Preventing Hypoglycemia During Exercise With Proactive Snacking on Closed Loop

NCT ID: NCT02135068

Last Updated: 2020-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2016-12-31

Brief Summary

This study is designed to look at how snacking during exercise may help prevent low blood sugars while subjects are on the "closed loop artificial pancreas." This system uses a continuous glucose sensor, an insulin pump, and a computer program that automatically determines how much insulin to give based on the sensor glucose level.

Detailed Description

This study will be a randomized cross-over study as subjects will be studied under both study conditions - Closed Loop (CL) alone vs. CL + proactive snacking protocol). Differences in the nadir blood glucose levels during exercise between the two study conditions will be the primary outcome measure.

Conditions

Type 1 Diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CL and exercise with proactive snacking

Subject will consume oral glucose prior to starting exercise regimen while on the Medtronic MiniMed Closed Loop (CL) System

Group Type: EXPERIMENTAL

Medtronic MiniMed Closed Loop (CL) System

Intervention Type: DEVICE

The Medtronic MiniMed Closed Loop (CL) System is an investigational system that uses some commercially available products. An investigational Enlite 2 glucose sensor measures the sensor glucose. The glucose sensor signal is sent to the insulin pump. From the insulin pump the sensor glucose is sent through the translator, which then relays the signal on to a controller. An Android Mobile Device (off the shelf) has the control algorithm installed. This device is known as the controller. The controller serves as the control center for the Android system, receiving data from the sensor and pump components, feeding the data to its control algorithm, issuing delivery commands to the pump to apply the algorithm's recommend therapy, and providing a means to monitor the system.

Snacking

Intervention Type: OTHER

Up to 45 g of oral glucose via Gatorade

CL and exercise without proactive snacking

Subject will not consume oral glucose prior to starting exercise regimen while on the Medtronic MiniMed Closed Loop (CL) System

Group Type: ACTIVE_COMPARATOR

Medtronic MiniMed Closed Loop (CL) System

Intervention Type: DEVICE

The Medtronic MiniMed Closed Loop (CL) System is an investigational system that uses some commercially available products. An investigational Enlite 2 glucose sensor measures the sensor glucose. The glucose sensor signal is sent to the insulin pump. From the insulin pump the sensor glucose is sent through the translator, which then relays the signal on to a controller. An Android Mobile Device (off the shelf) has the control algorithm installed. This device is known as the controller. The controller serves as the control center for the Android system, receiving data from the sensor and pump components, feeding the data to its control algorithm, issuing delivery commands to the pump to apply the algorithm's recommend therapy, and providing a means to monitor the system.

Interventions

Medtronic MiniMed Closed Loop (CL) System

The Medtronic MiniMed Closed Loop (CL) System is an investigational system that uses some commercially available products. An investigational Enlite 2 glucose sensor measures the sensor glucose. The glucose sensor signal is sent to the insulin pump. From the insulin pump the sensor glucose is sent through the translator, which then relays the signal on to a controller. An Android Mobile Device (off the shelf) has the control algorithm installed. This device is known as the controller. The controller serves as the control center for the Android system, receiving data from the sensor and pump components, feeding the data to its control algorithm, issuing delivery commands to the pump to apply the algorithm's recommend therapy, and providing a means to monitor the system.

Intervention Type: DEVICE

Snacking

Up to 45 g of oral glucose via Gatorade

Intervention Type: OTHER

Other Intervention Names

Oral glucose

Eligibility Criteria

Inclusion Criteria

1. Age 13-45 years

2. Clinical diagnosis of T1D (formal antibody and/or genetic testing will not be required)

3. Duration of T1D ≥ 1 year

4. HbA1c ≤ 9 %

5. Treated with continuous subcutaneous insulin infusion (pump) for at least 3 months

6. Body weight > 40 kg (to accommodate phlebotomy)

7. Able to tolerate a 75-minute exercise period of moderate intensity

8. Be willing to wear 2 subcutaneous glucose sensors (placed under the skin like a pump site) simultaneously during the inpatient portions of this study.

9. Be in good general health without other acute or chronic illness that in the judgment of the investigator could interfere with the study or jeopardize subject safety

10. Normal hematocrit

11. Able to give consent (for children <18 years, permission from parents and subject assent will be required)

12. Female subjects of reproductive potential must be abstinent or consistently using appropriate family planning methods.

Exclusion Criteria

1. Insulin resistant (defined as requiring > 1.5 units/kg/day at time of study enrollment)

2. Presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct

3. Use of any medications (besides insulin) known to effect blood glucose levels, including oral or other systemic glucocorticoid therapy. Inhaled, intranasal, or rectal corticosteroid use is allowed along as not given within 2 weeks of the closed loop admissions. Use of topical glucocorticoids is allowable as long as affected skin area does not overlap with study device sites.

4. Subjects using herbal supplements will be excluded, due to the unknown effects of these supplements on glucose control

5. History of hypoglycemic seizure within last 3 months

6. Female subjects who are pregnant, lactating, or unwilling to be tested for pregnancy

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 44 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Jennifer Sherr

Instructor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jennifer Sherr, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Yale University School of Medicine

New Haven, Connecticut, United States

Countries

United States

Other Identifiers

T32DK063703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

1403013588

Identifier Type: -

Identifier Source: org_study_id