Chronic PancreatitisNCT01945138
Closed Loop Insulin Pump Therapy After Islet Auto-Transplantation
A study testing Closed Loop Insulin in people with Chronic Pancreatitis and Diabetes Mellitus, run by University of Minnesota at 1 site in United States.
Trial summary
The purpose of this study is to determine the effectiveness of closed loop insulin pump therapy to control blood sugar following total pancreatectomy and islet auto-transplantation (TPIAT). Read more about this study
- Who is it for?
- Ages 21 to 64 years
- Conditions the study is for
- Chronic Pancreatitis, Diabetes Mellitus
- What is being tested?
- Closed Loop Insulin
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Dec 2015
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 21 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients undergoing total pancreatectomy and islet auto-transplantation.
- Patients ages 21 to 64 years old
Who cannot join
- Preexisting diabetes
- Use of acetaminophen during study period, which interferes with CGM sensor function
- Any medical condition requiring corticosteroids
- Severe Psychiatric disease or developmental delays, that might interfere with the ability to provide informed consent
- Any other medical condition which in the opinion of the investigators impairs the person's ability to safely participate in the trial
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota
Minneapolis, Minnesota, 55454
About this study
Official title: Efficacy and Feasibility of Fully Automated Closed Loop Insulin Pump Therapy After Islet Auto-Transplantation
The purpose of this study is to determine the effectiveness of closed loop insulin pump therapy to control blood sugar following total pancreatectomy and islet auto-transplantation (TPIAT).
Read the detailed description
OBJECTIVES AND HYPOTHESES The main objective of this study is to determine if a closed loop insulin system can successfully achieve tighter blood sugar control than the current multiple daily injection regimen. The investigators hypothesize that the average blood glucose will be lower in the closed loop group than the control group, there will be less glucose variability in the closed loop group than the control group, and there will be less total time spent in hyperglycemia and hypoglycemia in the closed loop group than in the control group. The investigators also will investigate insulin requirements and islet function in the first 6 months post-transplant in the closed loop group The investigators hypothesize that the insulin requirements will be lower and the C-peptide levels higher in the closed loop group than in the control group.
- Conditions
- Chronic Pancreatitis, Diabetes Mellitus
- Being tested
- Closed Loop Insulin
- Keywords
- Total Pancreatectomy, Islet Auto-Transplantation, Closed Loop Insulin Pump
- Medical subject headings
- Pancreatitis, Chronic, Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Closed Loop InsulinDevice
Also called Medtronic ePID 2.0 system, Medtronic Paradigm REAL-Time Insulin Pump (MMT-722), Enlite Glucose Sensor (MMT-7008X), MiniLink REAL-Time Transmitter (MMT-7703XNA)
The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms).
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period. |
| Closed Loop Insulin | Experimental | Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period. Receives: Device: Closed Loop Insulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Study Period: Average Serum BG
Mean blood glucose value: a single report of the average of the analytical blood glucose values will be computed and compared between the pump and control groups.
Measured: 3 days of investigation period
Study Period: Serum BG Standard Deviation
Measure of glycemic variability. This is the standard deviation in all serum BG values for each individual patient.
Measured: 3 days of investigation period
Secondary outcomes (13)
Study Period: Continuous Glucose Monitor (CGM) BG Average
Continuous glucose monitoring sensor data: The CGM's in the pump and control groups will collect glucose readings continuously over a 72 hour period
Measured: continuously over the 72 hour investigational period
Study Period: Continuous Glucose Monitor Standard Deviation of BG
measure of glycemic variability by CGM. This is the standard deviation within each patient for all CGM glucose readings.
Measured: continuous over the 72 hour investigation period
Study Period: Percent Time BG in Range 70-140 mg/dL
Additional measure of glycemic variability, as reflected by CGM measures, % time in the range of 70-140 on CGM
Measured: continuous over the 72 hour investigation period
Study Period: CGM Area Under the Curve (AUC) With Glucose < 70 mg/dL
Calculated as the area under the curve on the CGM tracing that the glucose is under 70 mg/dL.
Measured: continuous over the 72 hour investigation period
Study Period: % of Time CGM BG <70 mg/dL
Measured: continuous over the 72 hour investigation period
Study Period: CGM AUC With Glucose> 140 mg/dL
Measured: continuous over the 72 hour investigation period
Study Period: % of Time CGM BG > 140 mg/dL
Measured: continuous over the 72 hour investigation period
Study Period: Morning C-peptide
A single C-peptide measurement collected daily x 3 days, collected at random (meaning not in a fasting state) each morning. Expressed as average for each patient.
Measured: Average of 3 day study period
Study Period: Daily Insulin Needs
Calculated as total daily dose of insulin.
Measured: Average of 3 day study period
Day 14 Follow-Up: Average Serum BG
Measured: Day 14 Follow-Up
Day 14 Follow-Up: C-Peptide
Measured: Day 14 Follow-Up:
Day 28 Follow-Up: Average Serum BG
Measured: Day 28 Follow-Up
Day 28 Follow-Up: C-Peptide
Measured: Day 28 Follow-Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2013 (estimated)
- Study startFeb 2014
- Primary completionJun 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic PancreatitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic MiniMed, Inc.
- Responsible party
- Sponsor
- Investigators
- Melena Bellin, MD, Principal investigator, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01945138
- Sponsor's protocol ID
- CLTPIAT2013
- Other IDs
- 21856
- Status last verified
- Jun 2017
- First submitted
- 19 Aug 2013
- Last updated
- 31 Jul 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Forlenza GP, Nathan BM, Moran AM, Dunn TB, Beilman GJ, Pruett TL, Bellin MD. Successful Application of Closed-Loop Artificial Pancreas Therapy After Islet Autotransplantation. Am J Transplant. 2016 Feb;16(2):527-34. doi: 10.1111/ajt.13539. Epub 2015 Nov 20.
PubMed 26588810
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Feasibility of Fully Automated Closed Loop Insulin Pump Therapy After Islet Auto-Transplantation
- ClinicalTrials.gov ID
- NCT01945138
- Acronym / sponsor ID
- CLTPIAT2013
- Conditions
- Chronic Pancreatitis, Diabetes Mellitus
- Keywords
- Total Pancreatectomy, Islet Auto-Transplantation, Closed Loop Insulin Pump
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Medtronic MiniMed, Inc.
- Study start
- Feb 2014
- Primary completion
- Jun 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 18 Sep 2013 (estimated)
- Results
- Posted 13 Jan 2016
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 determine the effectiveness of closed loop insulin pump therapy to control blood sugar following total pancreatectomy and islet auto-transplantation (TPIAT).
Detailed description
OBJECTIVES AND HYPOTHESES The main objective of this study is to determine if a closed loop insulin system can successfully achieve tighter blood sugar control than the current multiple daily injection regimen. The investigators hypothesize that the average blood glucose will be lower in the closed loop group than the control group, there will be less glucose variability in the closed loop group than the control group, and there will be less total time spent in hyperglycemia and hypoglycemia in the closed loop group than in the control group. The investigators also will investigate insulin requirements and islet function in the first 6 months post-transplant in the closed loop group The investigators hypothesize that the insulin requirements will be lower and the C-peptide levels higher in the closed loop group than in the control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period. |
| Closed Loop Insulin | Experimental | Device: Closed Loop InsulinClosed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period. |
Who may qualify
- Ages
- 21 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients undergoing total pancreatectomy and islet auto-transplantation.
- Patients ages 21 to 64 years old
Key exclusion criteria (5 listed)
- Preexisting diabetes
- Use of acetaminophen during study period, which interferes with CGM sensor function
- Any medical condition requiring corticosteroids
- Severe Psychiatric disease or developmental delays, that might interfere with the ability to provide informed consent
- Any other medical condition which in the opinion of the investigators impairs the person's ability to safely participate in the trial
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 |
|---|---|---|
| Closed Loop InsulinAlso: Medtronic ePID 2.0 system, Medtronic Paradigm REAL-Time Insulin Pump (MMT-722), Enlite Glucose Sensor (MMT-7008X), MiniLink REAL-Time Transmitter (MMT-7703XNA)The Closed Loop Insulin system is an automated insulin delivery system based on body blood glucose. It consists of an Insulin pump, continuous glucose monitor, and a control device (laptop with algorithms). | Device | Closed Loop Insulin |
Primary outcome
Study Period: Average Serum BG
Time frame: 3 days of investigation period
Mean blood glucose value: a single report of the average of the analytical blood glucose values will be computed and compared between the pump and control groups.
Study Period: Serum BG Standard Deviation
Time frame: 3 days of investigation period
Measure of glycemic variability. This is the standard deviation in all serum BG values for each individual patient.
13 secondary outcomes
Study Period: Continuous Glucose Monitor (CGM) BG Average
Time frame: continuously over the 72 hour investigational period
Study Period: Continuous Glucose Monitor Standard Deviation of BG
Time frame: continuous over the 72 hour investigation period
Study Period: Percent Time BG in Range 70-140 mg/dL
Time frame: continuous over the 72 hour investigation period
Study Period: CGM Area Under the Curve (AUC) With Glucose < 70 mg/dL
Time frame: continuous over the 72 hour investigation period
Study Period: % of Time CGM BG <70 mg/dL
Time frame: continuous over the 72 hour investigation period
Study Period: CGM AUC With Glucose> 140 mg/dL
Time frame: continuous over the 72 hour investigation period
Study Period: % of Time CGM BG > 140 mg/dL
Time frame: continuous over the 72 hour investigation period
Study Period: Morning C-peptide
Time frame: Average of 3 day study period
Study Period: Daily Insulin Needs
Time frame: Average of 3 day study period
Day 14 Follow-Up: Average Serum BG
Time frame: Day 14 Follow-Up
Day 14 Follow-Up: C-Peptide
Time frame: Day 14 Follow-Up:
Day 28 Follow-Up: Average Serum BG
Time frame: Day 28 Follow-Up
Day 28 Follow-Up: C-Peptide
Time frame: Day 28 Follow-Up
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 26588810Forlenza GP, Nathan BM, Moran AM, Dunn TB, Beilman GJ, Pruett TL, Bellin MD. Successful Application of Closed-Loop Artificial Pancreas Therapy After Islet Autotransplantation. Am J Transplant. 2016 Feb;16(2):527-34. doi: 10.1111/ajt.13539. Epub 2015 Nov 20.
Related trials for Chronic Pancreatitis
RecruitingPhase 1
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Food Effect of CBT-248 in Healthy Adult Participants
Chronic Pancreatitis
Not yet recruitingObservational study
AI-Assisted Differentiation of Autoimmune Pancreatitis and Pancreatic Cancer Using EUS: A Multicenter Ambispective Study
Autoimmune Pancreatitis, Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 3
Comparative Study to Evaluate Microbial Versus Porcine Pancreatic Enzyme Therapy in Chronic Pancreatitis
Pancreatitis, Chronic, Exocrine Pancreatic Insufficiency (EPI)
Active, not recruitingPhase 4
A Study Of Effect Of Secretin For In Injection (Chirostim) On Pancreatic Fluid Composition In Healthy Subjects
Exocrine Pancreatic Insufficiency, Chronic Pancreatitis
RecruitingPhase 1/2
Soy Tomato Juice to Improve Outcomes in Pancreatitis
Recurrent Acute Pancreatitis, Chronic Pancreatitis
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.
Melena Bellin, MD principal investigator
University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Closed Loop Insulin in people with Chronic Pancreatitis and Diabetes Mellitus, run by University of Minnesota at 1 site in United States.
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 2 inclusion and 5 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 31 Jul 2017. 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 United States. 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?
Yes. Results are posted in the registry (first posted 13 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Study Period: Average Serum BG (time frame: 3 days of investigation period). 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 NCT01945138, 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 31 Jul 2017.