Diabetes Care Transformation: Diabetes Data Registry and Intensive Remote Monitoring

NCT02596204 | Completed

• 1 other identifier: 1506-073
• Study Type: interventional
• Target: 113
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Change in Hemoglobin A1c

  Change in HbA1c from baseline to 6 months

  From baseline to 6 months

Secondary Outcomes (6)

• Health care utilization

  6 months

• PedsQL Inventory (PedsQL)

  6 months

• Diabetes Family Conflict Scale (DFCS)

  6 months

• Center for Epidemiology Scale- Depression (CES-D) survey

  6 months

• Problem Areas in Diabetes (PAID) survey

  6 months

Study Arms (2)

Data Upload

ACTIVE COMPARATOR

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. Subjects will continue to receive usual diabetes care. Phone calls and emails to the diabetes clinic will be initiated by the family.

Device: FitBit

Weekly Review

EXPERIMENTAL

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 (diabetes educator, nurse practitioner and/or physician) 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.

Other: Weekly Review; Device: FitBit

Interventions

Weekly Review OTHER

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.

Weekly Review

FitBit DEVICE

All subjects will wear a FitBit activity monitor.

Data Upload; Weekly Review

Eligibility Criteria

• Age: 8 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Type 1 diabetes, using an insulin pump (Medtronic, Omnipod, Animas)
• Duration of diabetes \>1 year
• Age: 8-17 years of age, inclusive.
• Hemoglobin A1c 8.0-10.0% at baseline visit, inclusive.
• Seen in the McNeely Diabetes Clinic within the past 6 months.
• The family/child is testing blood glucose at least 4 times a day.
• The family has a smart phone and service.

You may not qualify if:

• The child is not using insulin for management of diabetes.
• The child uses multiple daily injections of insulin.
• The child is unwilling to use the wearable device, or the family is unwilling or unable to upload glucose and insulin data on a routine basis
• The family is unwilling or unable to upload data from devices such as meter, pump, sensor, wearable device.
• Diagnosis of a mental health disorder.
• Parent/child does not speak English as the device software is only available in English.

Sponsors & Collaborators

• Children's Hospitals and Clinics of Minnesota: lead
• UnitedHealth Group: collaborator

Study Sites (1)

Children's Hospitals and Clinics of Minnesota

Saint Paul, Minnesota, 55102, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2015
• First Posted: November 4, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: August 1, 2017

Record last verified: 2017-07

Locations

US (1)