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

Primary Purpose

Type 1 Diabetes

Status

Withdrawn

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Hybrid-logic closed loop system

About this trial

This is an interventional treatment trial for Type 1 Diabetes

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Hybrid-logic closed loop system

Arm Description

All patients get to wear the pump. only 1 arm. There is no comparator in this study, as all patients wear the pump.

Outcomes

Primary Outcome Measures

Descriptive endpoints

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

Secondary Outcome Measures

Descriptive endpoints

Serious Adverse Events (SAE)

Full Information

NCT ID

NCT02692547

First Posted

December 3, 2015

Last Updated

January 17, 2018

Sponsor

Medtronic Diabetes

1. Study Identification

Unique Protocol Identification Number

NCT02692547

Brief Title

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

Acronym

DREAMED

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2018

Overall Recruitment Status

Withdrawn

Why Stopped

Study Cancelled

Study Start Date

February 2016 (Actual)

Primary Completion Date

February 2016 (Actual)

Study Completion Date

February 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Medtronic Diabetes

4. Oversight

Data Monitoring Committee

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 1 Diabetes

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Hybrid-logic closed loop system

Arm Type

Other

Arm Description

All patients get to wear the pump. only 1 arm. There is no comparator in this study, as all patients wear the pump.

Intervention Type

Device

Intervention Name(s)

Hybrid-logic closed loop system

Intervention Description

All patients get to wear the pump

Primary Outcome Measure Information:

Title

Descriptive endpoints

Description

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

Time Frame

after 4 days of camp

Secondary Outcome Measure Information:

Title

Descriptive endpoints

Description

Serious Adverse Events (SAE)

Time Frame

after 4 days of camp

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Moshe Philip, MD

Organizational Affiliation

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

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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