N/A
Completed N=18
Accelerometer Use in the Prevention of Exercise-Associated Hypoglycemia in Type 1 Diabetes: Outpatient Exercise Protocol
Source: ClinicalTrials.gov NCT02047643 ↗Enrolled (actual)
18
Serious AEs
0.0%
Results posted
Oct 2019
Primary outcomePrimary: Count of Participants Experiencing a Hypoglycemic Event During Scheduled Exercise — 3; 6 Participants — p=.45
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Count of Participants Experiencing a Hypoglycemic Event During Scheduled Exercise |
3; 6 | .45 |
| SECONDARY Count of Participants With Hypoglycemia in the Post Exercise Period |
2; 4 | .66 |
Eligibility 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).
Data sourced from ClinicalTrials.gov (NCT02047643). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.