Adjusting Insulin Delivery to Activity

NCT02299479 | Completed Results

• 1 other identifier: IRB-P00014511
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes; Nocturnal Hypoglycemia

Keywords

insulin pump; continuous glucose monitor; activity monitor

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Supplemental Carbohydrate Interventions up to 3 Months From Baseline.

  Median and inter-quartile range (IQR) of supplemental carbohydrate (SC) interventions (number of SC given by parent divided by the number of days the SC were given) to prevent hypoglycemia during the study period will be compared to those given during the baseline period for each subject. The median and IQR of all subjects will then be calculated.

  Up to 3 months

Secondary Outcomes (2)

• Correlation of Daytime Activity With Nighttime Nadir Glucose.

  Up to 3 months

• Change From Baseline in Supplemental Carbohydrate Interventions up to 3 Months From Baseline in Subjects With Activity Effect.

  Up to 3 months

Study Arms (1)

Intervention

EXPERIMENTAL

Volunteers will wear a Dexcom G4 Platinum CGM device as well as an activity monitor. Data will be uploaded to study investigators on a regular basis, and recommendations will be made to adjust insulin dosing based upon analysis of these data.

Device: Dexcom G4 Platinum CGM; Device: Activity monitor

Interventions

Dexcom G4 Platinum CGM DEVICE

Blood glucose levels will be monitored using continuous glucose monitors (CGMs). Participants will be asked to verify CGM low blood sugars using their home glucometer. Insulin dose adjustments will be made if there is concern that nocturnal hypoglycemia is occurring in relation to high daytime activity.

Also known as: Continuous glucose monitor and activity monitor

Intervention

Activity monitor DEVICE

Participants will be asked to wear an activity monitor so that we may assess their daily activity level. Insulin dose adjustments will be made if there is concern that nocturnal hypoglycemia is occurring in relation to high daytime activity.

Intervention

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

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

Sponsors & Collaborators

• Boston Children's Hospital: lead

Study Sites (1)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Related Publications (4)

• 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.

  PMID: 24671945 BACKGROUND

• 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.

  PMID: 24351189 BACKGROUND

• 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.

  PMID: 22957521 BACKGROUND

• 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.

  PMID: 23033237 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus

Interventions

Fitness Trackers

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies; Wearable Electronic Devices; Electrical Equipment and Supplies

Results Point of Contact

• Title: Garry Steil, PhD
• Organization: Boston Children's Hospital

Garry.Steil@childrens.harvard.edu

617 355-6000

Study Officials

• Michael Agus, MD

  Boston Children's Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 20, 2014
• First Posted: November 24, 2014
• Study Start: July 1, 2015
• Primary Completion: June 27, 2017
• Study Completion: June 27, 2017
• Last Updated: January 9, 2020
• Results First Posted: December 28, 2018

Record last verified: 2020-01

Locations

US (1)