Type 1 Diabetes Mellitus
Conditions
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.
Interventions
OTHERWeekly 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.
DEVICEFitBit
All subjects will wear a FitBit activity monitor.
Sponsors
UnitedHealth Group
Children's Hospitals and Clinics of Minnesota
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 17 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hemoglobin A1c | From baseline to 6 months | Change in HbA1c from baseline to 6 months |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PedsQL Inventory (PedsQL) | 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. |
| Diabetes Family Conflict Scale (DFCS) | 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. |
| Health care utilization | 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 |
| Problem Areas in Diabetes (PAID) survey | 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. |
| Change in Hemoglobin A1c | Change from 6 months to 9 months | Change in hemoglobin A1c from 6 months (end of active intervention) to 9 months |
| Center for Epidemiology Scale- Depression (CES-D) survey | 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. |
Countries
United States
Outcome results
None listed