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 |
| Protocol serial number | 2001/012 |
| Sponsor | Institute of Endocrinology and Diabetes, The Children's Hospital at Westmead |
| Funders | Australian Diabetes Society (Australia) - Servier National Action Plan Grant for 2004 (Australia), Novo Nordisk (Australia) - Regional Diabetes Support Scheme 2005 grant, Medtronic Australasia Pty Ltd (Australia) - donating CGMS sensors and loaning monitors |
- 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
Scientific
Institute of Endocrinology and Diabetes
The Children's Hospital
Locked Bag 4001
Westmead NSW
2145
Australia
| Phone | +61 (0)2 9845 3151 |
|---|---|
| kyliey@chw.edu.au |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| 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(s) |
Diabetes control, measured using HbA1c and fructosamine measured at baseline and 6 and 12 weeks. |
| Key secondary outcome measure(s) |
1. HbA1c, measured using ion-exchange high-pressure liquid chromatography (Bio-Rad Laboratories) |
| Completion date | 30/09/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 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 |
Locations
Countries of recruitment
- Australia
Study participating centre
Institute of Endocrinology and Diabetes
Westmead NSW
2145
Australia
2145
Australia
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not 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.
