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
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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 |
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Diabetes Mellitus, Type 1 | Device: Closed-loop session | Early Phase 1 |
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 |

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:
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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).

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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Willing to sign the consent form
- Type 1 diabetes for at least 1 year prior to the study
- Using continuous subcutaneous insulin infusion pump
- Above 21 years of age
- Willing to follow the study requirements
Exclusion Criteria:
- Allergy to the sensor or to one of its components
- Psychiatric disorders
- Reported diabetic ketoacidosis within last 3 months
- Abnormal liver function (Transaminase > 2 times the upper limit of normal)
- Heart failure
- Any carcinogenic disease
- Any other chronic abnormality
- Unwilling to perform or to follow the research protocol
- Participation in any other study concurrent with the proposed study
- Creatinine concentration above the upper limit of normal for age and sex
- Active coronary artery disease
- Active gastroparesis
- History of uncontrolled seizures
- Pregnancy
- Untreated adrenal insufficiency
- Hypokalemia
- Uncontrolled thyroid disease.
- Condition, which in the opinion of the investigator, would interfere with patient safety

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
United States, California | |
Sansum Diabetes Research Institute | |
Santa Barbara, California, United States, 93105 | |
Israel | |
Schneider Children's Medical Center of Israel | |
Petah Tikva, Israel |
Principal Investigator: | Lois Jovanovic, M.D. | Sansum Diabetes Research Institute |
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 |
Diabetes Mellitus Closed Loop Artificial Pancreas |
Diabetes Mellitus Diabetes Mellitus, Type 1 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Autoimmune Diseases Immune System Diseases Pancrelipase Gastrointestinal Agents |