N/A Completed N=8 Randomized Basic Science

Effect of Gain on Closed-Loop Insulin

Type 1 Diabetes

Source: ClinicalTrials.gov NCT02065895 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Apr 2018

Primary outcomePrimary: Glucose Area Under the Curve (AUC) Breakfast — 66.8; 48.8; 37.4 mmol/l/min — p=0.0011

Summary

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Glucose Area Under the Curve (AUC) Breakfast	66.8; 48.8; 37.4	0.0011 sig
SECONDARY Peak and Nadir Postprandial Glucose Concentration	13.3; 11.8; 11.3; 4.5; 4.8; 6.6	0.0059 sig

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02065895). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.