Feasibility Study to Evaluate the Hybrid-Logic Closed Loop System in Type 1 Diabetes

Study Overview
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Brief Summary
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The purpose of this study is to collect data on the feasibility of the HLCL system in a camp setting.

Detailed Description
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This study is a single-arm, single-center, in clinic Investigation in subjects with type 1 diabetes on insulin pump therapy. Run-in Period A total of up 10 subjects will be enrolled (age 18-25). A minimum of 6 days run-in period with the 640G (sensor augmented pump) will be used to collect sensors and insulin data and to allow the subject to become familiar. Study Period - Camp Following the run-in period subjects will participate in a 5 day, 4 night study period in an camp setting during which the CL feature will be studied. Subjects will receive 3 meals each day, one night they receive a high fat dinner, one morning they will receive breakfast high in carbohydrates. Subjects will be asked to exercise for up to 60 minutes on one day during their study period. Subjects will be asked to take a minimum of 5 fingersticks a day (before each meal, morning and before bedtime)

Official Title
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Feasibility Study to Evaluate the Hybrid-Logic Closed Loop System in Type 1 Diabetes

Conditions
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Type 1 Diabetes

Intervention / Treatment
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* Device: Hybrid-logic closed loop system


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diabetes duration > 1 year since diagnosis Sensor augmented Pump for at least 6 months Age 18-25 A1C <10.0 at time of screening visit Willing to follow study instructions Willing to perform ≥ 5 finger stick blood glucose measurements daily Willing to perform required sensor calibrations Patient capable of reading and understand instructions in English Exclusion Criteria: Subject is unable to tolerate tape adhesive in the area of sensor placement Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection) Subject is actively participating in an investigational study (drug or device) wherein they have received treatment from an investigational study (drug or device) in the last 2 weeks Subject has a positive pregnancy screening test Subject is female, sexually active without the use of contraception, and plans/able to become pregnant during the course of the study and is not using an acceptable method of contraception Subject has had a hypoglycemic seizure within the past 6 months prior to screening visit Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to screening visit Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to screening visit Subject has a history of a seizure disorder Subject has central nervous system or cardiac disorder resulting in syncope Subject has a history of myocardial infarction, unstable angina, coronary artery bypass surgery, coronary artery stenting, transient ischemic attack (TIA), cerebrovascular accident (CVA), angina, congestive heart failure, ventricular rhythm disturbances or thromboembolic disease Subjects with hematocrit lower than the normal reference range per POC or local lab testing Subjects with a history or findings on screening electrocardiogram (EKG) of any cardiac arrhythmia, including atrial arrhythmias Subjects with a history of adrenal insufficiency Subjects with history of migraines that have occurred at least 2 times in the last 3 months prior to enrollment

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Hybrid-logic closed loop system<br>All patients get to wear the pump. only 1 arm. There is no comparator in this study, as all patients wear the pump. | Device: Hybrid-logic closed loop system<br>* All patients get to wear the pump<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descriptive endpoints | Time in different range SG 70 mg/dL ≤ SG ≤ 180 mg/dL | after 4 days of camp | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descriptive endpoints | Serious Adverse Events (SAE) | after 4 days of camp |