosylated haemoglobin A1c
(HbA1c) over the whole study period was measured and compared
2. Acceptability of DMS: a questionnaire was given to the participant after the study to
access the acceptability and satisfaction with the DMS

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2000

Overall trial end date

01/01/2002

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged between 18 - 50 years
2. Duration since diagnosis greater than 1 year
3. Diabetes on insulin therapy
4. On home blood glucose monitoring at least twice a week
5. No active diabetic maculopathy or retinopathy: pre-proliferating, proliferate or vitreous haemorrhage
6. No clinical evidence of coronary heart disease
7. Willingness to learn simple operations with data entry and log-in through the Vtech CV 8300

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

20 (10 in each group)

Participant exclusion criteria

1. Poor compliance
2. Active eye complication
3. Unstable coronary heart disease

Recruitment start date

01/01/2000

Recruitment end date

01/01/2002

Locations

Countries of recruitment

Hong Kong

Trial participating centre

Department of Medicine & Geriatrics
Kwun Tong
-
Hong Kong

Sponsor information

Organisation

Hong Kong Health Services Research Fund (Hong Kong)

Sponsor details

Health Welfare and Food Bureau
Government Secretariat
HKSAR
20th floor Murray Building
Garden Road
-
-
Hong Kong
+852 (0)2973 8288
hsrf@hwfb.gov.hk

Sponsor type

Government

Website

http://www.fhb.gov.hk/grants/english/funds/funds_hhsrf/funds_hhsrf_abt/funds_hhsrf_abt.html

Funders

Funder type

Government

Funder name

Hong Kong Health Services Research Fund (Hong Kong)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2001 results on http://www.ncbi.nlm.nih.gov/pubmed/11265938

Publication citations

  1. Results

    Tsang MW, Mok M, Kam G, Jung M, Tang A, Chan U, Chu CM, Li I, Chan J, Improvement in diabetes control with a monitoring system based on a hand-held, touch-screen electronic diary., J Telemed Telecare, 2001, 7, 1, 47-50.

Additional files

Editorial Notes