Closed Loop Insulin Pump Therapy After Islet Auto-Transplantation

June 30, 2017 updated by: University of Minnesota

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).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
        • University of Minnesota

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patients undergoing total pancreatectomy and islet auto-transplantation.
  • Patients ages 21 to 64 years old

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
No Intervention: Control
Control Group: patients receive conventional multiple daily injection insulin therapy with basal and bolus dosing during the 72 hour study period.
Experimental: Closed Loop Insulin
Closed Loop Insulin Group: patients receive continuous subcutaneous insulin controlled by experimental closed loop system during the 72 hour study period.
Device: Closed Loop Insulin
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).
Other Names:
  • Medtronic ePID 2.0 system
  • Medtronic Paradigm REAL-Time Insulin Pump (MMT-722)
  • Enlite Glucose Sensor (MMT-7008X)
  • MiniLink REAL-Time Transmitter (MMT-7703XNA)
  • ComLink Device (MMT-7304)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
3 days of investigation period
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.
3 days of investigation period

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Study Period: Continuous Glucose Monitor (CGM) BG Average
Time Frame: continuously over the 72 hour investigational period
Continuous glucose monitoring sensor data: The CGM's in the pump and control groups will collect glucose readings continuously over a 72 hour period
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
measure of glycemic variability by CGM. This is the standard deviation within each patient for all CGM glucose readings.
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
Additional measure of glycemic variability, as reflected by CGM measures, % time in the range of 70-140 on CGM
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
Calculated as the area under the curve on the CGM tracing that the glucose is under 70 mg/dL.
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
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
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
continuous over the 72 hour investigation period
Study Period: Morning C-peptide
Time Frame: Average of 3 day study period
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.
Average of 3 day study period
Study Period: Daily Insulin Needs
Time Frame: Average of 3 day study period
Calculated as total daily dose of insulin.
Average of 3 day study period
Day 14 Follow-Up: Average Serum BG
Time Frame: Day 14 Follow-Up
Day 14 Follow-Up
Day 14 Follow-Up: C-Peptide
Time Frame: Day 14 Follow-Up:
Day 14 Follow-Up:
Day 28 Follow-Up: Average Serum BG
Time Frame: Day 28 Follow-Up
Day 28 Follow-Up
Day 28 Follow-Up: C-Peptide
Time Frame: Day 28 Follow-Up
Day 28 Follow-Up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Minnesota

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medtronic Diabetes

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Melena Bellin, MD, University of Minnesota

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 13, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 18, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 31, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 30, 2017

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CLTPIAT2013
  • 21856 (Other Grant/Funding Number: University of Minnesota - CTSI)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Diabetes Mellitus

Clinical Trials on Closed Loop Insulin

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings