Type 1 DiabetesPPANCT02061488
Assessment of a New Closed-loop Algorithm in Type 1 Diabetes (Saddle Point Model Predictive Control : SP-MPC) (PPA)
A study testing open-loop night and closed-loop night in people with Type 1 Diabetes, run by Rennes University Hospital at 1 site in France.
Trial summary
The purpose of the study is to assess a new closed-loop algorithm in type 1 diabetes (Saddle Point Model Predictive Control : SP-MPC) Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- open-loop night and closed-loop night
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Mar 2014to Jul 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with type 1 diabetes (C peptide negative) :
- 18 to 70 year old,
- with type 1 diabetes for more than 3 years,
- treated by insulin pump for more than 3 months,
- with previous CGM holter allowing preliminary settting of some of the SP-MPC parameters
- able to provide written informed consent.
Who cannot join
- pregnancy or breastfeeding,
- severe non stabilized diabetic retinopathy,
- cardiovascular event in the previous 6 months,
- infectious diseases with recent fever,
- anemia (hemoglobin < 11g/l),
- HbA1c > 10%,
Show all 10Show fewer
- Current or recent (less than 4 weeks) oral or injectable corticosteroid treatment,
- creatinine clearance <40ml/mn,
- chronic alcoholism (weekly consumption of alcohol > 280g for men and > 140g for women),
- adults legally protected (under judicial protection, guardianship, or supervision), persons deprived of their liberty
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective, Monocentric, Crossover Randomized Trial, to Assess a New Closed-loop Algorithm in Type 1 Diabetes (Saddle Point Model Predictive Control : SP-MPC)
The purpose of the study is to assess a new closed-loop algorithm in type 1 diabetes (Saddle Point Model Predictive Control : SP-MPC)
Read the detailed description
Ten patients will be assessed during a closed-loop night and an open-loop night in random order.
The primary objective is to assess the ability of SP-MPC controler to maintain euglycemia and avoid hypoglycaemia during the night, compared to open loop in type 1 diabetic patients treated by insulin pump.
- Conditions
- Type 1 Diabetes
- Being tested
- open-loop night, closed-loop night
- Keywords
- Artificial pancreas, closed loop glucose control, model predictive control
- 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.
open-loop nightOther
During the open-loop night the patient is using his insulin pump as usual
closed-loop nightOther
During the closed-loop night glucose values measured by the sensor are collected every 15 minutes. The data are entered into the SP-MPC controler that calculate the insulin dose to be delivered. A diabetologist validates the insulin dose before the infusion (manually bolus infusion)
| Study group | Role | What they receive |
|---|---|---|
| open-loop night | Active comparator | Not described Receives: Other: open-loop night |
| closed-loop night | Experimental | Not described Receives: Other: closed-loop night |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of time spent in target range (glycemia between 70 and 145 mg/dl) and in hypoglycemia (glycemia <70 mg/dl), during the night (11 PM to 8 AM)
Assessment of the ability of SP-MPC controler to maintain euglycemia and avoid hypoglycaemia during the night, compared to open loop in type 1 diabetic patients treated by insulin pump
Measured: 6 weeks
Secondary outcomes (7)
Assessment of time spent above 70 mg/dl, between 70-145 or 145-180 mg/dl and above 180 mg/dl (interstitial glucose) in the late post prandial period (9 to 11 PM) and during the night (11 PM to 8 AM)
Assessment of hypoglycemia and hyperglycemia cases, average glycemic balance, glycemic variability, insulin doses
Measured: 6 weeks
Assessment of hypoglycemia occurrence during the night
Measured: 6 weeks
Assessment of area under the curves (70-180mg/dl) during the night
Measured: 6 weeks
Assessment of Low Blood Glucose Index (LBGI), High Blood Glucose Index (HBGI) and CONGA Index
Measured: 6 weeks
Assessment of insulin doses delivered between 9 PM and 8 AM
Measured: 6 weeks
Assessment of number of controller propositions rejected for security reasons
Measured: 6 weeks
Assessment of glucose values during the night (glycemia and interstitial glucose values)
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionJul 2014
- Study completionJul 2014
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
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Isabelle Guilhem, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02061488
- Sponsor's protocol ID
- 2013-A01604-41
- Other IDs
- 35RC13_8806_PPA
- Acronym
- PPA
- Status last verified
- May 2023
- First submitted
- 11 Feb 2014
- Last updated
- 24 May 2023
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Guilhem I, Penet M, Paillard A, Carpentier M, Esvant A, Lefebvre MA, Poirier JY. Manual Closed-Loop Insulin Delivery Using a Saddle Point Model Predictive Control Algorithm: Results of a Crossover Randomized Overnight Study. J Diabetes Sci Technol. 2017 Sep;11(5):1007-1014. doi: 10.1177/1932296817717503. Epub 2017 Jul 5.
PubMed 28677416
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Monocentric, Crossover Randomized Trial, to Assess a New Closed-loop Algorithm in Type 1 Diabetes (Saddle Point Model Predictive Control : SP-MPC)
- ClinicalTrials.gov ID
- NCT02061488
- Acronym / sponsor ID
- PPA / 2013-A01604-41
- Conditions
- Type 1 Diabetes
- Keywords
- Artificial pancreas, closed loop glucose control, model predictive control
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Jul 2014 (actual)
- Study completion
- Jul 2014 (actual)
- First posted
- 12 Feb 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 the study is to assess a new closed-loop algorithm in type 1 diabetes (Saddle Point Model Predictive Control : SP-MPC)
Detailed description
Ten patients will be assessed during a closed-loop night and an open-loop night in random order.
The primary objective is to assess the ability of SP-MPC controler to maintain euglycemia and avoid hypoglycaemia during the night, compared to open loop in type 1 diabetic patients treated by insulin pump.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| open-loop night | Active comparator | Other: open-loop night |
| closed-loop night | Experimental | Other: closed-loop night |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patients with type 1 diabetes (C peptide negative) :
- 18 to 70 year old,
- with type 1 diabetes for more than 3 years,
- treated by insulin pump for more than 3 months,
- with previous CGM holter allowing preliminary settting of some of the SP-MPC parameters
Key exclusion criteria (10 listed)
- pregnancy or breastfeeding,
- severe non stabilized diabetic retinopathy,
- cardiovascular event in the previous 6 months,
- infectious diseases with recent fever,
- anemia (hemoglobin < 11g/l),
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 |
|---|---|---|
| open-loop nightDuring the open-loop night the patient is using his insulin pump as usual | Other | open-loop night |
| closed-loop nightDuring the closed-loop night glucose values measured by the sensor are collected every 15 minutes. The data are entered into the SP-MPC controler that calculate the insulin dose to be delivered. A diabetologist validates the insulin dose before the infusion (manually bolus infusion) | Other | closed-loop night |
Primary outcome
Assessment of time spent in target range (glycemia between 70 and 145 mg/dl) and in hypoglycemia (glycemia <70 mg/dl), during the night (11 PM to 8 AM)
Time frame: 6 weeks
Assessment of the ability of SP-MPC controler to maintain euglycemia and avoid hypoglycaemia during the night, compared to open loop in type 1 diabetic patients treated by insulin pump
7 secondary outcomes
Assessment of time spent above 70 mg/dl, between 70-145 or 145-180 mg/dl and above 180 mg/dl (interstitial glucose) in the late post prandial period (9 to 11 PM) and during the night (11 PM to 8 AM)
Time frame: 6 weeks
Assessment of hypoglycemia occurrence during the night
Time frame: 6 weeks
Assessment of area under the curves (70-180mg/dl) during the night
Time frame: 6 weeks
Assessment of Low Blood Glucose Index (LBGI), High Blood Glucose Index (HBGI) and CONGA Index
Time frame: 6 weeks
Assessment of insulin doses delivered between 9 PM and 8 AM
Time frame: 6 weeks
Assessment of number of controller propositions rejected for security reasons
Time frame: 6 weeks
Assessment of glucose values during the night (glycemia and interstitial glucose values)
Time frame: 6 weeks
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 May 2023.
- Results publication: PubMed 28677416Guilhem I, Penet M, Paillard A, Carpentier M, Esvant A, Lefebvre MA, Poirier JY. Manual Closed-Loop Insulin Delivery Using a Saddle Point Model Predictive Control Algorithm: Results of a Crossover Randomized Overnight Study. J Diabetes Sci Technol. 2017 Sep;11(5):1007-1014. doi: 10.1177/1932296817717503. Epub 2017 Jul 5.
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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.
Isabelle Guilhem principal investigator
Rennes University 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 open-loop night and closed-loop night in people with Type 1 Diabetes, run by Rennes University Hospital at 1 site in France.
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 6 inclusion and 10 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 May 2023. 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 France. 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?
Assessment of time spent in target range (glycemia between 70 and 145 mg/dl) and in hypoglycemia (glycemia <70 mg/dl), during the night (11 PM to 8 AM) (time frame: 6 weeks). 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 NCT02061488, 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 May 2023.