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).
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Enrollment
132
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.
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.
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, United States
Family Communication Inventory Questionnaire
It is hypothesized that individuals randomized to the Control Group will initially modestly improve management as a result of either of new access to CGM, but it will return to baseline levels by the 12-week evaluation. By contrast, it is hypothesize that individuals randomized to the Experimental Group will benefit from receiving the weekly CloudConnect Report by having increased engagement and communication by 8 weeks that is sustained by 12 weeks (3 months). The communication will be measured by comparing pre- and post-study Family Communication Inventory questionnaire and the weekly communication assessments. The Family Communication Inventory, Frequency scale assesses the amount of times a parent and adolescent communicate regarding insulin dosing. Scores range from 0 to 36, with higher scores reflecting more frequent communication--commonly thought of as a better outcome.
Time frame: 12-weeks
Glucose Time in Range 70-180 mg/dL, Overall
Percentage of time during the study with glucose value between 70-180 mg/dL as measured by continuous glucose monitor, CGM
Time frame: Overall (12 weeks)
HbA1c, Final
Final HbA1c measure
Time frame: 12-week
Mean Glucose by CGM
Average glucose level measured by CGM
Time frame: 12-week
Percent Time <70 mg/dL
Percentage of time participant spent with blood glucose below 70 mg/dL
Time frame: 12-week
Percent Time >180 mg/dL
Percentage of time participant spent with blood glucose greater than 180 mg/dL
Time frame: 12-week
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Low Blood Glucose Episodes Per Week
The number of episodes of hypoglycemia experienced each week
Time frame: 12-week
Family Conflict Scale
Score on the survey entitled Family Conflict Scale, which assesses the amount of Type 1 diabetes-related conflict between an adolescent and parent. Scores range from 19 to 57, with higher scores reflecting a greater amount of conflict--a worse outcome.
Time frame: 12-week
Division of Diabetes Responsibilities Score
Adolescents completed the Division of Diabetes Responsibilities survey assessing their degree of responsibilities for given Type 1 diabetes management tasks, with scores ranging from 6 to 30 and with higher scores representing the adolescent assuming more responsibilities--commonly thought of as a better outcome.
Time frame: 12-week
Child Self Management Score
Scores on the Child Self Management are an assessment of the frequency over the past week of omitting T1D-related tasks for insulin dosing, with scores ranging from 0 to 30 and with higher scores representing more missed T1D-related tasks--commonly thought of as a worse outcome.
Time frame: 12-week
My-Q
Adolescent responses to My-Q relate to Type 1 diabetes-related quality of life, with scores ranging from 27-135 and with higher scores indicating a higher quality of life--a better outcome.
Time frame: 12-week
Weekly Diabetes Communication
Adolescent response to the question: "During the past week, did you talk with your parents about your diabetes management?"
Time frame: 12-week
Tone of Response
Adolescent rating Tone of response, i.e. whether Type 1 diabetes-specific communication has an overall positive or negative tone; scores ranged from 1 to 5, with 1 being a very negative tone and 5 being a very positive tone--a better outcome.
Time frame: 12-week
Change of Insulin Parameters
Adolescent responding to the question, "During the past week, did you change your insulin parameters?"
Time frame: 12-week