NCT03676465

CloudConnect: Predictive And Retrospective Clinical Decision Support For Chronic Disease Management

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 132 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 12 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This study is to assess an approach of self-management called CloudConnect, evaluating the impact of CloudConnect Reports on patient engagement, adolescent/parent discussion, and clinical outcomes in adolescent Type 1 Diabetes (T1D).

Detailed description

It is hypothesized that in contrast to adolescents randomized to the Control Group subjects will maintain a Hemoglobin A1c (HbA1c) while adolescents randomized to receiving the CloudConnect Report will have a lowering of HbA1c that is related to the increase in adolescent/parent disease-specific engagement. Moreover, the hypothesis is that the subjects receiving the CloudConnect Report will increase the engagement of adolescents/ parent through increased communication and self-management behavior, and that this increase in engagement will lead to improved medical outcomes.

Conditions

• Type 1 Diabetes Mellitus

Interventions

Type	Name	Description
OTHER	CloudConnect Report	Subjects and their parents will be asked to download the data from the study devices as well as download their insulin pump/pen. The participants will receive a weekly CloudConnect Report that is based on analysis of the data gathered from the downloads provided by the subject during that week. Participants will both receive weekly contact from the study team to discuss the communication that the subject \& their parent had during the week about the participant's diabetes management.
OTHER	Will not receive a CloudConnect Report	Subjects and their parents will be asked to download the data from the study devices as well as download their insulin pump/pen. Participants will receive weekly contact from the study team to discuss the communication that the subject \& their parent had during the week about the participant's diabetes management.

Timeline

• Start date: 2019-01-18
• Primary completion: 2021-02-02
• Completion: 2021-02-02
• First posted: 2018-09-18
• Last updated: 2023-12-19
• Results posted: 2023-12-19

Locations

1 site across 1 country: United States