NCT02596204

Diabetes Care Transformation: Diabetes Data Registry and Intensive Remote Monitoring

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 113 (actual)
• Sponsor: Children's Hospitals and Clinics of Minnesota · Academic / Other
• Sex: All
• Age: 8 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

With emerging mobile technology, sharing glucose, insulin and sensor data with the clinic for frequent and timely monitoring is now feasible. The investigators propose to leverage this new technology to provide children and families with appropriate interventions to help manage their diabetes.

Detailed description

The investigators will collect insulin dosing via pump records, blood glucose meter, continuous glucose sensor, activity, heart rate, and sleep data on a weekly basis from 100 children with diabetes. The investigators hypothesize that with the collection and analysis of insulin, blood glucose, sensor, activity, heart rate and sleep data in children with diabetes the investigators can identify glucose patterns and predictors of acute events. The 100 children will be randomized to either conventional therapy (data upload group) or intensive remote therapy (weekly review group). Conventional therapy will consist of routine quarterly visits to the clinic and as-needed communication with the diabetes staff, initiated by the family, between study visits. Intensive remote therapy will consist of routine quarterly visits to the clinic along with weekly remote review of insulin and blood glucose data by the research staff, and additional communication with the family, initiated by the diabetes staff as needed, between visits. The investigators hypothesize that with weekly, manual review of real-time insulin, glucose, and activity data in children with diabetes, and recommended regimen changes based on the data, the investigators will be able to lower HbA1c values in children in the weekly review group as compared to children in the data upload group.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
OTHER	Weekly Review	Subjects will wear a FitBit activity monitor and continue to use their insulin pump. Fitbit, pump and sensor (if applicable) data will be uploaded at least weekly. For subjects in the weekly review group, research staff (CDE, NP and/or MD) will review uploaded blood glucose, pump, and available sensor, activity and sleep data on a weekly basis. If glucose patterns are identified which suggest a change to diabetes management (ie insulin dose changes), the family will be contacted by text, email or telephone to review glucose patterns and to review staff recommendations.
DEVICE	FitBit	All subjects will wear a FitBit activity monitor.

Timeline

• Start date: 2015-09-01
• Primary completion: 2016-12-01
• Completion: 2016-12-01
• First posted: 2015-11-04
• Last updated: 2017-08-01

Locations

1 site across 1 country: United States