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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

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 design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Scientific title	Utility of continuous glucose monitoring (CGMS) in children with type I diabetes on intensive treatment regimens
Study objectives	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(s)	This study was approved by the ethics committee of The Childrens Hospital Westmead.
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/05/2004
Completion date	30/09/2004

Participant type(s)	Patient
Age group	Child
Upper age limit	18 Years
Sex	Both
Target number of participants	35
Key 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.
Key exclusion criteria	1. Known poor compliance 2. HbA1c greater than 10%
Date of first enrolment	01/05/2004
Date of final enrolment	30/09/2004

Institute of Endocrinology and Diabetes

Westmead NSW
2145
Australia

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

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

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

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

20/01/2020: Internal review.