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Diabetes Care Transformation: Diabetes Data Registry and Intensive Remote Monitoring

NCT02596204 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 113

Last updated 2017-08-01

No results posted yet for this study

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.

Conditions

  • Type 1 Diabetes Mellitus

Interventions

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.

Sponsors & Collaborators

  • UnitedHealth Group

    collaborator INDUSTRY

  • Children's Hospitals and Clinics of Minnesota

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-09-30
Primary Completion
2016-12-31
Completion
2016-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02596204 on ClinicalTrials.gov