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Type 1 Diabetes | Effect of Gain on Closed-Loop Insulin

Type 1 Diabetes research study

What is the primary objective of this study?

The purpose of this study is to test the ability of an advanced external Physiologic Insulin Delivery (ePID) algorithm (a step by step process used to develop a solution to a problem) to get acceptable meal responses over a range of gain. Gain is defined as how much insulin is given in response to a change in a patient's glucose level. This study also examines the effectiveness of the external Physiologic Insulin Delivery (ePID) closed-loop insulin delivery computer software. The investigators would like to assess whether fasting target levels can be achieved as the closed-loop gain increases or decreases, and to evaluate the system's ability to produce an acceptable breakfast meal response.

Who is eligible to participate?

Inclusion Criteria: - Type 1 diabetes for > 3 years - Manage diabetes using a continuous glucose monitor and continuous subcutaneous insulin infusion pump - Non obese (BMI < 30) - Aged 18 - 75 years old - HbA1c < 8 % Exclusion Criteria: - renal or hepatic failure - cancer or lymphoma - Malabsorption or malnourishment - Hypercortisolism - Alcoholism or drug abuse - Anemia (hematocrit < 36 in females and <40 in males) - Eating disorder - Dietary restrictions - Acetaminophen allergy - Chronic acetaminophen use - Glucocorticoid therapy - History of gastroparesis - Use of Beta blockers

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Type 1 Diabetes

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Device:HIGH errorOvernight and breakfast closed-loop control were performed using a target glucose of 120 mg/dL but with the glucose-value-used-for-control equal to 1.33 times the true glucose value (analogous to higher gain lower target).

Device:NO errorOvernight and breakfast closed-loop control were performed using a target glucose of 120 mg/dL and glucose-value-used-for-control equal to the true glucose value.

Device:LOW errorOvernight and breakfast closed-loop control were performed using a target glucose of 120 mg/dL but with the glucose-value-used-for-control equal to 0.8 times the true glucose value (analogous to lower gain higher target).

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

HIGH error, LOW error, NO errorSubjects were randomized to receive overnight and breakfast closed-loop glucose control glucose on three occasions: first with glucose-value-used-for-control higher than blood glucose (HIGH error), then second with glucose-value-used-for-control lower than blood glucose (LOW error), then third with glucose-value-used-for-control equal blood glucose (NO error).

HIGH error, NO error, LOW errorSubjects were randomized to receive overnight and breakfast closed-loop glucose control glucose on three occasions: first with glucose-value-used-for-control higher than blood glucose (HIGH error), then second with glucose-value-used-for-control equal blood glucose (NO error), then third with glucose-value-used-for-control lower than blood glucose (LOW error).

NO error, HIGH error, LOW errorSubjects were randomized to receive overnight and breakfast closed-loop glucose control glucose on three occasions: first with glucose-value-used-for-control equal blood glucose (NO error), then second with glucose-values-used-for-control higher than blood glucose (HIGH error), then third with glucose-value-used-for-control lower than blood glucose (LOW error).

NO error, LOW error, HIGH errorSubjects were randomized to receive overnight and breakfast closed-loop glucose control glucose on three occasions: first with glucose-value-used-for-control equal blood glucose (NO error), then second with glucose-value-used-for-control lower than blood glucose (LOW error), then third with glucose-value-used-for-control higher than blood glucose (HIGH error).

LOW error, NO error, HIGH errorSubjects were randomized to receive overnight and breakfast closed-loop glucose control glucose on three occasions: first with with glucose-value-used-for-control lower than blood glucose (LOW error), then second with glucose-value-used-for-control equal blood glucose (NO error), then third with glucose-value-used-for-control higher than blood glucose (HIGH error).

LOW error, HIGH error, NO errorSubjects were randomized to receive overnight and breakfast closed-loop glucose control glucose on three occasions: first with glucose-value-used-for-control lower than blood glucose (LOW error), then second with glucose-value-used-for-control equal blood glucose (NO error), then third glucose-value-used-for-control higher than blood glucose (HIGH error),

Study Status

Completed

Start Date: December 2013

Completed Date: April 2015

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Glucose Area Under the Curve (AUC) Breakfast

Secondary Outcome: Peak and Nadir Postprandial Glucose Concentration

Study sponsors, principal investigator, and references

Principal Investigator: Howard Wolpert, MD

Lead Sponsor: Joslin Diabetes Center

Collaborator: Juvenile Diabetes Research Foundation

More information:https://clinicaltrials.gov/show/NCT02065895

Steil GM, Panteleon AE, Rebrin K. Closed-loop insulin delivery-the path to physiological glucose control. Adv Drug Deliv Rev. 2004 Feb 10;56(2):125-44. Review.

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