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Controlled Insulin Delivery: Combining Technology With Treatment

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ClinicalTrials.gov Identifier: NCT01484457
Recruitment Status : Completed
First Posted : December 2, 2011
Last Update Posted : June 7, 2012
Sponsor:
Collaborators:
Juvenile Diabetes Research Foundation
Schneider Children's Medical Center, Israel
Information provided by (Responsible Party):
Lois Jovanovic, MD, Sansum Diabetes Research Institute

Study Description
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Brief Summary:

Hypothesis: Closed-loop control systems for an artificial pancreas using multi-parametric model predictive control can be developed and evaluated safely in patients with Type 1 Diabetes Mellitus (T1DM) to control blood glucose concentrations.

This study seeks to combine real-time continuous glucose sensing with automated insulin delivery in a closed-loop system that will achieve euglycemia in patients with T1DM. The end result of this line of research will be an artificial pancreas that will provide around-the-clock glucose regulation through controlled insulin delivery in response to detected patterns of change in glucose levels.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Device: Closed-loop session Early Phase 1

Detailed Description:
The goal of the JDRF Artificial Pancreas Project is to produce an autonomous artificial pancreas that can safely and effectively regulate glycemia in people with type 1 diabetes mellitus. In our work, this fully automated closed-loop system combines a subcutaneous continuous glucose monitor (CGM) and a continuous subcutaneous insulin infusion (CSII) pump with a sophisticated control algorithm. This is a proof-of-concept study to demonstrate that the controller could bring the patient back to a relatively normal glucose concentration after an unannounced meal and from mild hyperglycemia. Once the system is initiated, all insulin delivery is calculated automatically. There was no outside intervention either by the subject or medical personnel. An artificial pancreas system that aims at replicating normal beta-cell function by using the subcutaneous-subcutaneous (sc-sc) route needs to address inherent delays in both glucose sensing and insulin delivery. Our strategic approach is that a closed-loop system should operate safely without any knowledge of meals or other disturbances. We have developed the Artificial Pancreas System (APS©) and used it to clinically evaluate a control strategy that allows efficient glycemic control without any a priori meal information. The Artificial Pancreas device uses the Artificial Pancreas System (APS©) platform with the OmniPod insulin pump, the DexCom SEVEN PLUS CGM and a multi-parametric model predictive control algorithm (mpMPC) with an insulin-on-board (IOB) safety constraint.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Controlled Insulin Delivery: Combining Technology With Treatment
Study Start Date : July 2008
Actual Primary Completion Date : January 2010
Actual Study Completion Date : January 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diabetes Type 1

Arms and Interventions
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Arm Intervention/treatment
Experimental: Closed-loop control system

The objective of this study is to automate glucose control in subjects with type 1 diabetes using a computer control algorithm in a controlled in-clinic research setting.

The controller will be evaluated under two conditions:

  1. restoring euglycemia (80-140 mg/dL) when the controller is initiated during a period when the subject's glucose is above the euglycemic range;
  2. restoring euglycemia (80-140 mg/dL) when the controller is challenged with a small unannounced meal (~25 g CHO).
 Device: Closed-loop session

Subjects will arrive fasting at 7am unless needed for hypoglycemia (glucose < 70 mg/dL) and no extra bolus insulin after 3am. An IV catheter will be inserted for blood samples and for IV administration of glucose if necessary. Blood samples will be analyzed for glucose by YSI 2300Stat every 30 minutes.

Breakfast consisting of 25g of CHO will be eaten at 7:30 am and the subject will bolus for this amount of CHO. The controller is switched "on" on the down slope of the meal response, and the subject is brought to a basal steady-state by the controller. Target blood glucose is 110 ± 30-mg/dL.

After approximately 3 hours a small lunch will be eaten consisting of 25g of CHO (unannounced meal challenge). The subject will be monitored until blood glucose returns to euglycemia.

Other Name: Closed-loop Artificial Pancreas Device


Outcome Measures
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Primary Outcome Measures :
  1. Restoration of Euglycemia [ Time Frame: 24 hours ]
    The primary endpoint of this pilot study is successful restoration of euglycemia from the two perturbed conditions using closed loop control with minimal hypo- and hyperglycemia exposure. The first condition involves restoration of euglycemia when the subject is in a hyperglycemic state. The second condition involves restoration of euglycemia following consumption of a meal containing 25g CHO with no insulin bolus.


Secondary Outcome Measures :
  1. Average percent-of-time-in-range (80 - 180 mg/dL) [ Time Frame: 24 hours ]
    All reported blood glucose values per both CGM and YSI ware analyzed for average percent-of-time-in-range (80 - 180 mg/dL).


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Willing to sign the consent form
  2. Type 1 diabetes for at least 1 year prior to the study
  3. Using continuous subcutaneous insulin infusion pump
  4. Above 21 years of age
  5. Willing to follow the study requirements

Exclusion Criteria:

  1. Allergy to the sensor or to one of its components
  2. Psychiatric disorders
  3. Reported diabetic ketoacidosis within last 3 months
  4. Abnormal liver function (Transaminase > 2 times the upper limit of normal)
  5. Heart failure
  6. Any carcinogenic disease
  7. Any other chronic abnormality
  8. Unwilling to perform or to follow the research protocol
  9. Participation in any other study concurrent with the proposed study
  10. Creatinine concentration above the upper limit of normal for age and sex
  11. Active coronary artery disease
  12. Active gastroparesis
  13. History of uncontrolled seizures
  14. Pregnancy
  15. Untreated adrenal insufficiency
  16. Hypokalemia
  17. Uncontrolled thyroid disease.
  18. Condition, which in the opinion of the investigator, would interfere with patient safety
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01484457


Locations
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United States, California
Sansum Diabetes Research Institute
Santa Barbara, California, United States, 93105
Israel
Schneider Children's Medical Center of Israel
Petah Tikva, Israel
Sponsors and Collaborators
Sansum Diabetes Research Institute
Juvenile Diabetes Research Foundation
Schneider Children's Medical Center, Israel
Investigators
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Principal Investigator: Lois Jovanovic, M.D. Sansum Diabetes Research Institute
More Information
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Publications:

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Responsible Party: Lois Jovanovic, MD, CEO and Chief Scientific Officer, Sansum Diabetes Research Institute
ClinicalTrials.gov Identifier: NCT01484457    
Other Study ID Numbers: JDRF 22-2009-796
First Posted: December 2, 2011    Key Record Dates
Last Update Posted: June 7, 2012
Last Verified: June 2012
Keywords provided by Lois Jovanovic, MD, Sansum Diabetes Research Institute:
Diabetes Mellitus
Closed Loop
Artificial Pancreas
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
 Autoimmune Diseases
Immune System Diseases
Pancrelipase
Gastrointestinal Agents