Effects of a Remote Patient Monitoring Protocol on Glycemic Control in Adolescents with Type 1 Diabetes
Study ID: STU 122016-056
This study will use a randomized, crossover design. Children aged 13-18 years who have been diagnosed with Type 1 diabetes for at least 1 year and with at least 2 Hemoglobin a1c values [GreaterThanorequalTo]10.0% more than 60 days apart within the past year, with the most recent Hba1c value between 10-14%, will be placed into two separate treatment groups. Group a will undergo home monitoring for 12 weeks through the use of the Vivify kit, which contains a wireless tablet with daily medication/diet/symptom questionnaires and home glucose monitoring. Group B will initially continue diabetes management per standard of care, including quarterly office visits. after a period of 12 weeks, Group B will switch to the RPM protocol, while Group a will return to standard of care. Both groups will have Hba1c values checked at the 0, 3, and 6 month time periods to assess the effect of the remote monitoring protocol. Participation in the RPM protocol will involve twice a day uploads of blood glucose values and daily completion of the Care Plan questions, as well as weekly uploads of blood glucose values using the Glooko, inc (Mountain View, Ca) application, and weekly video visits with a member of the endocrinology team that will aim to address barriers to optimal care, whether they be motivation, knowledge or other difficulties. Barriers to care will be assessed in part through the completion of knowledge and self-efficacy assessments.
* Age 13-18 years old * Diagnosed with Type 1 Diabetes Mellitus >1 year ago with at least one positive diabetes autoantibody * Patient on multiple daily injections of insulin, with no change to insulin type within the past 3 months * >=2 separate HbA1c values (at least 60 days apart) >=10.0% in the past year, with the most recent HbA1c value between 10-14% * English-Speaking (patient and at least 1 parent) * Patient or parents must own a smart phone or other device compatible with Glooko