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

NCT02692547 | Withdrawn

• 1 other identifier: CEP312
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Type 1 Diabetes

Outcome Measures

Primary Outcomes (1)

• Descriptive endpoints

  Time in different range SG 70 mg/dL ≤ SG ≤ 180 mg/dL

  after 4 days of camp

Secondary Outcomes (1)

• Descriptive endpoints

  after 4 days of camp

Study Arms (1)

Hybrid-logic closed loop system

OTHER

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

Interventions

Hybrid-logic closed loop system DEVICE

All patients get to wear the pump

Hybrid-logic closed loop system

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medtronic Diabetes: lead

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Moshe Philip, MD

  National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 3, 2015
• First Posted: February 26, 2016
• Study Start: February 1, 2016
• Primary Completion: February 1, 2016
• Study Completion: February 1, 2016
• Last Updated: January 19, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share