Type 1 Diabetes MellitusNCT02099409
Safety and Efficacy of Overnight Closed Loop in Children With Type 1Diabetes Mellitus in Luxembourg
A study testing FLORENCED2 in people with Type 1 Diabetes Mellitus, run by Centre Hospitalier du Luxembourg at 2 sites in Luxembourg.
Trial summary
The purpose of this study is to validate current algorithms and evaluate safety and efficacy of overnight closed loop insulin delivery (FlorenceD2 system) in children with type 1 diabetes between 6 - 12 years of age in Luxembourg . Read more about this study
- Who is it for?
- Ages 6 to 12 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- FLORENCED2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesLuxembourg
- Study dates
- Jan 2014to Aug 2014
- 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 6 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Between 6 - ≤12 years
- With type 1 diabetes for 6 months or more and
- Pump user for at least 6 months.
- HbAc1 should be <11 %.
- No medication or physical or psychological disease should be present, which could interfere with the study.
Who cannot join
- -None
Trial locations and contacts
2 sites in 1 country.
Luxembourg2 sites
DECCP Clinique Pédiatrique de Luxembourg/CHL
Luxembourg, 1210
DECCP Pediatric Clinic , CHLuxembourg
Luxembourg, 1210
About this study
Official title: Open Label Single Center Randomized Cross Over Study to Validate Current Algorithms and Evaluate Safety and Efficacy of Closed Loop Insulin Delivery (FlorenceD2 System) in Children With Type 1 Diabetes Between 6 - 12 Years of Age
The purpose of this study is to validate current algorithms and evaluate safety and efficacy of overnight closed loop insulin delivery (FlorenceD2 system) in children with type 1 diabetes between 6 - 12 years of age in Luxembourg .
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- FLORENCED2
- Keywords
- Type 1 diabetes mellitus, children, closed loop, cross over, overnight, FLORENCED2, DANA Diabecare R pump, FreeStyle Navigator II, Dexcom G4
- 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.
FLORENCED2Device
FLORENCED2 device ensures the closed loop between Freestyle Navigator II and the DANA DIABECARE R
| Study group | Role | What they receive |
|---|---|---|
| Starting with FLORENCED2 followed by open loop | Experimental | Start 2 Overnight periods with closed loop through FLORENCED2 Device , followed by 2 overnight periods with open loop. Receives: Device: FLORENCED2 |
| Start open loop followed by FLORENCED2 | Experimental | Start with 2 overnight periods with open loop , followed by 2 overnight with closed loop FLORENCED2 Receives: Device: FLORENCED2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent in normal glucose range ( mg/dl)
Glucose will be measured with a Continuous glucose monitoring device
Measured: At least 5 hours between 7 pm and 7 am
Secondary outcomes (4)
glucose variability ( excursions in mg/dl)
Continuous Glucose Monitoring device
Measured: 7 pm - 7 am
Time spent in low glucose range (< 60 mg/dl)
Continuous Glucose Monitoring
Measured: 7 pm till 7 am
time spent in low glucose range (<70 mg/dl)
continuous glucose monitoring
Measured: 7 pm till 7 am
time spent in high glucose range (>180mg/dl)
continuous glucose monitoring
Measured: 7 pm - 7 am
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionAug 2014
- Study completionAug 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 Diabetes MellitusStudies 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier du Luxembourg
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cambridge
- Responsible party
- Principal investigator, Carine de Beaufort, Centre Hospitalier du Luxembourg
- Investigators
- Carine deBeaufort, MD PhD, Principal investigator, Centre Hospitalier du LuxembourgRoman Hovorka, Professor, Principal investigator, University of CambridgeGosia Wilinska, PhD, Principal investigator, University of CambridgeUlrike Schierloh, MD, Principal investigator, Centre Hospitalier du Luxembourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02099409
- Sponsor's protocol ID
- SPIDLUX 4
- Status last verified
- Sep 2014
- First submitted
- 26 Mar 2014
- Last updated
- 16 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label Single Center Randomized Cross Over Study to Validate Current Algorithms and Evaluate Safety and Efficacy of Closed Loop Insulin Delivery (FlorenceD2 System) in Children With Type 1 Diabetes Between 6 - 12 Years of Age
- ClinicalTrials.gov ID
- NCT02099409
- Acronym / sponsor ID
- SPIDLUX 4
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 diabetes mellitus, children, closed loop, cross over, overnight, FLORENCED2, DANA Diabecare R pump, FreeStyle Navigator II
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Centre Hospitalier du LuxembourgUniversity, hospital or other
- Collaborators
- University of Cambridge
- Study start
- Jan 2014
- Primary completion
- Aug 2014 (actual)
- Study completion
- Aug 2014 (actual)
- First posted
- 28 Mar 2014 (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 validate current algorithms and evaluate safety and efficacy of overnight closed loop insulin delivery (FlorenceD2 system) in children with type 1 diabetes between 6 - 12 years of age in Luxembourg .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Starting with FLORENCED2 followed by open loop | Experimental | Device: FLORENCED2Start 2 Overnight periods with closed loop through FLORENCED2 Device , followed by 2 overnight periods with open loop. |
| Start open loop followed by FLORENCED2 | Experimental | Device: FLORENCED2Start with 2 overnight periods with open loop , followed by 2 overnight with closed loop FLORENCED2 |
Who may qualify
- Ages
- 6 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Between 6 - ≤12 years
- With type 1 diabetes for 6 months or more and
- Pump user for at least 6 months.
- HbAc1 should be <11 %.
- No medication or physical or psychological disease should be present, which could interfere with the study.
Key exclusion criteria (1 listed)
- -None
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 |
|---|---|---|
| FLORENCED2FLORENCED2 device ensures the closed loop between Freestyle Navigator II and the DANA DIABECARE R | Device | Start open loop followed by FLORENCED2, Starting with FLORENCED2 followed by open loop |
Primary outcome
Time spent in normal glucose range ( mg/dl)
Time frame: At least 5 hours between 7 pm and 7 am
Glucose will be measured with a Continuous glucose monitoring device
4 secondary outcomes
glucose variability ( excursions in mg/dl)
Time frame: 7 pm - 7 am
Time spent in low glucose range (< 60 mg/dl)
Time frame: 7 pm till 7 am
time spent in low glucose range (<70 mg/dl)
Time frame: 7 pm till 7 am
time spent in high glucose range (>180mg/dl)
Time frame: 7 pm - 7 am
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 16 Sep 2014.
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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.
Carine deBeaufort, MD PhD principal investigator
Centre Hospitalier du Luxembourg
Roman Hovorka, Professor principal investigator
University of Cambridge
Gosia Wilinska, PhD principal investigator
University of Cambridge
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FLORENCED2 in people with Type 1 Diabetes Mellitus, run by Centre Hospitalier du Luxembourg at 2 sites in Luxembourg.
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 1 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 16 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Luxembourg. 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?
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?
Time spent in normal glucose range ( mg/dl) (time frame: At least 5 hours between 7 pm and 7 am). 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 16 Sep 2014.