Secondary Pancreatic DiabetesIADIASPNCT06227650
Closed-loop Insulin Delivery Systems in Pancreatic Diabetes
An observational study of Secondary Pancreatic Diabetes, run by Centre Hospitalier Sud Francilien at 1 site in France.
Trial summary
The purpose of this study is to evaluate the metabolic and the safety outcomes in people living with pancreatic diabetes (pancreatitis or pancreatectomy-induced diabetes) and using a closed-loop insulin delivery systems ("artificial pancreas"). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Pancreatic Diabetes
- What is being tested?
- hybrid closed loop insulin delivery system
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteFrance
- Study dates
- 6 Feb 2024to 5 Apr 2024
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with secondary pancreatic diabetes and implementation of automated insulin therapy in BF
Who may be able to join
- Adult patient
- Presenting secondary pancreatic diabetes
- Treatment with insulin closed-loop delivery
Who cannot join
- Patient who objected to the use of data
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Closed-loop Insulin Delivery Systems ("Artificial Pancreas") in Patients With Pancreatitis or Pancreatectomy-induced Diabetes: an Observational Case Series
The purpose of this study is to evaluate the metabolic and the safety outcomes in people living with pancreatic diabetes (pancreatitis or pancreatectomy-induced diabetes) and using a closed-loop insulin delivery systems ("artificial pancreas").
Read the detailed description
Secondary pancreatic diabetes is an unstable diabetes, due to deficiency in B cells which produce insulin, alpha cells which produce glucagon, and exorcrine insufficiency. Patients with secondary pancreatic diabetes are exposed to high glycemic variability and severe hypoglycemic episodes. Hybrid closed loop treatment has shown efficacy and safety for patients with type 1 diabetes and has the potential to improve the control of secondary pancreatic diabetes but has rarely been studied in this particular indication.
A retrospective observational cohort study in patients will be contucted suffering from secondary pancreatic diabetes in whom this device was implemented in order to observe metabolic and safety outcomes compared to the period before they were treated with hybrid closed-loop system.
- Conditions
- Secondary Pancreatic Diabetes
- Being tested
- hybrid closed loop insulin delivery system
- Keywords
- Closed-loop insulin delivery systems, artificial pancreas, pancreatitis, pancreatectomy, secondary diabetes, continuous glucose monitoring
- Medical subject headings
- Pancreatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hybrid closed loop insulin delivery systemDevice
Patients with secondary pancreatic diabetes equipped with a hybrid closed loop insulin delivery device
| Study group | Role | What they receive |
|---|---|---|
| Group1 | Patients with secondary pancreatic diabetes equipped with a hybrid closed loop insulin delivery device Receives: Device: hybrid closed loop insulin delivery system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time spent in the target
Percentage of time spent in the target, between 70 and 180 mg/dl: 14 to 90 days before starting hybrid closed loop
Measured: at day 0
Percentage of time spent in the target
Percentage of time spent in the target, between 70 and 180 mg/dl the last 90 days available (T1) after starting hybrid closed loop
Measured: at day 90
Secondary outcomes (13)
Percentage of time spent
Percentage of time spent bellow 70 mg/dL (TBR for Time Bellow Range ) and Above 180 mg/dL (TAR for Time Above Range )
Measured: at day 0
Percentage of time spent
Percentage of time spent bellow 70 mg/dL (TBR for Time Bellow Range ) and Above 180 mg/dL (TAR for Time Above Range )
Measured: at day 90
Pourcentage of closed-loop mode use
Pourcentage of closed-loop mode use
Measured: at day 90
Hypoglycemia events (serveral hypoglycemia )
Number of serveral hypoglycemia events requiring hospitilisation and/or emergency
Measured: at day 0
Hypoglycemia events (serveral hypoglycemia )
Number of serveral hypoglycemia events requiring hospitilisation and/or emergency
Measured: at day 90
Hyperglycemia events
Number of hyperglycemia events requiring hospitalisation and /or emergency
Measured: at day 0
Hyperglycemia events
Number of hyperglycemia events requiring hospitalisation and /or emergency
Measured: at day 90
Glucose Management Indicator (GMI)
Glucose Management Indicator (GMI)
Measured: at day 0
Glucose Management Indicator (GMI)
Glucose Management Indicator (GMI)
Measured: at day 90
Coeffecient of variabilty of Glucose Management Indicator
Coeffecient of variabilty
Measured: at day 0
Coeffecient of variabilty of Glucose Management Indicator
Coeffecient of variabilty
Measured: at day 90
Microangiopathic events
Number of microangiopathic events (diabetic retinopathy ,diabetic nephropathy, diabetic neuropathy )
Measured: at day 0
Microangiopathic events
Number of microangiopathic events (diabetic retinopathy ,diabetic nephropathy, diabetic neuropathy )
Measured: at day 90
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start6 Feb 2024
- Primary completion5 Apr 2024
- Study completion5 Apr 2024
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 Secondary Pancreatic 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Sud Francilien
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Alfred PENFORNIS, PHD, Principal investigator, Centre Hospitalier Sud Francilien
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227650
- Sponsor's protocol ID
- 2023/0057
- Acronym
- IADIASP
- Status last verified
- Apr 2024
- First submitted
- 17 Jan 2024
- Last updated
- 8 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Touimer M, Charfi H, Sa Cunha A, Penfornis A, Amadou C. Closed-loop insulin delivery systems in patients with pancreatitis or pancreatectomy-induced diabetes: A case series. Diabetes Metab. 2024 Jul;50(4):101544. doi: 10.1016/j.diabet.2024.101544. Epub 2024 May 24.
PubMed 38788339
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Closed-loop Insulin Delivery Systems ("Artificial Pancreas") in Patients With Pancreatitis or Pancreatectomy-induced Diabetes: an Observational Case Series
- ClinicalTrials.gov ID
- NCT06227650
- Acronym / sponsor ID
- IADIASP / 2023/0057
- Conditions
- Secondary Pancreatic Diabetes
- Keywords
- Closed-loop insulin delivery systems, artificial pancreas, pancreatitis, pancreatectomy, secondary diabetes, continuous glucose monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Centre Hospitalier Sud FrancilienUniversity, hospital or other
- Study start
- 6 Feb 2024 (actual)
- Primary completion
- 5 Apr 2024 (actual)
- Study completion
- 5 Apr 2024 (actual)
- First posted
- 29 Jan 2024 (actual)
- 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 this study is to evaluate the metabolic and the safety outcomes in people living with pancreatic diabetes (pancreatitis or pancreatectomy-induced diabetes) and using a closed-loop insulin delivery systems ("artificial pancreas").
Detailed description
Secondary pancreatic diabetes is an unstable diabetes, due to deficiency in B cells which produce insulin, alpha cells which produce glucagon, and exorcrine insufficiency. Patients with secondary pancreatic diabetes are exposed to high glycemic variability and severe hypoglycemic episodes. Hybrid closed loop treatment has shown efficacy and safety for patients with type 1 diabetes and has the potential to improve the control of secondary pancreatic diabetes but has rarely been studied in this particular indication.
A retrospective observational cohort study in patients will be contucted suffering from secondary pancreatic diabetes in whom this device was implemented in order to observe metabolic and safety outcomes compared to the period before they were treated with hybrid closed-loop system.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group1 | – | Device: hybrid closed loop insulin delivery systemPatients with secondary pancreatic diabetes equipped with a hybrid closed loop insulin delivery device |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with secondary pancreatic diabetes and implementation of automated insulin therapy in BF
Key inclusion criteria (3 listed)
- Adult patient
- Presenting secondary pancreatic diabetes
- Treatment with insulin closed-loop delivery
Key exclusion criteria (1 listed)
- Patient who objected to the use of data
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 |
|---|---|---|
| hybrid closed loop insulin delivery systemPatients with secondary pancreatic diabetes equipped with a hybrid closed loop insulin delivery device | Device | Group1 |
Primary outcome
Percentage of time spent in the target
Time frame: at day 0
Percentage of time spent in the target, between 70 and 180 mg/dl: 14 to 90 days before starting hybrid closed loop
Percentage of time spent in the target
Time frame: at day 90
Percentage of time spent in the target, between 70 and 180 mg/dl the last 90 days available (T1) after starting hybrid closed loop
13 secondary outcomes
Percentage of time spent
Time frame: at day 0
Percentage of time spent
Time frame: at day 90
Pourcentage of closed-loop mode use
Time frame: at day 90
Hypoglycemia events (serveral hypoglycemia )
Time frame: at day 0
Hypoglycemia events (serveral hypoglycemia )
Time frame: at day 90
Hyperglycemia events
Time frame: at day 0
Hyperglycemia events
Time frame: at day 90
Glucose Management Indicator (GMI)
Time frame: at day 0
Glucose Management Indicator (GMI)
Time frame: at day 90
Coeffecient of variabilty of Glucose Management Indicator
Time frame: at day 0
Coeffecient of variabilty of Glucose Management Indicator
Time frame: at day 90
Microangiopathic events
Time frame: at day 0
Microangiopathic events
Time frame: at day 90
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 8 Apr 2024.
- Derived from this study: PubMed 38788339Touimer M, Charfi H, Sa Cunha A, Penfornis A, Amadou C. Closed-loop insulin delivery systems in patients with pancreatitis or pancreatectomy-induced diabetes: A case series. Diabetes Metab. 2024 Jul;50(4):101544. doi: 10.1016/j.diabet.2024.101544. Epub 2024 May 24.
- Individual participant dataSharing planned: No
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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.
Alfred PENFORNIS, PHD principal investigator
Centre Hospitalier Sud Francilien
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Secondary Pancreatic Diabetes, run by Centre Hospitalier Sud Francilien 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 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 8 Apr 2024. 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 in the target (time frame: at day 0). The study lists 2 primary outcomes in all. 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 NCT06227650, 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 8 Apr 2024.