Type 1 DiabetesNCT00748137
Bolus Insulin Card Calculator Randomised Controlled Study
A study testing ezy-BICC dose calculation card and Fixed dose in people with Type 1 Diabetes, run by John Hunter Children's Hospital at 5 sites in Australia.
Trial summary
In pediatric patients with type 1 diabetes using subcutaneous injections; a randomised controlled trial comparing the effects of fixed carbohydrate exchanges and insulin doses to the use of variable size meals and insulin doses determined with a bolus insulin calculation card. Read more about this study
- Who is it for?
- Ages 11 to 18 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- ezy-BICC dose calculation card and Fixed dose
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 5 sitesAustralia
- Study dates
- Mar 2008to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 11 - 18 years old
- Currently using indvidual subcutaneous injections (not CSII)
Who cannot join
- HbA1c > 9.5%
- Serious illness
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Australia5 sites, 5 recruiting
- Recruiting
Mater Children's Hospital
Brisbane, Queensland
Mark Harris, MD
Bridgid Knight
- Recruiting
Royal Children's Hospital
Brisbane, Queensland
Sarah MacMahon, MD
- Recruiting
Gosford District Hospital
Gosford, New South Wales, 2915
Monique Stone, MD
- Recruiting
John Hunter Children's Hospital
Newcastle, New South Wales, 2305
Donald Anderson, MBBS FRACP, +61 2 49855634, donald.anderson@hnehealth.nsw.gov.au
Liz Nunn, BHSc, 61 2 49213753, liz.nunn@hnehealth.nsw.gov.au
- Recruiting
Sydney Children's Hospital
Sydney, New South Wales
Charles Verge, MD
About this study
In pediatric patients with type 1 diabetes using subcutaneous injections; a randomised controlled trial comparing the effects of fixed carbohydrate exchanges and insulin doses to the use of variable size meals and insulin doses determined with a bolus insulin calculation card.
- Conditions
- Type 1 Diabetes
- Being tested
- ezy-BICC dose calculation card, Fixed dose
- Keywords
- Type 1 Diabetes, Youth, Insulin dose
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ezy-BICC dose calculation cardDevice
small laminated table lists the dose of insulin to administer based on BGL and carbohydrate to be consumed - individualised for each study subject
Fixed doseOther
Approach where study subject is prescribed a set amount of carbohydrate to eat each meal and set dose of rapid acting insulin. Minor modifications may be made if the measured BGL is out of target
| Study group | Role | What they receive |
|---|---|---|
| Fixed dose | Active comparator | Fixed meal size and fixed aspart insulin dose except for minor changes based on measured blood glucose. Detemir basal insulin. Receives: Other: Fixed dose |
| ezy-BICC dose calculation card | Experimental | variable meal size with variable aspart insulin dose determined with use of individualised dose calculation card. Detemir basal insulin. Receives: Device: ezy-BICC dose calculation card |
What is being measured
The primary outcome is the main question the study is designed to answer.
24 hours BGL > 8.3mmol/l (CGMS)
Measured: 3 months
Secondary outcomes (1)
HbA1c
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2008 (estimated)
- Study startMar 2008
- Primary completionOct 2010 (estimated)
- Study completionJan 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- John Hunter Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Royal North Shore Hospital, Sydney Children's Hospitals Network, Royal Children's Hospital, Lady Cilento Children's Hospital, Brisbane, NovoNordisk Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00748137
- Sponsor's protocol ID
- 06/04/26/5.01
- Status last verified
- Aug 2009
- First submitted
- 5 Sep 2008
- Last updated
- 8 Feb 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bolus Insulin Card Calculator Randomised Controlled Study
- ClinicalTrials.gov ID
- NCT00748137
- Acronym / sponsor ID
- 06/04/26/5.01
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 Diabetes, Youth, Insulin dose
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- John Hunter Children's HospitalUniversity, hospital or other
- Collaborators
- Royal North Shore Hospital, Sydney Children's Hospitals Network, Royal Children's Hospital, Lady Cilento Children's Hospital, Brisbane, NovoNordisk Pharmaceuticals
- Study start
- Mar 2008
- Primary completion
- Oct 2010 (estimated)
- Study completion
- Jan 2011 (estimated)
- First posted
- 8 Sep 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In pediatric patients with type 1 diabetes using subcutaneous injections; a randomised controlled trial comparing the effects of fixed carbohydrate exchanges and insulin doses to the use of variable size meals and insulin doses determined with a bolus insulin calculation card.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fixed dose | Active comparator | Other: Fixed doseFixed meal size and fixed aspart insulin dose except for minor changes based on measured blood glucose. Detemir basal insulin. |
| ezy-BICC dose calculation card | Experimental | Device: ezy-BICC dose calculation cardvariable meal size with variable aspart insulin dose determined with use of individualised dose calculation card. Detemir basal insulin. |
Who may qualify
- Ages
- 11 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age 11 - 18 years old
- Currently using indvidual subcutaneous injections (not CSII)
Key exclusion criteria (2 listed)
- HbA1c > 9.5%
- Serious illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ezy-BICC dose calculation cardsmall laminated table lists the dose of insulin to administer based on BGL and carbohydrate to be consumed - individualised for each study subject | Device | ezy-BICC dose calculation card |
| Fixed doseApproach where study subject is prescribed a set amount of carbohydrate to eat each meal and set dose of rapid acting insulin. Minor modifications may be made if the measured BGL is out of target | Other | Fixed dose |
Primary outcome
24 hours BGL > 8.3mmol/l (CGMS)
Time frame: 3 months
1 secondary outcome
HbA1c
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2010.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ezy-BICC dose calculation card and Fixed dose in people with Type 1 Diabetes, run by John Hunter Children's Hospital at 5 sites in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Feb 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Donald Anderson, FRACP (61-2-49855634, donald.anderson@hnehealth.nsw.gov.au), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
24 hours BGL > 8.3mmol/l (CGMS) (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Feb 2010.