Type 1 Diabetes MellitusNCT01555788
DiaPort Closed-Loop Artificial Pancreas
A study testing Artificial Pancreas for DiaPort system with Zone-MPC algorithm in people with Type 1 Diabetes Mellitus, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The primary purpose of this pilot study is to test an artificial pancreas system which uses the intra-peritoneal (IP) route for insulin delivery in type 1 diabetic patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- Artificial Pancreas for DiaPort system with Zone-MPC algorithm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- Feb 2012to Mar 2013
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient must be aged between 18 (inclusive) and 65 years old
- Patient must have been clinically diagnosed with Type 1 diabetes mellitus for at least one year
- Patient must have been identified as presenting an indication for the DiaPort® system, i.e. showing poor glucose control under Sc insulin delivery as shown by a sustained HbA1C level > 8% and/or high blood glucose variability including recurrent hypoglycemic events. Patient will be eligible for the study because he/she will have a DiaPort implanted.
- Patient must demonstrate proper mental status and cognition for the study
- Patient must be affiliated or beneficiary of a social medical insurance
- Patient has signed informed consent form prior to study entry
Who cannot join
- Unwilling to perform repeated glucose checks, consume standardized meals, and/or take insulin as instructed
- Evidence of cardiovascular event during the previous 6 months, non stabilized retinopathy, or clinically significant screening laboratory abnormalities
- Pregnancy, breast feeding, or intention of becoming pregnant
- Medical condition requiring use of an acetaminophen-containing medication that cannot be withheld for the study admissions.
- Patient is actively enrolled in another clinical trial or was part of study within 30 days or whose annual study income is over 4 500€
- Persons deprived of freedom, adults protected by law or vulnerable persons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Closed Loop Artificial Pancreas Using Intraperitoneal (IP) Insulin Via DiaPort®
The primary purpose of this pilot study is to test an artificial pancreas system which uses the intra-peritoneal (IP) route for insulin delivery in type 1 diabetic patients.
Read the detailed description
During this study, the investigators would like to evaluate the intra-peritoneal insulin delivery as a potential breakthrough method for delivering insulin within the artificial pancreas system.
The intent is to exploit the rapid action achieved by IP insulin to compensate for meals and for management of the basal insulin needs. Patients will come for two closed-loop admissions of 24 hours. The first closed-loop will be performed using subcutaneous route, whereas the second one will be performed using the intra-peritoneale route.
- Conditions
- Type 1 Diabetes Mellitus
- Being tested
- Artificial Pancreas for DiaPort system with Zone-MPC algorithm
- Keywords
- type 1 diabetes,, diaport,, artificial pancreas,, zone mpc algorithm,, ap system,, intraperitoneal insulin
- 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.
Artificial Pancreas for DiaPort system with Zone-MPC algorithmDevice
Artificial pancreas system uses the intraperitoneal route to deliver insulin (through DiaPort) in type 1 diabetic patients treated by basal-bolus insulin and external pumps.
| Study group | Role | What they receive |
|---|---|---|
| Type 1 diabetic population | Experimental | The only one arm (type 1 diabetic patients treated by basal-bolus insulin and external pumps) of this study will test an artificial pancreas system that uses the intraperitoneal route to deliver insulin (through DiaPort). Receives: Device: Artificial Pancreas for DiaPort system with Zone-MPC algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time spent with blood glucose between 3.9 and 8.0 mmol/L (79 - 144 mg/dl)
Percentage of time spent with blood glucose between 3.9 and 8.0 mmol/L (79 - 144 mg/dl):
- in the basal or late postprandial period
- in the early postprandial period (first 4 hours). All analyses will be done by using the YSI blood glucose measurements unless otherwise noted.
Measured: in the post prandial period (8 first hours after meal) during the in-clinic closed-loop 24-hour study period
Secondary outcomes (3)
Mean and standard deviation blood glucose
All analyses will include a comparison of the results in the Intraperitoneal versus Subcutaneous study days.
Measured: For the early postprandial period (first 4 hours after meal) and for the non-postprandial periods (from 8 hours after meal until next meal)
Percentage of time spent in hypoglycemia with blood glucose <3.3mmol/l (60 mg/dl)
All analyses will include a comparison of the results in the Intraperitoneal versus Subcutaneous study days.
Measured: during the 2 hospitalisations period when loop is closed (for a total of 24 hours)
Percentage of time spent in hyperglycemia
- Percentage of time spent in hyperglycemia with blood glucose >10 mmol/l (180 mg/dl) in the early postprandial period
- and Percentage of time spent in hyperglycemia>8mmol/l (144 mg/dl) in the basal or late postprandial period All analyses will include a comparison of the results in the Intraperitoneal versus Subcutaneous study days
Measured: in the early postprandial period (first 4 hours after meal) and in the basal or late postprandial period (from 8 hours after meal until next meal)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionMar 2013
- Study completionMar 2013
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.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eric ER RENARD, MD, PU-PH, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01555788
- Sponsor's protocol ID
- 8829
- Other IDs
- ID-RCB : 2011-A001212-39
- Status last verified
- Dec 2014
- First submitted
- 28 Feb 2012
- Last updated
- 20 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closed Loop Artificial Pancreas Using Intraperitoneal (IP) Insulin Via DiaPort®
- ClinicalTrials.gov ID
- NCT01555788
- Acronym / sponsor ID
- 8829
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- type 1 diabetes,, diaport,, artificial pancreas,, zone mpc algorithm,, ap system,, intraperitoneal insulin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 15 Mar 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 primary purpose of this pilot study is to test an artificial pancreas system which uses the intra-peritoneal (IP) route for insulin delivery in type 1 diabetic patients.
Detailed description
During this study, the investigators would like to evaluate the intra-peritoneal insulin delivery as a potential breakthrough method for delivering insulin within the artificial pancreas system.
The intent is to exploit the rapid action achieved by IP insulin to compensate for meals and for management of the basal insulin needs. Patients will come for two closed-loop admissions of 24 hours. The first closed-loop will be performed using subcutaneous route, whereas the second one will be performed using the intra-peritoneale route.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Type 1 diabetic population | Experimental | Device: Artificial Pancreas for DiaPort system with Zone-MPC algorithmThe only one arm (type 1 diabetic patients treated by basal-bolus insulin and external pumps) of this study will test an artificial pancreas system that uses the intraperitoneal route to deliver insulin (through DiaPort). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient must be aged between 18 (inclusive) and 65 years old
- Patient must have been clinically diagnosed with Type 1 diabetes mellitus for at least one year
- Patient must have been identified as presenting an indication for the DiaPort® system, i.e. showing poor glucose control under Sc insulin delivery as shown by a sustained HbA1C level > 8% and/or high blood glucose variability including recurrent hypoglycemic events. Patient will be eligible for the study because he/she will have a DiaPort implanted.
- Patient must demonstrate proper mental status and cognition for the study
- Patient must be affiliated or beneficiary of a social medical insurance
Key exclusion criteria (6 listed)
- Unwilling to perform repeated glucose checks, consume standardized meals, and/or take insulin as instructed
- Evidence of cardiovascular event during the previous 6 months, non stabilized retinopathy, or clinically significant screening laboratory abnormalities
- Pregnancy, breast feeding, or intention of becoming pregnant
- Medical condition requiring use of an acetaminophen-containing medication that cannot be withheld for the study admissions.
- Patient is actively enrolled in another clinical trial or was part of study within 30 days or whose annual study income is over 4 500€
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 |
|---|---|---|
| Artificial Pancreas for DiaPort system with Zone-MPC algorithmArtificial pancreas system uses the intraperitoneal route to deliver insulin (through DiaPort) in type 1 diabetic patients treated by basal-bolus insulin and external pumps. | Device | Type 1 diabetic population |
Primary outcome
Percentage of time spent with blood glucose between 3.9 and 8.0 mmol/L (79 - 144 mg/dl)
Time frame: in the post prandial period (8 first hours after meal) during the in-clinic closed-loop 24-hour study period
Percentage of time spent with blood glucose between 3.9 and 8.0 mmol/L (79 - 144 mg/dl): * in the basal or late postprandial period * in the early postprandial period (first 4 hours). All analyses will be done by using the YSI blood glucose measurements unless otherwise noted.
3 secondary outcomes
Mean and standard deviation blood glucose
Time frame: For the early postprandial period (first 4 hours after meal) and for the non-postprandial periods (from 8 hours after meal until next meal)
Percentage of time spent in hypoglycemia with blood glucose <3.3mmol/l (60 mg/dl)
Time frame: during the 2 hospitalisations period when loop is closed (for a total of 24 hours)
Percentage of time spent in hyperglycemia
Time frame: in the early postprandial period (first 4 hours after meal) and in the basal or late postprandial period (from 8 hours after meal until next meal)
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 20 Oct 2021.
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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.
Eric ER RENARD, MD, PU-PH principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Artificial Pancreas for DiaPort system with Zone-MPC algorithm in people with Type 1 Diabetes Mellitus, run by University Hospital, Montpellier 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 6 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 20 Oct 2021. 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?
Percentage of time spent with blood glucose between 3.9 and 8.0 mmol/L (79 - 144 mg/dl) (time frame: in the post prandial period (8 first hours after meal) during the in-clinic closed-loop 24-hour study period). 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 20 Oct 2021.