Clinical trial NCT02692547: Feasibility Study to Evaluate the Hybrid-Logic Closed Loop System in Type 1 Diabetes
Official title: Feasibility Study to Evaluate the Hybrid-Logic Closed Loop System in Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Type 1 Diabetes
Lead sponsor: Medtronic Diabetes
Sponsor class: INDUSTRY
First posted: 2016-02-26
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Detailed description: 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)

Eligibility criteria: Inclusion Criteria:

1. Diabetes duration \> 1 year since diagnosis
2. Sensor augmented Pump for at least 6 months
3. Age 18-25
4. A1C \<10.0 at time of screening visit
5. Willing to follow study instructions
6. Willing to perform ≥ 5 finger stick blood glucose measurements daily
7. Willing to perform required sensor calibrations
8. Patient capable of reading and understand instructions in English

Exclusion Criteria:

1. Subject is unable to tolerate tape adhesive in the area of sensor placement
2. Subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g., psoriasis, rash, Staphylococcus infection)
3. 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
4. Subject has a positive pregnancy screening test
5. 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
6. Subject has had a hypoglycemic seizure within the past 6 months prior to screening visit
7. Subject has had hypoglycemia resulting in loss of consciousness within the past 6 months prior to screening visit
8. Subject has had an episode of diabetic ketoacidosis (DKA) within the past 6 months prior to screening visit
9. Subject has a history of a seizure disorder
10. Subject has central nervous system or cardiac disorder resulting in syncope
11. 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
12. Subjects with hematocrit lower than the normal reference range per POC or local lab testing
13. Subjects with a history or findings on screening electrocardiogram (EKG) of any cardiac arrhythmia, including atrial arrhythmias
14. Subjects with a history of adrenal insufficiency
15. Subjects with history of migraines that have occurred at least 2 times in the last 3 months prior to enrollment

Primary outcomes:
measure: Descriptive endpoints
timeFrame: after 4 days of camp
Secondary outcomes:
measure: Descriptive endpoints
timeFrame: after 4 days of camp
Other outcomes:
Locations:
Study officials:
affiliation: National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel
name: Moshe Philip, MD
role: PRINCIPAL_INVESTIGATOR
References: