Adjusting Insulin Delivery to Activity
Completed · Not applicable
Conditions studied: Diabetes, Nocturnal Hypoglycemia
In brief
Increased daytime activity in children and adolescents with type I diabetes is known to be associated with overnight hypoglycemia. We therefore wish to perform a prospective clinical study to assess the feasibility of using activity monitor data to adjust insulin pump basal rates and see whether we can help prevent overnight hypoglycemia or decrease related interventions following high activity days. We plan to carry this out by enrolling 20 subjects (10 subjects 1 to \<7 years old and 10 subjects 7 to 17 years old) with type 1 diabetes managed on insulin pump therapy and having them wear activity monitors and CGMs for up to 3 months. After an initial two-week period to establish activity baselines, we will recommend nighttime basal insulin rate adjustments based on activity monitor, CGM and insulin pump data.
Key facts
- Study ID
- NCT02299479
- Run by
- Boston Children's Hospital
- People needed
- 20
- Starts
- 2015-07-01
- Expected to finish
- 2017-06-27
- Last updated by the study team
- 2020-01-09
Who can join
Age: 1 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Type 1 diabetes (as clinically diagnosed by outpatient endocrinologist).
- Treated with insulin pump therapy for greater than or equal 6 months
- HbA1C of <8.5% in the previous 3 months
- Families will need to have access to Wi-Fi and a compatible smartphone in order for the data from the activity monitor and other devices to be transmitted to the research team
You may not qualify if…
- Current oral steroid use or other medication known to affect insulin action at investigator's discretion.
- **Note: currently only enrolling patients followed at Boston Children's Hospital
Where it is running
- Boston Children's Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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