Controlled Insulin Delivery: Combining Technology With Treatment

NCT ID: NCT01484457

Last Updated: 2021-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 19 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-07-31
• Study Completion Date: 2010-01-31

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.

Conditions

Diabetes Mellitus, Type 1

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Closed-loop session

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Closed-loop Artificial Pancreas Device

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Juvenile Diabetes Research Foundation

OTHER

Sponsor Role: collaborator

Schneider Children's Medical Center, Israel

OTHER

Sponsor Role: collaborator

Sansum Diabetes Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lois Jovanovic, M.D.

Role: PRINCIPAL_INVESTIGATOR

Sansum Diabetes Research Institute

Locations

Sansum Diabetes Research Institute

Santa Barbara, California, United States

Schneider Children's Medical Center of Israel

Petah Tikva, , Israel

Countries

United States; Israel

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Other Identifiers

JDRF 22-2009-796

Identifier Type: -

Identifier Source: org_study_id