Type 1 DiabetesIDCLTrainingNCT02892604
Study the Feasibility of Permanent Use of inControl for the Treatment of Type 1 Diabetes
A study of Type 1 Diabetes, run by University Hospital, Montpellier at 1 site in France.
Trial summary
A new version of the DiAs artificial pancreas (AP) system has been developed in view of wide scale outpatient trials. Denominated as inControl , it includes improved user interface and communication modules while closed-loop algorithms remain similar. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Type 1 Diabetes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteFrance
- Study dates
- 24 Nov 2015to 24 Jun 2017
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Type 1 diabetes mellitus since more than one year, treated by insulin since at least one year
- Treatment by insulin pump since at least 6 months
- Glycated hemoglobin (HbA1c) below 10.5% at inclusion visit
- For women of child bearing age, no current pregnancy and use of an efficient contraception during the whole research participation
- Agreement on no use of drugs or products used for reduction of blood glucose levels, such as metformin or GLP1 analogs, except if this therapy has been used for at least 3 months before study start
- Agreement on stopping closed-loop insulin delivery after acetaminophen use and 4 following hours
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- Agreement on suspending use of patient CGM device during the study period while study CGM will be used
- Access to the internet and a mobile phone network at home
- Agreement on following study procedures
- Affiliation to the French social security system or a similar healthcare coverage system
- Mandatory written informed consent
Who cannot join
- Need for chronic use of acetaminophen
- Start of use of drugs or products used for reduction of blood glucose levels, such as metformin or GLP1 analogs during the 3 months before inclusion
- Hemophilia or other coagulation disorders
- Psychological and/or cognitive troubles which may impair the appropriate following of study procedures
- Diabetic ketoacidosis during the last 6 months
- Acute cardiovascular event during the last 12 months
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- Severe hypoglycaemia with convulsions or loss of conscience during the last 12 months
- Use of a therapy with significant impact on glucose metabolism
- Cystic fibrosis
- Lack of nearby third-party assistance availability in case of troubles
- Malignant disease, except if considered as cured since at least 10 years
- Impaired kidney function (serum creatinin > 150 umol/L)
- Impaired liver status (ALAT or ASAT > 2-times upper normal limit)
- Active gastroparesis
- Acute adrenocortical event
- Alcohol or narcotics abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Evaluation Study of the Feasibility of a Permanent Use in Free-life of inControl Artificial Pancreas System for the Treatment of Type 1 Diabetes
A new version of the DiAs artificial pancreas (AP) system has been developed in view of wide scale outpatient trials. Denominated as inControl , it includes improved user interface and communication modules while closed-loop algorithms remain similar. During this pilot study, the investigators will evaluate this new version of AP for a two-week period during which the patients will use it for closed-loop insulin delivery 24/7 The main goal is train the clinical team with the new system and collect patient opinions on system acceptance from questionnaires. If this trial is conclusive, a randomized 6-month multicentre study including 240 patients will be initiated. A total of 5 patients will be included in this training study over a 4-week period.
- Conditions
- Type 1 Diabetes
- Being tested
- insulin pump to inControl AP platform
- Keywords
- Type 1 diabetes, artificial pancreas, closed-loop insulin infusion
- 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.
insulin pump to inControl AP platformDevice
Insulin from the pump is delivered according to the closed-loop algorithm fed by CGM data.
| Study group | Role | What they receive |
|---|---|---|
| insulin delivery driven by inControl | Experimental | Closed-loop insulin delivery using inControl AP system is assessed for two weeks, 24/7.
Connection of continuous glucose monitoring (CGM) system and insulin pump to inControl AP platform, all wireless and wearable, in free-life conditions Insulin from the pump is delivered according to the closed-loop algorithm fed by CGM data. Receives: Device: insulin pump to inControl AP platform |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent time of active insulin closed-loop delivery
Percent time while AP system is active permanently
Measured: 2 weeks
Secondary outcomes (1)
Percent time with blood glucose in target range
Percent time while blood glucose is kept in safe 70-180 mg/dl range
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Sep 2016 (estimated)
- Study start24 Nov 2015
- Primary completion24 Jun 2017
- Study completion24 Jun 2017
Why it stopped: not enough participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- MEDBIOMED, Montpellier, France, Jaeb Center for Health Research, University of Virginia
- Responsible party
- Sponsor
- Investigators
- Eric M RENARD, MD, PhD, Study director, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02892604
- Sponsor's protocol ID
- 9722
- Acronym
- IDCLTraining
- Status last verified
- Dec 2021
- First submitted
- 2 Sep 2016
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation Study of the Feasibility of a Permanent Use in Free-life of inControl Artificial Pancreas System for the Treatment of Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT02892604
- Acronym / sponsor ID
- IDCLTraining / 9722
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes, artificial pancreas, closed-loop insulin infusion
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: not enough participants
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- MEDBIOMED, Montpellier, France, Jaeb Center for Health Research, University of Virginia
- Study start
- 24 Nov 2015 (actual)
- Primary completion
- 24 Jun 2017 (actual)
- Study completion
- 24 Jun 2017 (actual)
- First posted
- 8 Sep 2016 (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.
A new version of the DiAs artificial pancreas (AP) system has been developed in view of wide scale outpatient trials. Denominated as inControl , it includes improved user interface and communication modules while closed-loop algorithms remain similar. During this pilot study, the investigators will evaluate this new version of AP for a two-week period during which the patients will use it for closed-loop insulin delivery 24/7 The main goal is train the clinical team with the new system and collect patient opinions on system acceptance from questionnaires. If this trial is conclusive, a randomized 6-month multicentre study including 240 patients will be initiated. A total of 5 patients will be included in this training study over a 4-week period.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| insulin delivery driven by inControl | Experimental | Device: insulin pump to inControl AP platformClosed-loop insulin delivery using inControl AP system is assessed for two weeks, 24/7. Connection of continuous glucose monitoring (CGM) system and insulin pump to inControl AP platform, all wireless and wearable, in free-life conditions Insulin from the pump is delivered according to the closed-loop algorithm fed by CGM data. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Type 1 diabetes mellitus since more than one year, treated by insulin since at least one year
- Treatment by insulin pump since at least 6 months
- Glycated hemoglobin (HbA1c) below 10.5% at inclusion visit
- For women of child bearing age, no current pregnancy and use of an efficient contraception during the whole research participation
- Agreement on no use of drugs or products used for reduction of blood glucose levels, such as metformin or GLP1 analogs, except if this therapy has been used for at least 3 months before study start
Key exclusion criteria (16 listed)
- Need for chronic use of acetaminophen
- Start of use of drugs or products used for reduction of blood glucose levels, such as metformin or GLP1 analogs during the 3 months before inclusion
- Hemophilia or other coagulation disorders
- Psychological and/or cognitive troubles which may impair the appropriate following of study procedures
- Diabetic ketoacidosis during the last 6 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 |
|---|---|---|
| insulin pump to inControl AP platformInsulin from the pump is delivered according to the closed-loop algorithm fed by CGM data. | Device | insulin delivery driven by inControl |
Primary outcome
Percent time of active insulin closed-loop delivery
Time frame: 2 weeks
Percent time while AP system is active permanently
1 secondary outcome
Percent time with blood glucose in target range
Time frame: 2 weeks
Results and safety
The study was stopped early (reason given: not enough participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2021.
- Individual participant dataSharing planned: Undecided
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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 M RENARD, MD, PhD study director
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 of Type 1 Diabetes, 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 11 inclusion and 16 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: stopped early, as of the sponsor's last update on 9 Dec 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 was stopped early (reason given: not enough participants). Results are not available in the source record.
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?
Percent time of active insulin closed-loop delivery (time frame: 2 weeks). 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 9 Dec 2021.