Diabetes Mellitus, Type 1Phase 2NCT00146484
A Study of Two Versus Three Daily Injections in Children and Adolescents With Newly Diagnosed Type 1 Diabetes
A Phase 2 study testing Twice Daily versus Three Times Daily Insulin Injections in people with Diabetes Mellitus, Type 1, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
Trial summary
The optimal insulin regimen for children and adolescents with newly diagnosed type 1 diabetes remains unknown. The purpose of this study is to determine whether a split evening injection regimen (insulin injections before breakfast, supper and bedtime) leads to better glucose control and quality of life than twice… Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Twice Daily versus Three Times Daily Insulin Injections
- Type of treatment
- Injection or infusion
- How many people
- 100 participants
- Where
- 1 siteCanada
- Study dates
- Apr 1996to Jan 2001
- Phase
- Phase 2
- 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 Up to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- New onset type 1 diabetes
- Less than 48 hours since first insulin injection
- Child and/or parent able to read and write English
- Family intends to continue treatment at our institution for the next two years
- Informed consent from adolescents greater than 16 years of age, or if less than 16 years, informed consent from the parent/guardian with assent from the child.
Who cannot join
- Chronic medical conditions other than treated hypothyroidism or mild asthma
- Concerns of the diabetes team regarding future treatment adherence making twice daily insulin preferable to the split evening injection regimen (e.g., cognitive impairment, severe family dysfunction).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Controlled Trial of Two Versus Three Daily Insulin Injections in Children and Adolescents With New Onset Type 1 Diabetes Mellitus
The optimal insulin regimen for children and adolescents with newly diagnosed type 1 diabetes remains unknown. The purpose of this study is to determine whether a split evening injection regimen (insulin injections before breakfast, supper and bedtime) leads to better glucose control and quality of life than twice daily insulin in children and adolescents with new onset diabetes.
Read the detailed description
The optimal insulin regimen for children and adolescents with newly diagnosed type 1 diabetes remains unknown. No published studies have examined the effectiveness of a split evening (three times daily) injection regimen in this group of patients. Indeed, because the first few years of diabetes management are the easiest (due to a "honeymoon" period characterised by residual insulin secretion), the potential for any benefit from more intensive management (i.e., three daily injections) may be small during this period. In addition, the intensity of the initial insulin regimen may be an important determinant of quality of life, family functioning, and subsequent compliance with diabetes regimens. A randomized controlled trial has been designed to test the hypothesis that a split evening injection regimen leads to better glycemic control and quality of life than twice daily insulin in children and adolescents with new onset diabetes.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Twice Daily versus Three Times Daily Insulin Injections
- Keywords
- Diabetes Mellitus, Type 1, Child, Adolescent, Disease Management, Newly Diagnosed, Hemoglobin A, Glycosylated
- 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.
Twice Daily versus Three Times Daily Insulin InjectionsDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
* Hemoglobin A1c over the first 24 months of diabetes
Secondary outcomes (5)
* Frequency of hypoglycemia (mild and severe) over the first 24 months of diabetes
* Frequency of morning hyperglycemia over the first 24 months of diabetes
* Residual c-peptide at two years post diagnosis (stimulated c-peptide post Sustacal challenge)
* Diabetes Quality of Life (DQOLY) over the first 24 months of diabetes
* Family Functioning (Family Environment Scale)over the first 24 months of diabetes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
- Study startApr 1996
- Study completionJan 2001
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 1Studies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 100 participants
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Eastern Ontario
- Sponsor type
- University, hospital or other
- Investigators
- Margaret L Lawson, MD, Principal investigator, Children's Hospital of Eastern Ontario
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00146484
- Sponsor's protocol ID
- CHEO RI cc9993
- Status last verified
- Sep 2005
- First submitted
- 6 Sep 2005
- Last updated
- 7 Sep 2005
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Sep 2005. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Two Versus Three Daily Insulin Injections in Children and Adolescents With New Onset Type 1 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT00146484
- Acronym / sponsor ID
- CHEO RI cc9993
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- Diabetes Mellitus, Type 1, Child, Adolescent, Disease Management, Newly Diagnosed, Hemoglobin A, Glycosylated
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants
- Lead sponsor
- Children's Hospital of Eastern OntarioUniversity, hospital or other
- Study start
- Apr 1996
- Study completion
- Jan 2001
- First posted
- 7 Sep 2005 (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.
The optimal insulin regimen for children and adolescents with newly diagnosed type 1 diabetes remains unknown. The purpose of this study is to determine whether a split evening injection regimen (insulin injections before breakfast, supper and bedtime) leads to better glucose control and quality of life than twice daily insulin in children and adolescents with new onset diabetes.
Detailed description
The optimal insulin regimen for children and adolescents with newly diagnosed type 1 diabetes remains unknown. No published studies have examined the effectiveness of a split evening (three times daily) injection regimen in this group of patients. Indeed, because the first few years of diabetes management are the easiest (due to a "honeymoon" period characterised by residual insulin secretion), the potential for any benefit from more intensive management (i.e., three daily injections) may be small during this period. In addition, the intensity of the initial insulin regimen may be an important determinant of quality of life, family functioning, and subsequent compliance with diabetes regimens. A randomized controlled trial has been designed to test the hypothesis that a split evening injection regimen leads to better glycemic control and quality of life than twice daily insulin in children and adolescents with new onset diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- New onset type 1 diabetes
- Less than 48 hours since first insulin injection
- Child and/or parent able to read and write English
- Family intends to continue treatment at our institution for the next two years
- Informed consent from adolescents greater than 16 years of age, or if less than 16 years, informed consent from the parent/guardian with assent from the child.
Key exclusion criteria (2 listed)
- Chronic medical conditions other than treated hypothyroidism or mild asthma
- Concerns of the diabetes team regarding future treatment adherence making twice daily insulin preferable to the split evening injection regimen (e.g., cognitive impairment, severe family dysfunction).
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 |
|---|---|---|
| Twice Daily versus Three Times Daily Insulin Injections | Drug | – |
Primary outcome
* Hemoglobin A1c over the first 24 months of diabetes
5 secondary outcomes
* Frequency of hypoglycemia (mild and severe) over the first 24 months of diabetes
* Frequency of morning hyperglycemia over the first 24 months of diabetes
* Residual c-peptide at two years post diagnosis (stimulated c-peptide post Sustacal challenge)
* Diabetes Quality of Life (DQOLY) over the first 24 months of diabetes
* Family Functioning (Family Environment Scale)over the first 24 months of diabetes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Sep 2005.
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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.
Margaret L Lawson, MD principal investigator
Children's Hospital of Eastern Ontario
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Twice Daily versus Three Times Daily Insulin Injections in people with Diabetes Mellitus, Type 1, run by Children's Hospital of Eastern Ontario at 1 site in Canada.
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 5 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: finished, as of the sponsor's last update on 7 Sep 2005. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
* Hemoglobin A1c over the first 24 months of diabetes. 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 7 Sep 2005.