Clinical trial NCT02596204: Diabetes Care Transformation: Diabetes Data Registry and Intensive Remote Monitoring
Official title: Diabetes Care Transformation: Diabetes Data Registry and Intensive Remote Monitoring
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Lead sponsor: Children's Hospitals and Clinics of Minnesota
Sponsor class: OTHER
Collaborators: name: UnitedHealth Group
First posted: 2015-11-04
Enrollment: 113
Sex: ALL
Minimum age (years): 8
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change in Hemoglobin A1c
timeFrame: From baseline to 6 months
Secondary outcomes:
measure: Health care utilization
timeFrame: 6 months
measure: PedsQL Inventory (PedsQL)
timeFrame: 6 months
measure: Diabetes Family Conflict Scale (DFCS)
timeFrame: 6 months
measure: Center for Epidemiology Scale- Depression (CES-D) survey
timeFrame: 6 months
measure: Problem Areas in Diabetes (PAID) survey
timeFrame: 6 months
measure: Change in Hemoglobin A1c
timeFrame: Change from 6 months to 9 months
Other outcomes:
Locations:
city: Saint Paul
country: United States
facility: Children's Hospitals and Clinics of Minnesota
state: Minnesota
Study officials:
References: