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Preventing Hypoglycemia During Exercise With Proactive Snacking on Closed Loop

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ClinicalTrials.gov Identifier: NCT02135068
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
Jennifer Sherr, Yale University

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Device: Medtronic MiniMed Closed Loop (CL) System Other: Snacking Early Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preventing Hypoglycemia During Exercise With Proactive Snacking on Closed Loop
Study Start Date : January 2015
Actual Primary Completion Date : June 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Chlorine

Arm Intervention/treatment
Experimental: 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
Device: 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.

Other: Snacking
Up to 45 g of oral glucose via Gatorade
Other Name: Oral glucose

Active Comparator: 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
Device: 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.




Primary Outcome Measures :
  1. Nadir blood glucose levels during exercise [ Time Frame: 75 minutes ]
    Difference in the nadir blood glucose levels during exercise between the two study conditions: Closed Loop alone vs. Closed Loop+ snacking.


Secondary Outcome Measures :
  1. Episodes of hypoglycemia (blood glucose <60mg/dL) during exercise [ Time Frame: 75 minutes ]
    Percentage of subjects that required treatment for hypoglycemia during the exercise period between the two study conditions

  2. Mean reduction in blood glucose during exercise [ Time Frame: 75 minutes ]
    Mean Reduction in blood glucose from baseline blood glucose during exercise

  3. Mean time blood glucose in target during exercise [ Time Frame: 75 minutes ]
    Comparison of the mean time blood glucose levels were between 70-180mg/dL during exercise between the two study conditions

  4. Mean time blood glucose levels are in target during the overnight period [ Time Frame: 17 hours ]
    Comparison of the mean time blood glucose levels are in target (70-180mg/dL) during the overnight period after mid-afternoon exercise.

  5. Mean glucose values [ Time Frame: 12 hours ]
    Comparison of the mean daytime and nighttime glucose values

  6. Mean 24- hour glucose levels [ Time Frame: 24 hours ]
    Comparison of the mean 24- hour glucose levels

  7. insulin delivery during CL therapy [ Time Frame: 24 hours ]
    Differences between insulin delivery during CL therapy during the two study conditions (pro-active snacking vs. no snacking) will be assessed.

  8. Incremental meal-related glucose Area Under the Curve [ Time Frame: 24 hours ]
    Assessment of incremental meal related glucose area under the curve will be conducted.

  9. Nadir glucose levels following the meals [ Time Frame: 24 hours ]
    Nadir glucose levels following meals will be compared between the two study conditions

  10. Area under the curve meal-related plasma insulin level excursion following meals [ Time Frame: 24 hours ]
    Area under the curve meal-related insulin excursion following meals.

  11. Nadir glucose levels overnight [ Time Frame: 12 hours ]
    Difference between nadir glucose levels between the two study conditions will be assessed.

  12. Mean absolute relative difference (MARD) for each sensor [ Time Frame: 24 hours ]
    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.

  13. Mean daytime and nighttime glucose values [ Time Frame: 24 hours ]
    Comparison of the mean daytime and nighttime glucose levels



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Ages Eligible for Study:   13 Years to 44 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02135068


Locations
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United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06520
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Jennifer Sherr, MD, PhD Yale University

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Responsible Party: Jennifer Sherr, Instructor, Yale University
ClinicalTrials.gov Identifier: NCT02135068     History of Changes
Other Study ID Numbers: 1403013588
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017

Keywords provided by Jennifer Sherr, Yale University:
type 1 diabetes
closed loop insulin delivery systems
exercise
hypoglycemia

Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Hypoglycemia
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases