An interventional study of closed loop glucose control system in Type1 Diabetes Mellitus, sponsored by Centre Hospitalier du Luxembourg. Completed at 1 site in Luxembourg. Open to participants aged 12 Years to 18 Years. Per ClinicalTrials.gov, last updated 2018-07-31.
Sponsored by Centre Hospitalier du Luxembourg · Not applicable, Interventional, and Treatment
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Among 10 studies in Diabetes Mellitus, Type 1 with a site in Luxembourg — none open to participants now, none under way, none of them phase 3. Diabetes Mellitus, Type 1 · Luxembourg.
Among the 10 studies in Diabetes Mellitus, Type 1 with a site in Luxembourg, this one is one of 3 that started in 2017, is one of 7 with no phase, and was the 7th registered.
3,754 studies on the registry are indexed under Diabetes Mellitus, Type 1; 600 are open to participants now.
Browse Diabetes Mellitus, Type 1 studies →None of the 10 studies in Diabetes Mellitus, Type 1 with a site in Luxembourg is open now. The open studies under Diabetes Mellitus, Type 1, anywhere →
Of the 412 Diabetes Mellitus, Type 1 studies recruiting now, 128 (31%) set no upper age limit and 258 (63%) stop at 75 or younger; 185 take children under 18; 64 take healthy volunteers.
This study: 12 Years to 18 Years · all sexes · no healthy volunteers.
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10 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 3 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 16 is below the median of 40 across 2,820 interventional studies indexed under Diabetes Mellitus, Type 1.
Median enrollment 57 across the 8 interventional studies, 3,006 across the 2 observational. Of the 9 that completed or were terminated, 3 (33%) have results posted.
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2 of 10 have an industry lead sponsor. The 6 most frequent:
Centre Hospitalier du Luxembourg is the lead sponsor of 5 studies on the registry; none are open to participants now.
Centre Hospitalier du Luxembourg has 3 studies filed under Diabetes Mellitus, Type 1 — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 10 studies in Diabetes Mellitus, Type 1 with a site in Luxembourg, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
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
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
12- 18 years Type 1 diabetes according to WHO/ISPAD , for at least 1 year CSII treatment for at least 6 month ≥ 8,0%, for more than 6 months of the patient and parents
Exclusion Criteria:
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 , 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
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Closed loop glucose control system
Device: closed loop glucose control system
CSII Pump treatment without the integrated algorithm and glucose sensor
Cross over between Closed loop glucose system with DANA pump, Navigator II CGM and Cambridge AP algorithm FD2A, versus usual CSII pump treatment
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.
Time frame: 4 week treatment arms
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 (%)
Time frame: 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 (%)
Time frame: 4 week treatment arms
Severe hypoglycaemic events
ISPAD Definition of severe hypoglycemia
Time frame: 4 week treatment arms
Severe Diabetes ketoacidosis
ISPAD definition of severe DKA
Time frame: 4 week treatment arms
Use of the automated closed loop system (% time)
% time , the system is used
Time frame: 4 week treatment arm
Use of the CGM during closed loop
% time , the system is used
Time frame: 4 week treatment arm
Quality of life perception in adolescents
Questionnaire based
Time frame: 4 week treatment periods
Family Responsibility perception
Questionnaire based : Family responsibility scale
Time frame: 4 week treatment periods
User experience after the 4 week treatment
questionnaire based
Time frame: 4 week intervention
Plan to share: No
No publications or documents are linked to this record.
Ran from Jul 2017 to primary completion in Jul 2018, 12 months.
Of 845 non-industry interventional studies with no phase under Diabetes Mellitus, Type 1, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's 12 months is below that.
Counting every sponsor, half of 950 studies reached it within 18 months; a quarter within 9 and three quarters within 35.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Centre Hospitalier du Luxembourg