Condition category
Nutritional, Metabolic, Endocrine
Date applied
20/12/2004
Date assigned
09/02/2005
Last edited
18/02/2008
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 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 Children’s 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

  1. 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.

Additional files

Editorial Notes