Utility of continuous glucose monitoring (CGMS) in children with type I diabetes on intensive treatment regimens

ISRCTN ISRCTN28387915
DOI https://doi.org/10.1186/ISRCTN28387915
Secondary identifying numbers 2001/012
Submission date
20/12/2004
Registration date
09/02/2005
Last edited
20/01/2020
Recruitment status
No longer recruiting
Overall study status
Completed
Condition category
Nutritional, Metabolic, Endocrine
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr Kylie Yates
Scientific

Institute of Endocrinology and Diabetes
The Children's Hospital
Locked Bag 4001
Westmead NSW
2145
Australia

Phone +61 (0)2 9845 3151
Email kyliey@chw.edu.au

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Hospital
Study typeTreatment
Scientific titleUtility of continuous glucose monitoring (CGMS) in children with type I diabetes on intensive treatment regimens
Study objectivesThe 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(s)This study was approved by the ethics committee of The Children’s Hospital Westmead.
Health condition(s) or problem(s) studiedDiabetes
InterventionTwo 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 typeOther
Primary outcome measureDiabetes control, measured using HbA1c and fructosamine measured at baseline and 6 and 12 weeks.
Secondary outcome measures1. HbA1c, measured using ion-exchange high-pressure liquid chromatography (Bio-Rad Laboratories)
2. Fructosamine, measured using Cobras Integras system
Overall study start date01/05/2004
Completion date30/09/2004

Eligibility

Participant type(s)Patient
Age groupChild
Upper age limit18 Years
SexBoth
Target number of participants35
Key inclusion criteriaChildren 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.
Key exclusion criteria1. Known poor compliance
2. HbA1c greater than 10%
Date of first enrolment01/05/2004
Date of final enrolment30/09/2004

Locations

Countries of recruitment

  • Australia

Study participating centre

Institute of Endocrinology and Diabetes
Westmead NSW
2145
Australia

Sponsor information

Institute of Endocrinology and Diabetes, The Children's Hospital at Westmead
Hospital/treatment centre

The Children's Hospital, Westmead
Locked bag 4001
Westmead NSW
2145
Australia

Phone +61 (0)2 9845 3151
Email kyliey@chw.edu.au
ROR logo "ROR" https://ror.org/05k0s5494

Funders

Funder type

Industry

Australian Diabetes Society (Australia) - Servier National Action Plan Grant for 2004 (Australia)

No information available

Novo Nordisk (Australia) - Regional Diabetes Support Scheme 2005 grant

No information available

Medtronic Australasia Pty Ltd (Australia) - donating CGMS sensors and loaning monitors

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results 01/07/2006 Yes No

Editorial Notes

20/01/2020: Internal review.