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Completed

NCT Number: NCT02596204

Diabetes Care Transformation: Diabetes Data Registry and Intensive Remote Monitoring

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.

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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Nutritional and Metabolic Diseases

Age range

8 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Children's Hospitals and Clinics of Minnesota

Saint Paul, Minnesota, 55102, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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.

Fitbit

Device

All subjects will wear a FitBit activity monitor.

Primary outcomes

  1. Change in Hemoglobin A1c

    Time frame: From baseline to 6 months

    Change in HbA1c from baseline to 6 months

Secondary outcomes

  1. Health care utilization

    Time frame: 6 months

    The investigators will track the number of phone calls to clinic, emergency department visits and hospitalizations over 6 months between data upload and weekly review groups

  2. PedsQL Inventory (PedsQL)

    Time frame: 6 months

    The investigators will assess change in the PedsQL (Peds Quality of Life) Inventory from baseline to 6 months between data upload and weekly review groups.

  3. Diabetes Family Conflict Scale (DFCS)

    Time frame: 6 months

    The investigators will assess change in the Diabetes Family Conflict Scale from baseline to 6 months between data upload and weekly review groups.

  4. Center for Epidemiology Scale- Depression (CES-D) survey

    Time frame: 6 months

    The investigators will assess change in the Center for Epidemiology Scale- Depression from baseline to 6 months between data upload and weekly review groups.

  5. Problem Areas in Diabetes (PAID) survey

    Time frame: 6 months

    The investigators will assess change in the Problem Areas in Diabetes- pediatrics and Problem Areas in Diabetes- parent from baseline to 6 months between data upload and weekly review groups.

  6. Change in Hemoglobin A1c

    Time frame: Change from 6 months to 9 months

    Change in hemoglobin A1c from 6 months (end of active intervention) to 9 months

Sponsors and collaborators

Lead sponsor

Children's Hospitals and Clinics of Minnesota

Other

Collaborators

  • UnitedHealth Group

Registry information

Acronym: DCT1A

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 4, 2015
Registry last updated
Aug 1, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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