Type 1 DiabetesNCT01614496
Rule-Based Closed Loop System for Type 1 Diabetes Control
A study testing Algorithm for insulin administration in people with Type 1 Diabetes, run by Corporacion Parc Tauli at 1 site in Spain.
Trial summary
The aim of the study is to assess the efficacy and safety of a Rule-based Closed Loop system, using subcutaneous way, for the overnight and prandial glucose control in type 1 diabetic subjects. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Algorithm for insulin administration
- How many people
- Not given
- Where
- 1 siteSpain
- Study dates
- Start not givento not given
- 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 18 to 65 years
- All sexes
- Adult, Older adult
Who may be able to join
- Type 1 Diabetes
- Insulin pump treatment
- Undetectable C-Peptide
Who cannot join
- Autonomous system neuropathy
Trial locations and contacts
1 site in 1 country.
Spain1 site
Endocrinology and Nutrition Department. Corporació Sanitària i Universitària Parc Taulí
Sabadell, Barcelona, 08208
About this study
The aim of the study is to assess the efficacy and safety of a Rule-based Closed Loop system, using subcutaneous way, for the overnight and prandial glucose control in type 1 diabetic subjects. Ten subjects will be enrolled and they will participate in a cross-over study with a control night, using their usual insulin pump pattern, and with a experimental night, being controlled for the closed loop system. Each night includes the overnight control and prandial control of the breakfast.
The system proposes an insulin dose every 5 minutes according with the value of glucose displayed by the continuous glucose monitoring system.
- Conditions
- Type 1 Diabetes
- Being tested
- Algorithm for insulin administration
- 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.
Algorithm for insulin administrationOther
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent with glucose in the target range
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2012 (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
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01614496
- Sponsor's protocol ID
- PS09/01255
- Status last verified
- Jun 2013
- First submitted
- 7 Jun 2012
- Last updated
- 24 Sep 2013
- Results posted
- No
Publications
Capel I, Rigla M, Garcia-Saez G, Rodriguez-Herrero A, Pons B, Subias D, Garcia-Garcia F, Gallach M, Aguilar M, Perez-Gandia C, Gomez EJ, Caixas A, Hernando ME. Artificial pancreas using a personalized rule-based controller achieves overnight normoglycemia in patients with type 1 diabetes. Diabetes Technol Ther. 2014 Mar;16(3):172-9. doi: 10.1089/dia.2013.0229. Epub 2013 Oct 23.
PubMed 24152323
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rule-Based Closed Loop System for Type 1 Diabetes Control
- ClinicalTrials.gov ID
- NCT01614496
- Acronym / sponsor ID
- PS09/01255
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- First posted
- 8 Jun 2012 (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 aim of the study is to assess the efficacy and safety of a Rule-based Closed Loop system, using subcutaneous way, for the overnight and prandial glucose control in type 1 diabetic subjects. Ten subjects will be enrolled and they will participate in a cross-over study with a control night, using their usual insulin pump pattern, and with a experimental night, being controlled for the closed loop system. Each night includes the overnight control and prandial control of the breakfast.
The system proposes an insulin dose every 5 minutes according with the value of glucose displayed by the continuous glucose monitoring system.
Study design
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Type 1 Diabetes
- Insulin pump treatment
- Undetectable C-Peptide
Key exclusion criteria (1 listed)
- Autonomous system neuropathy
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 |
|---|---|---|
| Algorithm for insulin administration | Other | – |
Primary outcome
Time spent with glucose in the target range
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 24 Sep 2013.
- Derived from this study: PubMed 24152323Capel I, Rigla M, Garcia-Saez G, Rodriguez-Herrero A, Pons B, Subias D, Garcia-Garcia F, Gallach M, Aguilar M, Perez-Gandia C, Gomez EJ, Caixas A, Hernando ME. Artificial pancreas using a personalized rule-based controller achieves overnight normoglycemia in patients with type 1 diabetes. Diabetes Technol Ther. 2014 Mar;16(3):172-9. doi: 10.1089/dia.2013.0229. Epub 2013 Oct 23.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Algorithm for insulin administration in people with Type 1 Diabetes, run by Corporacion Parc Tauli at 1 site in Spain.
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 3 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 24 Sep 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 Spain. 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 with glucose in the target range. 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 NCT01614496, 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 24 Sep 2013.