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Diabetes Care Transformation: Diabetes Data Registry and Intensive Remote Monitoring (DCT1A)

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Weekly Review
FitBit
Sponsored by
Children's Hospitals and Clinics of Minnesota
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus

Eligibility Criteria

8 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  1. The child is not using insulin for management of diabetes.
  2. The child uses multiple daily injections of insulin.
  3. 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
  4. The family is unwilling or unable to upload data from devices such as meter, pump, sensor, wearable device.
  5. Diagnosis of a mental health disorder.
  6. Parent/child does not speak English as the device software is only available in English.

Sites / Locations

  • Children's Hospitals and Clinics of Minnesota

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Data Upload

Weekly Review

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change in Hemoglobin A1c
Change in HbA1c from baseline to 6 months

Secondary Outcome Measures

Health care utilization
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
PedsQL Inventory (PedsQL)
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.
Diabetes Family Conflict Scale (DFCS)
The investigators will assess change in the Diabetes Family Conflict Scale from baseline to 6 months between data upload and weekly review groups.
Center for Epidemiology Scale- Depression (CES-D) survey
The investigators will assess change in the Center for Epidemiology Scale- Depression from baseline to 6 months between data upload and weekly review groups.
Problem Areas in Diabetes (PAID) survey
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.
Change in Hemoglobin A1c
Change in hemoglobin A1c from 6 months (end of active intervention) to 9 months

Full Information

First Posted
October 5, 2015
Last Updated
July 28, 2017
Sponsor
Children's Hospitals and Clinics of Minnesota
Collaborators
UnitedHealth Group
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1. Study Identification

Unique Protocol Identification Number
NCT02596204
Brief Title
Diabetes Care Transformation: Diabetes Data Registry and Intensive Remote Monitoring
Acronym
DCT1A
Official Title
Diabetes Care Transformation: Diabetes Data Registry and Intensive Remote Monitoring
Study Type
Interventional

2. Study Status

Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
December 2016 (Actual)
Study Completion Date
December 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Children's Hospitals and Clinics of Minnesota
Collaborators
UnitedHealth Group

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
113 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Data Upload
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Weekly Review
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Weekly Review
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
FitBit
Intervention Description
All subjects will wear a FitBit activity monitor.
Primary Outcome Measure Information:
Title
Change in Hemoglobin A1c
Description
Change in HbA1c from baseline to 6 months
Time Frame
From baseline to 6 months
Secondary Outcome Measure Information:
Title
Health care utilization
Description
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
Time Frame
6 months
Title
PedsQL Inventory (PedsQL)
Description
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.
Time Frame
6 months
Title
Diabetes Family Conflict Scale (DFCS)
Description
The investigators will assess change in the Diabetes Family Conflict Scale from baseline to 6 months between data upload and weekly review groups.
Time Frame
6 months
Title
Center for Epidemiology Scale- Depression (CES-D) survey
Description
The investigators will assess change in the Center for Epidemiology Scale- Depression from baseline to 6 months between data upload and weekly review groups.
Time Frame
6 months
Title
Problem Areas in Diabetes (PAID) survey
Description
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.
Time Frame
6 months
Title
Change in Hemoglobin A1c
Description
Change in hemoglobin A1c from 6 months (end of active intervention) to 9 months
Time Frame
Change from 6 months to 9 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Children's Hospitals and Clinics of Minnesota
City
Saint Paul
State/Province
Minnesota
ZIP/Postal Code
55102
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Diabetes Care Transformation: Diabetes Data Registry and Intensive Remote Monitoring

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