Overnight Closed Loop Study in U.S. (OCL)

Medtronic

Status: Completed

Conditions: Type 1 Diabetes

Treatments: Device: Hybrid Closed Loop

Study type: Interventional

Funder types: Industry

Identifiers

NCT01857973

CEP273

Details and patient eligibility

About

This is a multicenter feasibility study. Up to 85 subjects will be enrolled in the study. The goal of the study is to demonstrate that the Hybrid Closed Loop (HCL) System is safe to be used in an even larger study outside of hospital.

Full description

Subjects that have met eligibility criteria will undergo treatment with the hybrid closed loop system under various experimental conditions.There is no statistically powered study hypothesis testing.

The investigational centers will be encouraged to include subjects of different ethnicities including Hispanic, Native American, and African-American.

The study is anticipated to last no more than 12 months from investigational center initiation to finalization of all data entry and monitoring procedures. Subjects are expected to participate for approximately 1- 2 months.

Enrollment: 78 patients

Sex: All

Ages: 2 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:

1. Subject is 2-75 years of age at time of screening

2. A clinical diagnosis of type 1 diabetes as determined by either medical record or source documentation from qualified individual to make medical diagnosis

   Exclusion Criteria that are Based on Demands of In-Clinic Study Procedures :

3. Pump therapy for greater than 6 months with use of real time CGM for any period of time (ie. one day) 3 months prior to screening

4. Adequate venous access as assessed by investigator or appropriate staff

5. Subject should have an established insulin carbohydrate and insulin sensitivity ratio.

6. Subject reports at the time of screening that their average fasting glucose is 60 mg/dL - 200 mg/dL

7. Subject reports at the time of screening that their average total daily insulin dose is 15 units - 110 units. (Insulin pump memory for this information may be used)

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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78 participants in 1 patient group

Hybrid Closed Loop

Experimental group

Description:

In-clinic evaluation of the HCL System under various conditions.

Treatment:

Device: Hybrid Closed Loop