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Completed

NCT Number: NCT01945138

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).

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Key information

Conditions

Chronic Pancreatitis Chronic Disease Diabetes Mellitus Digestive System Diseases Disease Attributes Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases Pancreatic Diseases Pancreatitis Pancreatitis, Chronic Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

21 year–64 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Minnesota

Minneapolis, Minnesota, 55454, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Closed Loop Insulin

Device

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)

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. 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

  2. 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.

  3. 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

  4. 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.

  5. Study Period: % of Time CGM BG <70 mg/dL

    Time frame: continuous over the 72 hour investigation period

  6. Study Period: CGM AUC With Glucose> 140 mg/dL

    Time frame: continuous over the 72 hour investigation period

  7. Study Period: % of Time CGM BG > 140 mg/dL

    Time frame: continuous over the 72 hour investigation period

  8. 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.

  9. Study Period: Daily Insulin Needs

    Time frame: Average of 3 day study period

    Calculated as total daily dose of insulin.

  10. Day 14 Follow-Up: Average Serum BG

    Time frame: Day 14 Follow-Up

  11. Day 14 Follow-Up: C-Peptide

    Time frame: Day 14 Follow-Up:

  12. Day 28 Follow-Up: Average Serum BG

    Time frame: Day 28 Follow-Up

  13. Day 28 Follow-Up: C-Peptide

    Time frame: Day 28 Follow-Up

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • Medtronic MiniMed, Inc.

Registry information

Official study title

Efficacy and Feasibility of Fully Automated Closed Loop Insulin Pump Therapy After Islet Auto-Transplantation

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 18, 2013
Registry last updated
Jul 31, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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