Diabetes Care Transformation: Diabetes Data Registry and Intensive Remote Monitoring

Type 1 Diabetes Mellitus Clinical Trial

— DCT1A  

Official title:

Diabetes Care Transformation: Diabetes Data Registry and Intensive Remote Monitoring

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02596204
• Other study ID #: 1506-073
• Status: Completed
• Phase: N/A
• First received: October 5, 2015
• Last updated: July 28, 2017
• Start date: September 2015
• Est. completion date: December 2016

Study information

• Verified date: July 2017
• Source: Children's Hospitals and Clinics of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 8 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

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.

Locations

Country	Name	City	State
United States	Children's Hospitals and Clinics of Minnesota	Saint Paul	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Children's Hospitals and Clinics of Minnesota	UnitedHealth Group

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Hemoglobin A1c	Change in HbA1c from baseline to 6 months	From baseline to 6 months
Secondary	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	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	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.	6 months
Secondary	Change in Hemoglobin A1c	Change in hemoglobin A1c from 6 months (end of active intervention) to 9 months	Change from 6 months to 9 months