Clinical trial NCT01484457: Controlled Insulin Delivery: Combining Technology With Treatment
Official title: Controlled Insulin Delivery: Combining Technology With Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Diabetes Mellitus, Type 1
Keywords: Diabetes Mellitus
Closed Loop
Artificial Pancreas
Lead sponsor: Sansum Diabetes Research Institute
Sponsor class: OTHER
Collaborators: name: Juvenile Diabetes Research Foundation
name: Schneider Children's Medical Center, Israel
First posted: 2011-12-02
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Restoration of Euglycemia
timeFrame: 12 hours
Secondary outcomes:
measure: Average percent-of-time-in-range (80 - 180 mg/dL)
timeFrame: 12 hours
Other outcomes:
Locations:
city: Santa Barbara
country: United States
facility: Sansum Diabetes Research Institute
state: California
city: Petah Tikva
country: Israel
facility: Schneider Children's Medical Center of Israel
Study officials:
affiliation: Sansum Diabetes Research Institute
name: Lois Jovanovic, M.D.
role: PRINCIPAL_INVESTIGATOR
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