Controlled Insulin Delivery: Combining Technology With Treatment
|ClinicalTrials.gov Identifier: NCT01484457|
Recruitment Status : Completed
First Posted : December 2, 2011
Last Update Posted : June 7, 2012
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|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||19 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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:
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
- 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.
- 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).
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01484457
|United States, California|
|Sansum Diabetes Research Institute|
|Santa Barbara, California, United States, 93105|
|Schneider Children's Medical Center of Israel|
|Petah Tikva, Israel|
|Principal Investigator:||Lois Jovanovic, M.D.||Sansum Diabetes Research Institute|