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Accelerometer Use in the Prevention of Exercise-Associated Hypoglycemia in Type 1 Diabetes: Outpatient Exercise Protocol

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02047643
Recruitment Status : Completed
First Posted : January 28, 2014
Results First Posted : October 22, 2019
Last Update Posted : December 27, 2019
Sponsor:
Information provided by (Responsible Party):
Bruce Buckingham, Stanford University

Brief Summary:

Manually suspending an insulin pump at the beginning of aerobic exercise reduces the risk of exercise-associated hypoglycemia (low blood sugar) in patients with type 1 diabetes (T1D). However, since patients with T1D often do not make exercise-related adjustments to their insulin regimen, our group has developed an algorithm to initiate pump suspension in a user-independent manner upon projecting exercise-associated hypoglycemia. The current study seeks to test the efficacy of this algorithm by asking users to participate in a sports camp while wearing an insulin pump, continuous glucose monitor, and accelerometer/heart rate monitor (to detect exercise), which will communicate electronically to a pump shutoff algorithm. On one of the days the algorithm will be used, while on the other day their normal insulin rate will continue for comparative purposes.

The investigators hypothesize that the use of an accelerometer-augmented computer algorithm for insulin pump suspension during exercise will result in significantly fewer episodes of hypoglycemia (both during exercise and in post-exercise monitoring) than in exercise without a pump suspension algorithm.


Condition or disease Intervention/treatment Phase
Type 1 Diabetes Device: Computer algorithm to initiate pump suspension Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description:

randomized crossover design. Subjects with type 1 diabetes participated in a structured soccer session on two separate dates at least one week apart. During one session a subject's basal insulin rate was continued ("off-algorithm"), while during the other session the algorithm (see "algorithm monitoring" below) was in effect ("on-algorithm"); the order of on- versus off-algorithm was chosen at random. The rate of hypoglycemia during exercise were compared between each group.

Hypoglycemia was defined as (1) any meter blood glu

cose (BG) reading of =60 mg/dl, (2) two consecutive meter

BG readings =70 mg/dl done within one hour, or (3) any instance in which carbohydrates were given at a subject's request for symptoms of hypoglycemia (regardless of corre sponding meter BG reading).

Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Accelerometer Use in the Prevention of Exercise-Associated Hypoglycemia in Type 1 Diabetes: Outpatient Exercise Protocol
Actual Study Start Date : March 12, 2014
Actual Primary Completion Date : May 1, 2014
Actual Study Completion Date : May 1, 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: On-algorithm first, then Off-algorithm
Users will participate in two sports camp sessions while wearing an insulin pump, continuous glucose monitor, and accelerometer/heart rate monitor (to detect exercise), which can communicate electronically to a pump shutoff algorithm that insulin delivery should be shut off. On one sports day, the algorithm is turned on; on the other day, the algorithm is turned off.
Device: Computer algorithm to initiate pump suspension
If the computer algorithm senses impending risk for hypoglycemia it sends an alert to an on-site physician to recommend a manual suspension of the subject's insulin pump
Other Name: Augmented predictive low glucose suspend algorithm

Experimental: Off-algorithm first, then On-algorithm
Users will participate in two sports camp sessions while wearing an insulin pump, continuous glucose monitor, and accelerometer/heart rate monitor (to detect exercise), which can communicate electronically to a pump shutoff algorithm that insulin delivery should be shut off. On one sports day, the algorithm is turned on; on the other day, the algorithm is turned off.
Device: Computer algorithm to initiate pump suspension
If the computer algorithm senses impending risk for hypoglycemia it sends an alert to an on-site physician to recommend a manual suspension of the subject's insulin pump
Other Name: Augmented predictive low glucose suspend algorithm




Primary Outcome Measures :
  1. Count of Participants Experiencing a Hypoglycemic Event During Scheduled Exercise [ Time Frame: Measurements occurring during exercise (up to 8 hours) ]
    The primary outcome will be a hypoglycemic event defined as (1) any meter blood glucose (BG) reading of ≤60 mg/dl, (2) two consecutive meter BG readings ≤70 mg/dl done within one hour, or (3) any instance in which carbohydrates were given at a subject's request for symptoms of hypoglycemia


Secondary Outcome Measures :
  1. Count of Participants With Hypoglycemia in the Post Exercise Period [ Time Frame: In the time following exercise until the following morning (up to 24 hours) ]
    A hypoglycemic event was defined as (1) any meter blood glucose (BG) reading of ≤60 mg/dl, (2) two consecutive meter BG readings ≤70 mg/dl done within one hour, or (3) any instance in which carbohydrates were given at a subject's request for symptoms of hypoglycemia



Information from the National Library of Medicine

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Ages Eligible for Study:   8 Years to 25 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Clinical diagnosis of type 1 diabetes for 1-20 years. The diagnosis of type 1 diabetes is based on the investigator's judgment; C peptide level and antibody determinations are not needed.
  • Age 8 to 25 years old.
  • On daily use of an insulin pump and not anticipating a change prior to the subject's completion of the study.
  • Willingness to allow for CGM insertion (if not already using a study-designated CGM) for use during the study.
  • HbA1c <10%.
  • Parent/guardian and subject understand the study protocol and agree to comply with it.
  • Informed Consent Form signed by the parent/guardian and Child Assent Form signed.

Exclusion Criteria:

  • A history of recent injury to body or limb, Addison's disease, muscular disorder, organ/bone marrow transplant, heart disease, or use of any medication or other significant medical disorder if that injury, medication or disease in the judgment of the investigator will affect the completion of the exercise protocol.
  • Current use of glucocorticoid medication (by any route of administration).
  • Current use of a beta blocker medication.
  • Severe hypoglycemia resulting in seizure or loss of consciousness in the four weeks prior to sports camp (if a severe episode occurs after the first but prior to the scheduled second admission, the visit will be deferred).
  • Active infection (if at the time of the planned second visit an infection is present, the visit will be deferred).

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): NCT02047643


Locations
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United States, California
Stanford University
Stanford, California, United States, 94305
Sponsors and Collaborators
Stanford University
Investigators
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Principal Investigator: Bruce A Buckingham, MD Stanford University
Publications of Results:
Other Publications:

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Responsible Party: Bruce Buckingham, Professor of Pediatric Endocrinology, Stanford University
ClinicalTrials.gov Identifier: NCT02047643    
Other Study ID Numbers: 29205
First Posted: January 28, 2014    Key Record Dates
Results First Posted: October 22, 2019
Last Update Posted: December 27, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Bruce Buckingham, Stanford University:
Type 1 diabetes
Hypoglycemia
Accelerometer
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases