Diabetes Mellitus, Type 1Phase 4NCT00462371
Comparison Between Insulin Pump Treatment and Multiple Daily Insulin Injections in Diabetic Type 1 Children
A Phase 4 study testing Insulin pump (CSII) in people with Diabetes Mellitus, Type 1 and Child, run by Erasmus Medical Center at 1 site in Netherlands.
Trial summary
Comparison between insulin pump treatment and multiple daily insulin injections in 38 children with type 1 diabetes4-16 years old. Outcome metabolic control, quality of life, impact of disease and cost effectiveness. We hypothesised that insulin pump treatment would give a better metabolic control and quality of life. Read more about this study
- Who is it for?
- Ages 4 to 16 years
- Conditions the study is for
- Diabetes Mellitus, Type 1, Child
- What is being tested?
- Insulin pump (CSII)
- Type of treatment
- Medical device
- How many people
- 38 participants
- Where
- 1 siteNetherlands
- Study dates
- Jan 2002to Feb 2004
- Phase
- Phase 4
- 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 4 to 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Type 1 diabetes,
- Diagnosed by the presence of IA-2,
- GAD-65 or islet cell cytoplasmatic auto antibodies,
- Daily insulin adminstration or 1 year of longer,
- Random C-peptide <200 pMol,
- Hba1c>8.0% and/or a history of repeated symptomatic hypoglycaemias,
- Attending regular school
Who cannot join
- Clinical manifest chronic complications,
- Pregnancy,
- Co-morbidity,
- Mental retardation,
- Psychiatric treatment or symptoms in child or parent,
- Insufficient Dutch language capabilities and absence of telephone at home
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
ErasmusMC/Sophia´s children´s Hospital
Rotterdam, 3015 GJ
About this study
Official title: Open-Label, Randomised Trial Comparing Efficacy of Continuous Subcutaneous Insulin Infusion(CSII) and Multiple Daily Insulin Injections (MDII) in Improving Glycemic Control and Quality of Life in Poorly Regulated Type 1 Diabetic Children.
Comparison between insulin pump treatment and multiple daily insulin injections in 38 children with type 1 diabetes4-16 years old. Outcome metabolic control, quality of life, impact of disease and cost effectiveness.
We hypothesised that insulin pump treatment would give a better metabolic control and quality of life.
Read the detailed description
The current standard of insulin treatment in type 1 diabetes is multiple daily insulin injection therapy (MDII). In the seventies, continuous subcutaneous insulin infusion (CSII) was introduced. CSII has been gaining popularity, perhaps because of technical advances resulting in improved patient comfort. In children five randomised studies(1-5) were completed to compare MDII and CSII. No data were gained about quality of life and impact of disease.
In our trial we focussed on quality of life next to metabolic control.
The trial was an open-labelled,randomised trial. Both efficacy and safety data were collected. The trial started with a 14 weeks run in phase, during all patients started MDII.In the following randomisation phase patients were randomised to continue MDII or to CSII.This phase lasted 14 weeks.In the phase thereafter all patients used CSII for 14 weeks. The trial was concluded by a 14 weeks allocated patient preference phase.
Patients were type 1 diabetic children 4-16 years old with poor metabolic control.hypothesis: better metabolic control in CSII, better quality of life in CSII.
- Conditions
- Diabetes Mellitus, Type 1, Child
- Being tested
- Insulin pump (CSII)
- Keywords
- quality of life, child diabetes mellitus type 1, Continuous subcutaneous insulin infusion(CSII), metabolic control
- 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.
Insulin pump (CSII)Device
What is being measured
The primary outcome is the main question the study is designed to answer.
metabolic control
quality of life
Secondary outcomes (4)
cost effectiveness
surrogate markers for late complications
adverse events
impact of disease
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2007 (estimated)
- Study startJan 2002
- Study completionFeb 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 38 participants
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health
- Investigators
- roos Nuboer, MD, Principal investigator, Erasmus Medical CenterJan Bruining, MD, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00462371
- Sponsor's protocol ID
- ASB21004821
- Status last verified
- Apr 2007
- First submitted
- 18 Apr 2007
- Last updated
- 19 Apr 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fox LA, Buckloh LM, Smith SD, Wysocki T, Mauras N. A randomized controlled trial of insulin pump therapy in young children with type 1 diabetes. Diabetes Care. 2005 Jun;28(6):1277-81. doi: 10.2337/diacare.28.6.1277.
PubMed 15920039Wilson DM, Buckingham BA, Kunselman EL, Sullivan MM, Paguntalan HU, Gitelman SE. A two-center randomized controlled feasibility trial of insulin pump therapy in young children with diabetes. Diabetes Care. 2005 Jan;28(1):15-9. doi: 10.2337/diacare.28.1.15.
PubMed 15616227Doyle EA, Weinzimer SA, Steffen AT, Ahern JA, Vincent M, Tamborlane WV. A randomized, prospective trial comparing the efficacy of continuous subcutaneous insulin infusion with multiple daily injections using insulin glargine. Diabetes Care. 2004 Jul;27(7):1554-8. doi: 10.2337/diacare.27.7.1554.
PubMed 15220227Weintrob N, Benzaquen H, Galatzer A, Shalitin S, Lazar L, Fayman G, Lilos P, Dickerman Z, Phillip M. Comparison of continuous subcutaneous insulin infusion and multiple daily injection regimens in children with type 1 diabetes: a randomized open crossover trial. Pediatrics. 2003 Sep;112(3 Pt 1):559-64. doi: 10.1542/peds.112.3.559.
PubMed 12949284DiMeglio LA, Pottorff TM, Boyd SR, France L, Fineberg N, Eugster EA. A randomized, controlled study of insulin pump therapy in diabetic preschoolers. J Pediatr. 2004 Sep;145(3):380-4. doi: 10.1016/j.jpeds.2004.06.022.
PubMed 15343195
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Randomised Trial Comparing Efficacy of Continuous Subcutaneous Insulin Infusion(CSII) and Multiple Daily Insulin Injections (MDII) in Improving Glycemic Control and Quality of Life in Poorly Regulated Type 1 Diabetic Children.
- ClinicalTrials.gov ID
- NCT00462371
- Acronym / sponsor ID
- ASB21004821
- Conditions
- Diabetes Mellitus, Type 1, Child
- Keywords
- quality of life, child diabetes mellitus type 1, Continuous subcutaneous insulin infusion(CSII), metabolic control
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Ministry of Health
- Study start
- Jan 2002
- Study completion
- Feb 2004 (actual)
- First posted
- 19 Apr 2007 (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.
Comparison between insulin pump treatment and multiple daily insulin injections in 38 children with type 1 diabetes4-16 years old. Outcome metabolic control, quality of life, impact of disease and cost effectiveness.
We hypothesised that insulin pump treatment would give a better metabolic control and quality of life.
Detailed description
The current standard of insulin treatment in type 1 diabetes is multiple daily insulin injection therapy (MDII). In the seventies, continuous subcutaneous insulin infusion (CSII) was introduced. CSII has been gaining popularity, perhaps because of technical advances resulting in improved patient comfort. In children five randomised studies(1-5) were completed to compare MDII and CSII. No data were gained about quality of life and impact of disease.
In our trial we focussed on quality of life next to metabolic control.
The trial was an open-labelled,randomised trial. Both efficacy and safety data were collected. The trial started with a 14 weeks run in phase, during all patients started MDII.In the following randomisation phase patients were randomised to continue MDII or to CSII.This phase lasted 14 weeks.In the phase thereafter all patients used CSII for 14 weeks. The trial was concluded by a 14 weeks allocated patient preference phase.
Patients were type 1 diabetic children 4-16 years old with poor metabolic control.hypothesis: better metabolic control in CSII, better quality of life in CSII.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 4 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- Type 1 diabetes,
- Diagnosed by the presence of IA-2,
- GAD-65 or islet cell cytoplasmatic auto antibodies,
- Daily insulin adminstration or 1 year of longer,
- Random C-peptide <200 pMol,
Key exclusion criteria (6 listed)
- Clinical manifest chronic complications,
- Pregnancy,
- Co-morbidity,
- Mental retardation,
- Psychiatric treatment or symptoms in child or parent,
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 |
|---|---|---|
| Insulin pump (CSII) | Device | – |
Primary outcome
metabolic control
quality of life
4 secondary outcomes
cost effectiveness
surrogate markers for late complications
adverse events
impact of disease
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 19 Apr 2007.
- Background: PubMed 15920039Fox LA, Buckloh LM, Smith SD, Wysocki T, Mauras N. A randomized controlled trial of insulin pump therapy in young children with type 1 diabetes. Diabetes Care. 2005 Jun;28(6):1277-81. doi: 10.2337/diacare.28.6.1277.
- Background: PubMed 15616227Wilson DM, Buckingham BA, Kunselman EL, Sullivan MM, Paguntalan HU, Gitelman SE. A two-center randomized controlled feasibility trial of insulin pump therapy in young children with diabetes. Diabetes Care. 2005 Jan;28(1):15-9. doi: 10.2337/diacare.28.1.15.
- Background: PubMed 15220227Doyle EA, Weinzimer SA, Steffen AT, Ahern JA, Vincent M, Tamborlane WV. A randomized, prospective trial comparing the efficacy of continuous subcutaneous insulin infusion with multiple daily injections using insulin glargine. Diabetes Care. 2004 Jul;27(7):1554-8. doi: 10.2337/diacare.27.7.1554.
- Background: PubMed 12949284Weintrob N, Benzaquen H, Galatzer A, Shalitin S, Lazar L, Fayman G, Lilos P, Dickerman Z, Phillip M. Comparison of continuous subcutaneous insulin infusion and multiple daily injection regimens in children with type 1 diabetes: a randomized open crossover trial. Pediatrics. 2003 Sep;112(3 Pt 1):559-64. doi: 10.1542/peds.112.3.559.
- Background: PubMed 15343195DiMeglio LA, Pottorff TM, Boyd SR, France L, Fineberg N, Eugster EA. A randomized, controlled study of insulin pump therapy in diabetic preschoolers. J Pediatr. 2004 Sep;145(3):380-4. doi: 10.1016/j.jpeds.2004.06.022.
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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.
roos Nuboer, MD principal investigator
Erasmus Medical Center
Jan Bruining, MD principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Insulin pump (CSII) in people with Diabetes Mellitus, Type 1 and Child, run by Erasmus Medical Center at 1 site in Netherlands.
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 7 inclusion and 6 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 19 Apr 2007. 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 Netherlands. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
metabolic control. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00462371, which also lists 5 linked publications.
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 19 Apr 2007.