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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 : March 23, 2021
Sponsor:
Collaborators:
Juvenile Diabetes Research Foundation
Schneider Children's Medical Center, Israel
Information provided by (Responsible Party):
Sansum Diabetes Research Institute

Tracking Information
First Submitted Date  ICMJE November 15, 2011
First Posted Date  ICMJE December 2, 2011
Last Update Posted Date March 23, 2021
Study Start Date  ICMJE July 2008
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 18, 2021)
Restoration of Euglycemia [ Time Frame: 12 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. The patients will be followed for the duration of the 12 hour study.
Original Primary Outcome Measures  ICMJE
 (submitted: November 30, 2011)
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.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 18, 2021)
Average percent-of-time-in-range (80 - 180 mg/dL) [ Time Frame: 12 hours ]
All reported blood glucose values per both CGM and YSI ware analyzed for average percent-of-time-in-range (80 - 180 mg/dL). The participants will be followed for the duration of the 12 hour study.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 30, 2011)
Average percent-of-time-in-range (80 - 180 mg/dL) [ Time Frame: one year ]
All reported blood glucose values per both CGM and YSI ware analyzed for average percent-of-time-in-range (80 - 180 mg/dL).
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Controlled Insulin Delivery: Combining Technology With Treatment
Official Title  ICMJE Controlled Insulin Delivery: Combining Technology With 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Diabetes Mellitus, Type 1
Intervention  ICMJE 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
Study Arms  ICMJE 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).
Intervention: Device: Closed-loop session
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 30, 2011)
19
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2010
Actual Primary Completion Date January 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Israel,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01484457
Other Study ID Numbers  ICMJE JDRF 22-2009-796
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Sansum Diabetes Research Institute
Study Sponsor  ICMJE Sansum Diabetes Research Institute
Collaborators  ICMJE
  • Juvenile Diabetes Research Foundation
  • Schneider Children's Medical Center, Israel
Investigators  ICMJE
Principal Investigator: Lois Jovanovic, M.D. Sansum Diabetes Research Institute
PRS Account Sansum Diabetes Research Institute
Verification Date March 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP