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

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

Study Overview

• Status: Withdrawn
• Conditions: Type 1 Diabetes
• Intervention / Treatment: Device: Hybrid-logic closed loop system

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)

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Hybrid-logic closed loop system; 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; All patients get to wear the pump

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Medtronic Diabetes
• Investigators: Principal Investigator: Moshe Philip, MD, National Center for Childhood Diabetes, Schneider Children's Medical Center of Israel

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2016
• Primary Completion (Actual): February 1, 2016
• Study Completion (Actual): February 1, 2016

Study Registration Dates

• First Submitted: December 3, 2015
• First Submitted That Met QC Criteria: February 22, 2016
• First Posted (Estimate): February 26, 2016

Study Record Updates

• Last Update Posted (Actual): January 19, 2018
• Last Update Submitted That Met QC Criteria: January 17, 2018
• Last Verified: January 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: CEP312

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO