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

Completed · Not applicable

Conditions studied: Type 1 Diabetes

In brief

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.

Key facts

Study ID

NCT02047643

Run by

Stanford University

People needed

18

Starts

2014-03-12

Expected to finish

2014-05-01

Last updated by the study team

2019-12-27

Who can join

Age: 8 and older, up to 25. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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).

Where it is running

• Stanford University — Stanford, California, United States

Full record on ClinicalTrials.gov

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