Type1 Diabetes MellitusSPIDIMAN2NCT03300934
Adolescence and Diabetes:Can an Automated Closed Loop System Improve Control ?
A study of Type1 Diabetes Mellitus, run by Centre Hospitalier du Luxembourg at 1 site in Luxembourg.
Trial summary
This study evaluates the use of the FD2 automated closed loop insulin administration in Adolescents with a poor metabolic control . All youth will be treated in a random order by their usual pump treatment or an Automated system and we will evaluate whether this has an impact on metabolic control and sleep Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Type1 Diabetes Mellitus
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteLuxembourg
- Study dates
- 1 Jul 2017to 19 Jul 2018
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 12- 18 years Type 1 diabetes according to WHO/ISPAD , for at least 1 year CSII treatment for at least 6 month HbA1c ≥ 8,0%, for more than 6 months Informed consent of the patient and parents
Who cannot join
- Non-type 1 diabetes mellitus including those secondary to chronic disease Any other physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator.
- Current treatment with drugs known to have significant interference with glucose metabolism, such as systemic corticosteroids, as judged by the investigator Known or suspected allergy against insulin Recurrent incidents of severe hypoglycaemia as defined by ISPAD guidelines during the previous 12 months.
- More than one episode of diabetic ketoacidosis (DKA) as defined by ISPAD in preceding 12 months
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adolescence and Diabetes: Can an Automated Closed Loop System Improve Control ?
This study evaluates the use of the FD2 automated closed loop insulin administration in Adolescents with a poor metabolic control . All youth will be treated in a random order by their usual pump treatment or an Automated system and we will evaluate whether this has an impact on metabolic control and sleep
Read the detailed description
Achievement of a good metabolic control is very important for all persons with diabetes . In adolescence many changes occur , physically , socially and psychologically .This may influence the metabolic control . This study will evaluate whether the automated closed-loop will facilitate and improve the management of diabetes in youth with a poor metabolic control.
It is a single-centre, randomised, two-period crossover study to assess the efficacy /safety and acceptability of the automated closed-loop glucose control (CL) day and night, over 28 days in comparison with continuous subcutaneous insulin infusion (CSII) in the home setting in poorly controlled type 1 diabetes adolescents.
- Conditions
- Type1 Diabetes Mellitus
- Being tested
- closed loop glucose control system
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
closed loop glucose control systemDevice
Cross over between Closed loop glucose system with DANA pump, Navigator II CGM and Cambridge AP algorithm FD2A, versus usual CSII pump treatment
| Study group | Role | What they receive |
|---|---|---|
| closed loop glucose control system | Experimental | Closed loop glucose control system Receives: Device: closed loop glucose control system |
| CSII Pump treatment | No intervention | CSII Pump treatment without the integrated algorithm and glucose sensor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent in glucose target (%) (3.9 - 10 mmol/l)
Continuous blinded glucose monitoring during the study period with and without the automated Closed loop on a between arm comparison.
Measured: 4 week treatment arms
Secondary outcomes (9)
Time spent below glucose target (%) (<3.0mmol/l and < 2,5 mmol/l)
Continuous blinded glucose monitoring during the study period with and without automated closed loop (%)
Measured: 4 week treatment arms
Time spent above glucose target (%) (> 10 mmol/l)
Continuous blinded glucose monitoring during the study period with and without automated closed loop (%)
Measured: 4 week treatment arms
Severe hypoglycaemic events
ISPAD Definition of severe hypoglycemia
Measured: 4 week treatment arms
Severe Diabetes ketoacidosis
ISPAD definition of severe DKA
Measured: 4 week treatment arms
Use of the automated closed loop system (% time)
% time , the system is used
Measured: 4 week treatment arm
Use of the CGM during closed loop
% time , the system is used
Measured: 4 week treatment arm
Quality of life perception in adolescents
Questionnaire based
Measured: 4 week treatment periods
Family Responsibility perception
Questionnaire based : Family responsibility scale
Measured: 4 week treatment periods
User experience after the 4 week treatment
questionnaire based
Measured: 4 week intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Oct 2017
- Study start1 Jul 2017
- Primary completion19 Jul 2018
- Study completion19 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type1 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
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier du Luxembourg
- Sponsor type
- University, hospital or other
- Collaborators
- University of Cambridge, Luxembourg Institute of Health
- Responsible party
- Principal investigator, Carine de Beaufort, Centre Hospitalier du Luxembourg
- Investigators
- Carine de Beaufort, MD PhD, Principal investigator, Centre Hospitalier du Luxembourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03300934
- Sponsor's protocol ID
- Spidiman
- Acronym
- SPIDIMAN2
- Status last verified
- Jul 2018
- First submitted
- 29 Sep 2017
- Last updated
- 31 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adolescence and Diabetes: Can an Automated Closed Loop System Improve Control ?
- ClinicalTrials.gov ID
- NCT03300934
- Acronym / sponsor ID
- SPIDIMAN2 / Spidiman
- Conditions
- Type1 Diabetes Mellitus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Centre Hospitalier du LuxembourgUniversity, hospital or other
- Collaborators
- University of Cambridge, Luxembourg Institute of Health
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 19 Jul 2018 (actual)
- Study completion
- 19 Jul 2018 (actual)
- First posted
- 4 Oct 2017 (actual)
- 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.
This study evaluates the use of the FD2 automated closed loop insulin administration in Adolescents with a poor metabolic control . All youth will be treated in a random order by their usual pump treatment or an Automated system and we will evaluate whether this has an impact on metabolic control and sleep
Detailed description
Achievement of a good metabolic control is very important for all persons with diabetes . In adolescence many changes occur , physically , socially and psychologically .This may influence the metabolic control . This study will evaluate whether the automated closed-loop will facilitate and improve the management of diabetes in youth with a poor metabolic control.
It is a single-centre, randomised, two-period crossover study to assess the efficacy /safety and acceptability of the automated closed-loop glucose control (CL) day and night, over 28 days in comparison with continuous subcutaneous insulin infusion (CSII) in the home setting in poorly controlled type 1 diabetes adolescents.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| closed loop glucose control system | Experimental | Device: closed loop glucose control systemClosed loop glucose control system |
| CSII Pump treatment | No intervention | –CSII Pump treatment without the integrated algorithm and glucose sensor |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (1 listed)
- 12- 18 years Type 1 diabetes according to WHO/ISPAD , for at least 1 year CSII treatment for at least 6 month HbA1c ≥ 8,0%, for more than 6 months Informed consent of the patient and parents
Key exclusion criteria (4 listed)
- Non-type 1 diabetes mellitus including those secondary to chronic disease Any other physical or psychological disease or condition likely to interfere with the normal conduct of the study and interpretation of the study results as judged by the investigator.
- Current treatment with drugs known to have significant interference with glucose metabolism, such as systemic corticosteroids, as judged by the investigator Known or suspected allergy against insulin Recurrent incidents of severe hypoglycaemia as defined by ISPAD guidelines during the previous 12 months.
- More than one episode of diabetic ketoacidosis (DKA) as defined by ISPAD in preceding 12 months
- -
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 |
|---|---|---|
| closed loop glucose control systemCross over between Closed loop glucose system with DANA pump, Navigator II CGM and Cambridge AP algorithm FD2A, versus usual CSII pump treatment | Device | closed loop glucose control system |
Primary outcome
Time spent in glucose target (%) (3.9 - 10 mmol/l)
Time frame: 4 week treatment arms
Continuous blinded glucose monitoring during the study period with and without the automated Closed loop on a between arm comparison.
9 secondary outcomes
Time spent below glucose target (%) (<3.0mmol/l and < 2,5 mmol/l)
Time frame: 4 week treatment arms
Time spent above glucose target (%) (> 10 mmol/l)
Time frame: 4 week treatment arms
Severe hypoglycaemic events
Time frame: 4 week treatment arms
Severe Diabetes ketoacidosis
Time frame: 4 week treatment arms
Use of the automated closed loop system (% time)
Time frame: 4 week treatment arm
Use of the CGM during closed loop
Time frame: 4 week treatment arm
Quality of life perception in adolescents
Time frame: 4 week treatment periods
Family Responsibility perception
Time frame: 4 week treatment periods
User experience after the 4 week treatment
Time frame: 4 week intervention
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 31 Jul 2018.
- Individual participant dataSharing planned: No
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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 de Beaufort, MD PhD principal investigator
Centre Hospitalier du Luxembourg
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Type1 Diabetes Mellitus, run by Centre Hospitalier du Luxembourg at 1 site 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 1 inclusion and 4 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 31 Jul 2018. 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 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 glucose target (%) (3.9 - 10 mmol/l) (time frame: 4 week treatment arms). 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 31 Jul 2018.