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Preventing Hypoglycemia During Exercise With Proactive Snacking on Closed Loop

Primary Purpose

Type 1 Diabetes

Status

Completed

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Medtronic MiniMed Closed Loop (CL) System

Snacking

About this trial

This is an interventional treatment trial for Type 1 Diabetes focused on measuring type 1 diabetes, closed loop insulin delivery systems, exercise, hypoglycemia

Eligibility Criteria

13 Years - 44 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Age 13-45 years
Clinical diagnosis of T1D (formal antibody and/or genetic testing will not be required)
Duration of T1D ≥ 1 year
HbA1c ≤ 9 %
Treated with continuous subcutaneous insulin infusion (pump) for at least 3 months
Body weight > 40 kg (to accommodate phlebotomy)
Able to tolerate a 75-minute exercise period of moderate intensity
Be willing to wear 2 subcutaneous glucose sensors (placed under the skin like a pump site) simultaneously during the inpatient portions of this study.
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
Normal hematocrit
Able to give consent (for children <18 years, permission from parents and subject assent will be required)
Female subjects of reproductive potential must be abstinent or consistently using appropriate family planning methods.

Exclusion Criteria:

Insulin resistant (defined as requiring > 1.5 units/kg/day at time of study enrollment)
Presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct
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.
Subjects using herbal supplements will be excluded, due to the unknown effects of these supplements on glucose control
History of hypoglycemic seizure within last 3 months
Female subjects who are pregnant, lactating, or unwilling to be tested for pregnancy

Sites / Locations

Yale University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CL and exercise with proactive snacking

CL and exercise without proactive snacking

Arm Description

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

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

Outcomes

Primary Outcome Measures

Nadir blood glucose levels during exercise

Difference in the nadir blood glucose levels during exercise between the two study conditions: Closed Loop alone vs. Closed Loop+ snacking.

Secondary Outcome Measures

Episodes of hypoglycemia (blood glucose <60mg/dL) during exercise

Percentage of subjects that required treatment for hypoglycemia during the exercise period between the two study conditions

Mean reduction in blood glucose during exercise

Mean Reduction in blood glucose from baseline blood glucose during exercise

Mean time blood glucose in target during exercise

Comparison of the mean time blood glucose levels were between 70-180mg/dL during exercise between the two study conditions

Mean time blood glucose levels are in target during the overnight period

Comparison of the mean time blood glucose levels are in target (70-180mg/dL) during the overnight period after mid-afternoon exercise.

Mean glucose values

Comparison of the mean daytime and nighttime glucose values

Mean 24- hour glucose levels

Comparison of the mean 24- hour glucose levels

insulin delivery during CL therapy

Differences between insulin delivery during CL therapy during the two study conditions (pro-active snacking vs. no snacking) will be assessed.

Incremental meal-related glucose Area Under the Curve

Assessment of incremental meal related glucose area under the curve will be conducted.

Nadir glucose levels following the meals

Nadir glucose levels following meals will be compared between the two study conditions

Area under the curve meal-related plasma insulin level excursion following meals

Area under the curve meal-related insulin excursion following meals.

Nadir glucose levels overnight

Difference between nadir glucose levels between the two study conditions will be assessed.

Mean absolute relative difference (MARD) for each sensor

Calculation and comparison of the mean absolute relative difference for each sensor will be performed and comparisons between accuracy of the sensors will be done.

Mean daytime and nighttime glucose values

Comparison of the mean daytime and nighttime glucose levels

Full Information

NCT ID

NCT02135068

First Posted

April 16, 2014

Last Updated

April 16, 2020

Sponsor

Yale University

Collaborators

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

1. Study Identification

Unique Protocol Identification Number

NCT02135068

Brief Title

Preventing Hypoglycemia During Exercise With Proactive Snacking on Closed Loop

Official Title

Preventing Hypoglycemia During Exercise With Proactive Snacking on Closed Loop

Study Type

Interventional

2. Study Status

Record Verification Date

April 2020

Overall Recruitment Status

Completed

Study Start Date

January 2015 (undefined)

Primary Completion Date

June 2016 (Actual)

Study Completion Date

December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Yale University

Collaborators

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

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

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

Type 1 Diabetes

Keywords

type 1 diabetes, closed loop insulin delivery systems, exercise, hypoglycemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CL and exercise with proactive snacking

Arm Type

Experimental

Arm Description

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

Arm Title

CL and exercise without proactive snacking

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Device

Intervention Name(s)

Medtronic MiniMed Closed Loop (CL) System

Intervention Description

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

Other

Intervention Name(s)

Snacking

Other Intervention Name(s)

Oral glucose

Intervention Description

Up to 45 g of oral glucose via Gatorade

Primary Outcome Measure Information:

Title

Nadir blood glucose levels during exercise

Description

Difference in the nadir blood glucose levels during exercise between the two study conditions: Closed Loop alone vs. Closed Loop+ snacking.

Time Frame

75 minutes

Secondary Outcome Measure Information:

Title

Episodes of hypoglycemia (blood glucose <60mg/dL) during exercise

Description

Percentage of subjects that required treatment for hypoglycemia during the exercise period between the two study conditions

Time Frame

75 minutes

Title

Mean reduction in blood glucose during exercise

Description

Mean Reduction in blood glucose from baseline blood glucose during exercise

Time Frame

75 minutes

Title

Mean time blood glucose in target during exercise

Description

Comparison of the mean time blood glucose levels were between 70-180mg/dL during exercise between the two study conditions

Time Frame

75 minutes

Title

Mean time blood glucose levels are in target during the overnight period

Description

Comparison of the mean time blood glucose levels are in target (70-180mg/dL) during the overnight period after mid-afternoon exercise.

Time Frame

17 hours

Title

Mean glucose values

Description

Comparison of the mean daytime and nighttime glucose values

Time Frame

12 hours

Title

Mean 24- hour glucose levels

Description

Comparison of the mean 24- hour glucose levels

Time Frame

24 hours

Title

insulin delivery during CL therapy

Description

Differences between insulin delivery during CL therapy during the two study conditions (pro-active snacking vs. no snacking) will be assessed.

Time Frame

24 hours

Title

Incremental meal-related glucose Area Under the Curve

Description

Assessment of incremental meal related glucose area under the curve will be conducted.

Time Frame

24 hours

Title

Nadir glucose levels following the meals

Description

Nadir glucose levels following meals will be compared between the two study conditions

Time Frame

24 hours

Title

Area under the curve meal-related plasma insulin level excursion following meals

Description

Area under the curve meal-related insulin excursion following meals.

Time Frame

24 hours

Title

Nadir glucose levels overnight

Description

Difference between nadir glucose levels between the two study conditions will be assessed.

Time Frame

12 hours

Title

Mean absolute relative difference (MARD) for each sensor

Description

Calculation and comparison of the mean absolute relative difference for each sensor will be performed and comparisons between accuracy of the sensors will be done.

Time Frame

24 hours

Title

Mean daytime and nighttime glucose values

Description

Comparison of the mean daytime and nighttime glucose levels

Time Frame

24 hours

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Maximum Age & Unit of Time

44 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Age 13-45 years Clinical diagnosis of T1D (formal antibody and/or genetic testing will not be required) Duration of T1D ≥ 1 year HbA1c ≤ 9 % Treated with continuous subcutaneous insulin infusion (pump) for at least 3 months Body weight > 40 kg (to accommodate phlebotomy) Able to tolerate a 75-minute exercise period of moderate intensity Be willing to wear 2 subcutaneous glucose sensors (placed under the skin like a pump site) simultaneously during the inpatient portions of this study. 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 Normal hematocrit Able to give consent (for children <18 years, permission from parents and subject assent will be required) Female subjects of reproductive potential must be abstinent or consistently using appropriate family planning methods. Exclusion Criteria: Insulin resistant (defined as requiring > 1.5 units/kg/day at time of study enrollment) Presence of any medical or psychiatric disorder that may interfere with subject safety or study conduct 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. Subjects using herbal supplements will be excluded, due to the unknown effects of these supplements on glucose control History of hypoglycemic seizure within last 3 months Female subjects who are pregnant, lactating, or unwilling to be tested for pregnancy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jennifer Sherr, MD, PhD

Organizational Affiliation

Yale University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Yale University School of Medicine

City

New Haven

State/Province

Connecticut

ZIP/Postal Code

06520

Country

United States

12. IPD Sharing Statement

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Preventing Hypoglycemia During Exercise With Proactive Snacking on Closed Loop

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