Contact information
Type
Scientific
Primary contact
Dr Kylie Yates
ORCID ID
Contact details
Institute of Endocrinology and Diabetes
The Children's Hospital
Locked Bag 4001
Westmead NSW
2145
Australia
+61 (0)2 9845 3151
kyliey@chw.edu.au
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2001/012
Study information
Scientific title
Acronym
Study hypothesis
The purpose of this study was to assess the effect on diabetes control of guiding insulin adjustment with four cycles of CGMS over 3 months in children on near-physiological insulin replacement regimen.
Ethics approval
This study was approved by the ethics committee of The Childrens Hospital Westmead.
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Condition
Diabetes
Intervention
Two arms:
1. Intervention arm has CGMS monitoring for 3 days every 3 weeks over a 3 month period (4 cycles)
2. Control arm that continues traditional intermittent blood glucose level (BGL) monitoring
Each 3 weeks, the insulin doses will be reviewed and adjusted based on either the CGMS or intermittent BGL data. Change in HbA1c will be compared between the two groups.
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measures
Diabetes control, measured using HbA1c and fructosamine measured at baseline and 6 and 12 weeks.
Secondary outcome measures
1. HbA1c, measured using ion-exchange high-pressure liquid chromatography (Bio-Rad Laboratories)
2. Fructosamine, measured using Cobras Integras system
Overall trial start date
01/05/2004
Overall trial end date
30/09/2004
Reason abandoned
Eligibility
Participant inclusion criteria
Children and adolescents aged 18 years or less with type one diabetes on either an insulin pump or an intensive insulin plan that includes insulin glargine (Lantus) for at least 3 months.
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
35
Participant exclusion criteria
1. Known poor compliance
2. HbA1c greater than 10%
Recruitment start date
01/05/2004
Recruitment end date
30/09/2004
Locations
Countries of recruitment
Australia
Trial participating centre
Institute of Endocrinology and Diabetes
Westmead NSW
2145
Australia
Sponsor information
Organisation
Institute of Endocrinology and Diabetes (Australia)
Sponsor details
The Children's Hospital
Westmead
Locked bag 4001
Westmead NSW
2145
Australia
+61 (0)2 9845 3151
kyliey@chw.edu.au
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Industry
Funder name
Australian Diabetes Society (Australia) - Servier National Action Plan Grant for 2004 (Australia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Novo Nordisk (Australia) - Regional Diabetes Support Scheme 2005 grant
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Medtronic Australasia Pty Ltd (Australia) - donating CGMS sensors and loaning monitors
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
Results in http://www.ncbi.nlm.nih.gov/pubmed/16801571
Publication citations
-
Results
Yates K, Hasnat Milton A, Dear K, Ambler G, Continuous glucose monitoring-guided insulin adjustment in children and adolescents on near-physiological insulin regimens: a randomized controlled trial., Diabetes Care, 2006, 29, 7, 1512-1517, doi: 10.2337/dc05-2315.