Clinical trial NCT02299479: Adjusting Insulin Delivery to Activity
Official title: Adjusting Insulin Delivery to Activity (AIDA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Nocturnal Hypoglycemia
Keywords: insulin pump
continuous glucose monitor
activity monitor
Lead sponsor: Boston Children's Hospital
Sponsor class: OTHER
First posted: 2014-11-24
Enrollment: 20
Sex: ALL
Minimum age (years): 1
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

Brief 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.

Detailed description: This study is a pilot trial investigating the feasibility of using activity monitoring data to adjust insulin pump therapy and prevent hypoglycemia. The study will enroll 20 patients with type 1 diabetes mellitus on insulin pump therapy, 10 from each of two age groups: younger children aged 1 year to \<7 years of age, and older children aged 7-17 years of age. Subjects will be provided with continuous glucose monitors (DexCom G4) and activity monitors. Study duration will be up to 3 months. During the course of the study patients will continue to receive routine care by their primary endocrinologist and diabetes nurse educator (DNE). Insulin dose adjustments unrelated to activity monitor data will continue to be at the discretion of the patient's primary diabetes team.

Activity level (steps and calories burned) will be uploaded over the web in a secure fashion to our central firewall-protected database on a daily basis while CGM glucose values and insulin pump data will be collected once a week. The initial 2 weeks of a subject's enrollment in the study will be used to establish his or her baseline activity level and no changes to the insulin regimen will be made based on the activity monitor data. During weeks 3 to 12, activity data will be reviewed daily and an alternate basal insulin rate will be recommended on days considered to be increased activity days. We will use an adaptive algorithm to help guide suggested insulin basal rate changes. All recommendations will be reviewed and approved by a physician prior to implementation. The alternate rate will be derived using the subject's usual care pump settings as an initial starting point from which to make incremental changes in the 3 hour interval leading up to the hypoglycemic event. Target will be the overnight nadir obtained with usual care settings. Residual error (CGM-target) will be used to assess the validity of using the 3 hour window prior to the event to effect lower basal.

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

Primary outcomes:
measure: Change From Baseline in Supplemental Carbohydrate Interventions up to 3 Months From Baseline.
timeFrame: Up to 3 months
Secondary outcomes:
measure: Correlation of Daytime Activity With Nighttime Nadir Glucose.
timeFrame: Up to 3 months
measure: Change From Baseline in Supplemental Carbohydrate Interventions up to 3 Months From Baseline in Subjects With Activity Effect.
timeFrame: Up to 3 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
Study officials:
affiliation: Boston Children's Hospital
name: Michael Agus, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Agus MS, Asaro LA, Steil GM, Alexander JL, Silverman M, Wypij D, Gaies MG; SPECS Investigators. Tight glycemic control after pediatric cardiac surgery in high-risk patient populations: a secondary analysis of the safe pediatric euglycemia after cardiac surgery trial. Circulation. 2014 Jun 3;129(22):2297-304. doi: 10.1161/CIRCULATIONAHA.113.008124. Epub 2014 Mar 26.
citation: Steil GM. Algorithms for a closed-loop artificial pancreas: the case for proportional-integral-derivative control. J Diabetes Sci Technol. 2013 Nov 1;7(6):1621-31. doi: 10.1177/193229681300700623.
citation: Agus MS, Steil GM, Wypij D, Costello JM, Laussen PC, Langer M, Alexander JL, Scoppettuolo LA, Pigula FA, Charpie JR, Ohye RG, Gaies MG; SPECS Study Investigators. Tight glycemic control versus standard care after pediatric cardiac surgery. N Engl J Med. 2012 Sep 27;367(13):1208-19. doi: 10.1056/NEJMoa1206044. Epub 2012 Sep 7.
citation: Dauber A, Corcia L, Safer J, Agus MS, Einis S, Steil GM. Closed-loop insulin therapy improves glycemic control in children aged <7 years: a randomized controlled trial. Diabetes Care. 2013 Feb;36(2):222-7. doi: 10.2337/dc12-1079. Epub 2012 Oct 1.