N/A
Completed N=20
Adjusting Insulin Delivery to Activity
Diabetes · Nocturnal Hypoglycemia
Source: ClinicalTrials.gov NCT02299479 ↗
Enrolled (actual)
20
Serious AEs
0.0%
Results posted
Dec 2018
Primary outcomePrimary: Change From Baseline in Supplemental Carbohydrate Interventions up to 3 Months From Baseline. — 0.11 Supplemental Carb (SC) admin. per night
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Supplemental Carbohydrate Interventions up to 3 Months From Baseline. |
0.11 | — |
| SECONDARY Correlation of Daytime Activity With Nighttime Nadir Glucose. |
0.10 | — |
| SECONDARY Change From Baseline in Supplemental Carbohydrate Interventions up to 3 Months From Baseline in Subjects With Activity Effect. |
— | — |
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT02299479). 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.