Type 1 DiabetesNCT01840358
Hypoglycemia at Initiation of Pump Therapy in Children With Type 1 Diabetes
A study testing Observation of hypoglycemias frequency 3 days before and after pump initiation in people with Type 1 Diabetes, run by St. Justine's Hospital at 1 site in Canada.
Trial summary
The purpose of this study is to determine if patients have more hypoglycemic episodes the first 3 days following pump start compared to their usual number of hypoglycemias with our actual pump initiation protocol. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Observation of hypoglycemias frequency 3 days before and after pump initiation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2013to Dec 2013
- 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 Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients with type 1 diabetes with follow-up at the CHU Sainte-Justine
- Patient about to start insulin pump therapy at the CHU Sainte-Justine
- Last HbA1c between 7.2 and 9.7%
- Informed and signed consent
Who cannot join
- Type 1 diabetes diagnosed less than 1 year ago WITH total daily dose of insulin < 0.5U/kg/day
- Home of the patient at more than 50km of the CHU Sainte-Justine
- Refusal to consent
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
CHU Sainte-Justine
Montreal, Quebec, H3T 1C5
Patricia Olivier, MD, 514-345-4931 ext. 5486, patricia.olivier.hsj@ssss.gouv.qc.ca
Patricia Olivier, MD
About this study
Official title: Evaluation of the Frequency of Hypoglycemia at Initiation of Insulin Pump Therapy in Children With Type 1 Diabetes
The purpose of this study is to determine if patients have more hypoglycemic episodes the first 3 days following pump start compared to their usual number of hypoglycemias with our actual pump initiation protocol.
- Conditions
- Type 1 Diabetes
- Being tested
- Observation of hypoglycemias frequency 3 days before and after pump initiation
- Keywords
- Hypoglycemias, Insulin pump, Children
- 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.
Observation of hypoglycemias frequency 3 days before and after pump initiationOther
| Study group | Role | What they receive |
|---|---|---|
| Patients starting pump therapy | Other | Not described Receives: Other: Observation of hypoglycemias frequency 3 days before and after pump initiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of hypoglycemias
Frequency of hypoglycemias defined as blood sugars < 4.0mmol/l
Measured: 6 days
Secondary outcomes (1)
Frequency of hyperglycemias
Frequency of hyperglycemias defined as blood sugars > 17.0mmol/L
Measured: 6 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study startApr 2013
- Primary completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Justine's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Olivier, St. Justine's Hospital
- Investigators
- patricia Olivier, Md, Principal investigator, St. Justine's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840358
- Sponsor's protocol ID
- HSJ-3638
- Status last verified
- Apr 2013
- First submitted
- 22 Apr 2013
- Last updated
- 26 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Manousaki D, Deladoey J, Geoffroy L, Olivier P. Continuous Subcutaneous Insulin Infusion in Children: A Pilot Study Validating a Protocol to Avoid Hypoglycemia at Initiation. Front Endocrinol (Lausanne). 2017 Apr 24;8:84. doi: 10.3389/fendo.2017.00084. eCollection 2017.
PubMed 28484424
Study at a glance
From the registry record, last updated by the sponsor on 26 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Frequency of Hypoglycemia at Initiation of Insulin Pump Therapy in Children With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT01840358
- Acronym / sponsor ID
- HSJ-3638
- Conditions
- Type 1 Diabetes
- Keywords
- Hypoglycemias, Insulin pump, Children
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- St. Justine's HospitalUniversity, hospital or other
- Study start
- Apr 2013
- Primary completion
- Dec 2013 (estimated)
- First posted
- 25 Apr 2013 (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 purpose of this study is to determine if patients have more hypoglycemic episodes the first 3 days following pump start compared to their usual number of hypoglycemias with our actual pump initiation protocol.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients starting pump therapy | Other | Other: Observation of hypoglycemias frequency 3 days before and after pump initiation |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients with type 1 diabetes with follow-up at the CHU Sainte-Justine
- Patient about to start insulin pump therapy at the CHU Sainte-Justine
- Last HbA1c between 7.2 and 9.7%
- Informed and signed consent
Key exclusion criteria (3 listed)
- Type 1 diabetes diagnosed less than 1 year ago WITH total daily dose of insulin < 0.5U/kg/day
- Home of the patient at more than 50km of the CHU Sainte-Justine
- Refusal to consent
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 |
|---|---|---|
| Observation of hypoglycemias frequency 3 days before and after pump initiation | Other | Patients starting pump therapy |
Primary outcome
Frequency of hypoglycemias
Time frame: 6 days
Frequency of hypoglycemias defined as blood sugars < 4.0mmol/l
1 secondary outcome
Frequency of hyperglycemias
Time frame: 6 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Apr 2013.
- Derived from this study: PubMed 28484424Manousaki D, Deladoey J, Geoffroy L, Olivier P. Continuous Subcutaneous Insulin Infusion in Children: A Pilot Study Validating a Protocol to Avoid Hypoglycemia at Initiation. Front Endocrinol (Lausanne). 2017 Apr 24;8:84. doi: 10.3389/fendo.2017.00084. eCollection 2017.
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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.
patricia Olivier, Md principal investigator
St. Justine's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Observation of hypoglycemias frequency 3 days before and after pump initiation in people with Type 1 Diabetes, run by St. Justine's Hospital 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 4 inclusion and 3 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 26 Apr 2013. 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.
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 Patricia Olivier, MD (514-345-4931 ext. 5486, patricia.olivier.hsj@ssss.gouv.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of hypoglycemias (time frame: 6 days). 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 NCT01840358, which also lists 1 linked publication.
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 26 Apr 2013.