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 measure
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 (if study stopped)
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
Basic results (scientific)
Publication list
2001 results on http://www.ncbi.nlm.nih.gov/pubmed/11265938
Publication citations
-
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.