Trial Outcomes & Findings for CloudConnect: Predictive And Retrospective Clinical Decision Support For Chronic Disease Management (NCT NCT03676465)
NCT ID: NCT03676465
Last Updated: 2023-12-19
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
132 participants
Primary outcome timeframe
12-weeks
Results posted on
2023-12-19
Participant Flow
From to 18 January 2019 to 13 January 2021, we a total of 132 participants (66 adolescent+parent dyads, each counted separately as participants) signed consent. Participants were recruited from the UVa Center for Diabetes Technology database and local Pediatric Endocrinology clinics.
38 participants (19 adolescent+parent dyads) dropped out prior to randomization.
Unit of analysis: adolescent+parent dyad
Participant milestones
| Measure |
Experimental Group
Subjects will wear their personal pump (if appropriate), use a study insulin pen (if appropriate), a study CGM and study activity tracker (i.e. Fitbit). Participants will receive a weekly CloudConnect Report based on analysis of the weekly data gathered for each participant. The report will be sent via email once a week to both the subject and their parent(s). Subjects and parents will have weekly contact with the study team. Subjects will complete questionnaires at the beginning and end of the study. These questionnaires will ask subjects about:
* the communication within the family about the information shared in this report
* how subjects feel when blood sugar is high or low
* who takes responsibility of how diabetes care is managed
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.
|
Control Group
Subjects will wear their personal pump (if appropriate), use a study insulin pen (if appropriate), a study CGM and study activity tracker (i.e. Fitbit). Participants will not receive a CloudConnect Report. Subjects and parents will have weekly contact with the study team. Subjects will complete questionnaires at the beginning and end of the study. These questionnaires will ask subjects about:
* the communication within the family about the information shared in this report
* how subjects feel when blood sugar is high or low
* who takes responsibility of how diabetes care is managed
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.
|
|---|---|---|
|
Overall Study
STARTED
|
42 21
|
52 26
|
|
Overall Study
COMPLETED
|
42 21
|
44 22
|
|
Overall Study
NOT COMPLETED
|
0 0
|
8 4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
CloudConnect: Predictive And Retrospective Clinical Decision Support For Chronic Disease Management
Baseline characteristics by cohort
| Measure |
Experimental Group
n=21 Participants
Subjects will wear their personal pump (if appropriate), use a study insulin pen (if appropriate), a study CGM and study activity tracker (i.e. Fitbit). Participants will receive a weekly CloudConnect Report based on analysis of the weekly data gathered for each participant. The report will be sent via email once a week to both the subject and their parent(s). Subjects and parents will have weekly contact with the study team. Subjects will complete questionnaires at the beginning and end of the study. These questionnaires will ask subjects about:
* the communication within the family about the information shared in this report
* how subjects feel when blood sugar is high or low
* who takes responsibility of how diabetes care is managed
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.
|
Control Group
n=22 Participants
Subjects will wear their personal pump (if appropriate), use a study insulin pen (if appropriate), a study CGM and study activity tracker (i.e. Fitbit). Participants will not receive a CloudConnect Report. Subjects and parents will have weekly contact with the study team. Subjects will complete questionnaires at the beginning and end of the study. These questionnaires will ask subjects about:
* the communication within the family about the information shared in this report
* how subjects feel when blood sugar is high or low
* who takes responsibility of how diabetes care is managed
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.
|
Total
n=43 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
21 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
14.8 years
STANDARD_DEVIATION 1.5 • n=5 Participants
|
14.8 years
STANDARD_DEVIATION 1.8 • n=7 Participants
|
14.8 years
STANDARD_DEVIATION 1.7 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
41 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
21 adolescents
n=5 Participants
|
22 adolescents
n=7 Participants
|
43 adolescents
n=5 Participants
|
|
Family Communication Inventory, Frequency scale
|
12.0 units on a scale: FCI, Frequency
STANDARD_DEVIATION 4.8 • n=5 Participants
|
12.2 units on a scale: FCI, Frequency
STANDARD_DEVIATION 7.3 • n=7 Participants
|
12.1 units on a scale: FCI, Frequency
STANDARD_DEVIATION 6.2 • n=5 Participants
|
PRIMARY outcome
Timeframe: 12-weeksIt 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.
Outcome measures
| Measure |
Experimental Group
n=21 Participants
Subjects will wear their personal pump (if appropriate), use a study insulin pen (if appropriate), a study CGM and study activity tracker (i.e. Fitbit). Participants will receive a weekly CloudConnect Report based on analysis of the weekly data gathered for each participant. The report will be sent via email once a week to both the subject and their parent(s). Subjects and parents will have weekly contact with the study team. Subjects will complete questionnaires at the beginning and end of the study. These questionnaires will ask subjects about:
* the communication within the family about the information shared in this report
* how subjects feel when blood sugar is high or low
* who takes responsibility of how diabetes care is managed
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.
|
Control Group
n=22 Participants
Subjects will wear their personal pump (if appropriate), use a study insulin pen (if appropriate), a study CGM and study activity tracker (i.e. Fitbit). Participants will not receive a CloudConnect Report. Subjects and parents will have weekly contact with the study team. Subjects will complete questionnaires at the beginning and end of the study. These questionnaires will ask subjects about:
* the communication within the family about the information shared in this report
* how subjects feel when blood sugar is high or low
* who takes responsibility of how diabetes care is managed
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.
|
|---|---|---|
|
Family Communication Inventory Questionnaire
|
12.3 Score on a scale
Standard Deviation 3.8
|
11.5 Score on a scale
Standard Deviation 6.7
|
SECONDARY outcome
Timeframe: Overall (12 weeks)Percentage of time during the study with glucose value between 70-180 mg/dL as measured by continuous glucose monitor, CGM
Outcome measures
| Measure |
Experimental Group
n=21 Participants
Subjects will wear their personal pump (if appropriate), use a study insulin pen (if appropriate), a study CGM and study activity tracker (i.e. Fitbit). Participants will receive a weekly CloudConnect Report based on analysis of the weekly data gathered for each participant. The report will be sent via email once a week to both the subject and their parent(s). Subjects and parents will have weekly contact with the study team. Subjects will complete questionnaires at the beginning and end of the study. These questionnaires will ask subjects about:
* the communication within the family about the information shared in this report
* how subjects feel when blood sugar is high or low
* who takes responsibility of how diabetes care is managed
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.
|
Control Group
n=22 Participants
Subjects will wear their personal pump (if appropriate), use a study insulin pen (if appropriate), a study CGM and study activity tracker (i.e. Fitbit). Participants will not receive a CloudConnect Report. Subjects and parents will have weekly contact with the study team. Subjects will complete questionnaires at the beginning and end of the study. These questionnaires will ask subjects about:
* the communication within the family about the information shared in this report
* how subjects feel when blood sugar is high or low
* who takes responsibility of how diabetes care is managed
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.
|
|---|---|---|
|
Glucose Time in Range 70-180 mg/dL, Overall
|
47.6 percentage of time in range 70-180 mg/dL
Standard Deviation 12.7
|
40.4 percentage of time in range 70-180 mg/dL
Standard Deviation 7.5
|
SECONDARY outcome
Timeframe: 12-weekFinal HbA1c measure
Outcome measures
| Measure |
Experimental Group
n=21 Participants
Subjects will wear their personal pump (if appropriate), use a study insulin pen (if appropriate), a study CGM and study activity tracker (i.e. Fitbit). Participants will receive a weekly CloudConnect Report based on analysis of the weekly data gathered for each participant. The report will be sent via email once a week to both the subject and their parent(s). Subjects and parents will have weekly contact with the study team. Subjects will complete questionnaires at the beginning and end of the study. These questionnaires will ask subjects about:
* the communication within the family about the information shared in this report
* how subjects feel when blood sugar is high or low
* who takes responsibility of how diabetes care is managed
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.
|
Control Group
n=22 Participants
Subjects will wear their personal pump (if appropriate), use a study insulin pen (if appropriate), a study CGM and study activity tracker (i.e. Fitbit). Participants will not receive a CloudConnect Report. Subjects and parents will have weekly contact with the study team. Subjects will complete questionnaires at the beginning and end of the study. These questionnaires will ask subjects about:
* the communication within the family about the information shared in this report
* how subjects feel when blood sugar is high or low
* who takes responsibility of how diabetes care is managed
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.
|
|---|---|---|
|
HbA1c, Final
|
7.58 % of Hb
Standard Deviation 0.94
|
7.71 % of Hb
Standard Deviation 1.11
|
SECONDARY outcome
Timeframe: 12-weekAverage glucose level measured by CGM
Outcome measures
| Measure |
Experimental Group
n=21 Participants
Subjects will wear their personal pump (if appropriate), use a study insulin pen (if appropriate), a study CGM and study activity tracker (i.e. Fitbit). Participants will receive a weekly CloudConnect Report based on analysis of the weekly data gathered for each participant. The report will be sent via email once a week to both the subject and their parent(s). Subjects and parents will have weekly contact with the study team. Subjects will complete questionnaires at the beginning and end of the study. These questionnaires will ask subjects about:
* the communication within the family about the information shared in this report
* how subjects feel when blood sugar is high or low
* who takes responsibility of how diabetes care is managed
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.
|
Control Group
n=22 Participants
Subjects will wear their personal pump (if appropriate), use a study insulin pen (if appropriate), a study CGM and study activity tracker (i.e. Fitbit). Participants will not receive a CloudConnect Report. Subjects and parents will have weekly contact with the study team. Subjects will complete questionnaires at the beginning and end of the study. These questionnaires will ask subjects about:
* the communication within the family about the information shared in this report
* how subjects feel when blood sugar is high or low
* who takes responsibility of how diabetes care is managed
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.
|
|---|---|---|
|
Mean Glucose by CGM
|
198.2 mg/dL
Standard Deviation 28.2
|
201.0 mg/dL
Standard Deviation 27.6
|
SECONDARY outcome
Timeframe: 12-weekPercentage of time participant spent with blood glucose below 70 mg/dL
Outcome measures
| Measure |
Experimental Group
n=21 Participants
Subjects will wear their personal pump (if appropriate), use a study insulin pen (if appropriate), a study CGM and study activity tracker (i.e. Fitbit). Participants will receive a weekly CloudConnect Report based on analysis of the weekly data gathered for each participant. The report will be sent via email once a week to both the subject and their parent(s). Subjects and parents will have weekly contact with the study team. Subjects will complete questionnaires at the beginning and end of the study. These questionnaires will ask subjects about:
* the communication within the family about the information shared in this report
* how subjects feel when blood sugar is high or low
* who takes responsibility of how diabetes care is managed
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.
|
Control Group
n=22 Participants
Subjects will wear their personal pump (if appropriate), use a study insulin pen (if appropriate), a study CGM and study activity tracker (i.e. Fitbit). Participants will not receive a CloudConnect Report. Subjects and parents will have weekly contact with the study team. Subjects will complete questionnaires at the beginning and end of the study. These questionnaires will ask subjects about:
* the communication within the family about the information shared in this report
* how subjects feel when blood sugar is high or low
* who takes responsibility of how diabetes care is managed
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.
|
|---|---|---|
|
Percent Time <70 mg/dL
|
1.1 % of time
Interval 0.6 to 2.9
|
1.2 % of time
Interval 0.7 to 2.5
|
SECONDARY outcome
Timeframe: 12-weekPercentage of time participant spent with blood glucose greater than 180 mg/dL
Outcome measures
| Measure |
Experimental Group
n=21 Participants
Subjects will wear their personal pump (if appropriate), use a study insulin pen (if appropriate), a study CGM and study activity tracker (i.e. Fitbit). Participants will receive a weekly CloudConnect Report based on analysis of the weekly data gathered for each participant. The report will be sent via email once a week to both the subject and their parent(s). Subjects and parents will have weekly contact with the study team. Subjects will complete questionnaires at the beginning and end of the study. These questionnaires will ask subjects about:
* the communication within the family about the information shared in this report
* how subjects feel when blood sugar is high or low
* who takes responsibility of how diabetes care is managed
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.
|
Control Group
n=22 Participants
Subjects will wear their personal pump (if appropriate), use a study insulin pen (if appropriate), a study CGM and study activity tracker (i.e. Fitbit). Participants will not receive a CloudConnect Report. Subjects and parents will have weekly contact with the study team. Subjects will complete questionnaires at the beginning and end of the study. These questionnaires will ask subjects about:
* the communication within the family about the information shared in this report
* how subjects feel when blood sugar is high or low
* who takes responsibility of how diabetes care is managed
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.
|
|---|---|---|
|
Percent Time >180 mg/dL
|
53.6 % of time
Standard Deviation 12.8
|
54.0 % of time
Standard Deviation 12.8
|
SECONDARY outcome
Timeframe: 12-weekThe number of episodes of hypoglycemia experienced each week
Outcome measures
| Measure |
Experimental Group
n=21 Participants
Subjects will wear their personal pump (if appropriate), use a study insulin pen (if appropriate), a study CGM and study activity tracker (i.e. Fitbit). Participants will receive a weekly CloudConnect Report based on analysis of the weekly data gathered for each participant. The report will be sent via email once a week to both the subject and their parent(s). Subjects and parents will have weekly contact with the study team. Subjects will complete questionnaires at the beginning and end of the study. These questionnaires will ask subjects about:
* the communication within the family about the information shared in this report
* how subjects feel when blood sugar is high or low
* who takes responsibility of how diabetes care is managed
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.
|
Control Group
n=22 Participants
Subjects will wear their personal pump (if appropriate), use a study insulin pen (if appropriate), a study CGM and study activity tracker (i.e. Fitbit). Participants will not receive a CloudConnect Report. Subjects and parents will have weekly contact with the study team. Subjects will complete questionnaires at the beginning and end of the study. These questionnaires will ask subjects about:
* the communication within the family about the information shared in this report
* how subjects feel when blood sugar is high or low
* who takes responsibility of how diabetes care is managed
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.
|
|---|---|---|
|
Low Blood Glucose Episodes Per Week
|
2.75 episodes per week
Interval 1.8 to 6.35
|
3.3 episodes per week
Interval 1.2 to 5.3
|
SECONDARY outcome
Timeframe: 12-weekScore 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.
Outcome measures
| Measure |
Experimental Group
n=21 Participants
Subjects will wear their personal pump (if appropriate), use a study insulin pen (if appropriate), a study CGM and study activity tracker (i.e. Fitbit). Participants will receive a weekly CloudConnect Report based on analysis of the weekly data gathered for each participant. The report will be sent via email once a week to both the subject and their parent(s). Subjects and parents will have weekly contact with the study team. Subjects will complete questionnaires at the beginning and end of the study. These questionnaires will ask subjects about:
* the communication within the family about the information shared in this report
* how subjects feel when blood sugar is high or low
* who takes responsibility of how diabetes care is managed
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.
|
Control Group
n=22 Participants
Subjects will wear their personal pump (if appropriate), use a study insulin pen (if appropriate), a study CGM and study activity tracker (i.e. Fitbit). Participants will not receive a CloudConnect Report. Subjects and parents will have weekly contact with the study team. Subjects will complete questionnaires at the beginning and end of the study. These questionnaires will ask subjects about:
* the communication within the family about the information shared in this report
* how subjects feel when blood sugar is high or low
* who takes responsibility of how diabetes care is managed
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.
|
|---|---|---|
|
Family Conflict Scale
|
25.4 score on a scale
Standard Deviation 4.1
|
24.4 score on a scale
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: 12-weekAdolescents 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.
Outcome measures
| Measure |
Experimental Group
n=21 Participants
Subjects will wear their personal pump (if appropriate), use a study insulin pen (if appropriate), a study CGM and study activity tracker (i.e. Fitbit). Participants will receive a weekly CloudConnect Report based on analysis of the weekly data gathered for each participant. The report will be sent via email once a week to both the subject and their parent(s). Subjects and parents will have weekly contact with the study team. Subjects will complete questionnaires at the beginning and end of the study. These questionnaires will ask subjects about:
* the communication within the family about the information shared in this report
* how subjects feel when blood sugar is high or low
* who takes responsibility of how diabetes care is managed
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.
|
Control Group
n=22 Participants
Subjects will wear their personal pump (if appropriate), use a study insulin pen (if appropriate), a study CGM and study activity tracker (i.e. Fitbit). Participants will not receive a CloudConnect Report. Subjects and parents will have weekly contact with the study team. Subjects will complete questionnaires at the beginning and end of the study. These questionnaires will ask subjects about:
* the communication within the family about the information shared in this report
* how subjects feel when blood sugar is high or low
* who takes responsibility of how diabetes care is managed
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.
|
|---|---|---|
|
Division of Diabetes Responsibilities Score
|
21.3 Score
Standard Deviation 3.1
|
23.1 Score
Standard Deviation 4.5
|
SECONDARY outcome
Timeframe: 12-weekScores 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.
Outcome measures
| Measure |
Experimental Group
n=21 Participants
Subjects will wear their personal pump (if appropriate), use a study insulin pen (if appropriate), a study CGM and study activity tracker (i.e. Fitbit). Participants will receive a weekly CloudConnect Report based on analysis of the weekly data gathered for each participant. The report will be sent via email once a week to both the subject and their parent(s). Subjects and parents will have weekly contact with the study team. Subjects will complete questionnaires at the beginning and end of the study. These questionnaires will ask subjects about:
* the communication within the family about the information shared in this report
* how subjects feel when blood sugar is high or low
* who takes responsibility of how diabetes care is managed
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.
|
Control Group
n=22 Participants
Subjects will wear their personal pump (if appropriate), use a study insulin pen (if appropriate), a study CGM and study activity tracker (i.e. Fitbit). Participants will not receive a CloudConnect Report. Subjects and parents will have weekly contact with the study team. Subjects will complete questionnaires at the beginning and end of the study. These questionnaires will ask subjects about:
* the communication within the family about the information shared in this report
* how subjects feel when blood sugar is high or low
* who takes responsibility of how diabetes care is managed
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.
|
|---|---|---|
|
Child Self Management Score
|
4 Score on a scale
Interval 3.0 to 9.5
|
4 Score on a scale
Interval 2.0 to 6.0
|
SECONDARY outcome
Timeframe: 12-weekAdolescent 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.
Outcome measures
| Measure |
Experimental Group
n=21 Participants
Subjects will wear their personal pump (if appropriate), use a study insulin pen (if appropriate), a study CGM and study activity tracker (i.e. Fitbit). Participants will receive a weekly CloudConnect Report based on analysis of the weekly data gathered for each participant. The report will be sent via email once a week to both the subject and their parent(s). Subjects and parents will have weekly contact with the study team. Subjects will complete questionnaires at the beginning and end of the study. These questionnaires will ask subjects about:
* the communication within the family about the information shared in this report
* how subjects feel when blood sugar is high or low
* who takes responsibility of how diabetes care is managed
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.
|
Control Group
n=22 Participants
Subjects will wear their personal pump (if appropriate), use a study insulin pen (if appropriate), a study CGM and study activity tracker (i.e. Fitbit). Participants will not receive a CloudConnect Report. Subjects and parents will have weekly contact with the study team. Subjects will complete questionnaires at the beginning and end of the study. These questionnaires will ask subjects about:
* the communication within the family about the information shared in this report
* how subjects feel when blood sugar is high or low
* who takes responsibility of how diabetes care is managed
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.
|
|---|---|---|
|
My-Q
|
93.5 Score on a scale
Standard Deviation 11.9
|
95.8 Score on a scale
Standard Deviation 10.7
|
SECONDARY outcome
Timeframe: 12-weekPopulation: Reduced numbers reflect missing data from individual participants.
Adolescent response to the question: "During the past week, did you talk with your parents about your diabetes management?"
Outcome measures
| Measure |
Experimental Group
n=20 Participants
Subjects will wear their personal pump (if appropriate), use a study insulin pen (if appropriate), a study CGM and study activity tracker (i.e. Fitbit). Participants will receive a weekly CloudConnect Report based on analysis of the weekly data gathered for each participant. The report will be sent via email once a week to both the subject and their parent(s). Subjects and parents will have weekly contact with the study team. Subjects will complete questionnaires at the beginning and end of the study. These questionnaires will ask subjects about:
* the communication within the family about the information shared in this report
* how subjects feel when blood sugar is high or low
* who takes responsibility of how diabetes care is managed
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.
|
Control Group
n=21 Participants
Subjects will wear their personal pump (if appropriate), use a study insulin pen (if appropriate), a study CGM and study activity tracker (i.e. Fitbit). Participants will not receive a CloudConnect Report. Subjects and parents will have weekly contact with the study team. Subjects will complete questionnaires at the beginning and end of the study. These questionnaires will ask subjects about:
* the communication within the family about the information shared in this report
* how subjects feel when blood sugar is high or low
* who takes responsibility of how diabetes care is managed
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.
|
|---|---|---|
|
Weekly Diabetes Communication
|
88 Percent of weeks with positive response
Standard Deviation 32
|
89 Percent of weeks with positive response
Standard Deviation 31
|
SECONDARY outcome
Timeframe: 12-weekPopulation: Reduced numbers reflect missing data from individual participants.
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.
Outcome measures
| Measure |
Experimental Group
n=20 Participants
Subjects will wear their personal pump (if appropriate), use a study insulin pen (if appropriate), a study CGM and study activity tracker (i.e. Fitbit). Participants will receive a weekly CloudConnect Report based on analysis of the weekly data gathered for each participant. The report will be sent via email once a week to both the subject and their parent(s). Subjects and parents will have weekly contact with the study team. Subjects will complete questionnaires at the beginning and end of the study. These questionnaires will ask subjects about:
* the communication within the family about the information shared in this report
* how subjects feel when blood sugar is high or low
* who takes responsibility of how diabetes care is managed
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.
|
Control Group
n=21 Participants
Subjects will wear their personal pump (if appropriate), use a study insulin pen (if appropriate), a study CGM and study activity tracker (i.e. Fitbit). Participants will not receive a CloudConnect Report. Subjects and parents will have weekly contact with the study team. Subjects will complete questionnaires at the beginning and end of the study. These questionnaires will ask subjects about:
* the communication within the family about the information shared in this report
* how subjects feel when blood sugar is high or low
* who takes responsibility of how diabetes care is managed
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.
|
|---|---|---|
|
Tone of Response
|
3.58 Score
Standard Deviation 0.90
|
3.84 Score
Standard Deviation 0.87
|
SECONDARY outcome
Timeframe: 12-weekPopulation: Reduced numbers reflect missing data from individual participants.
Adolescent responding to the question, "During the past week, did you change your insulin parameters?"
Outcome measures
| Measure |
Experimental Group
n=20 Participants
Subjects will wear their personal pump (if appropriate), use a study insulin pen (if appropriate), a study CGM and study activity tracker (i.e. Fitbit). Participants will receive a weekly CloudConnect Report based on analysis of the weekly data gathered for each participant. The report will be sent via email once a week to both the subject and their parent(s). Subjects and parents will have weekly contact with the study team. Subjects will complete questionnaires at the beginning and end of the study. These questionnaires will ask subjects about:
* the communication within the family about the information shared in this report
* how subjects feel when blood sugar is high or low
* who takes responsibility of how diabetes care is managed
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.
|
Control Group
n=21 Participants
Subjects will wear their personal pump (if appropriate), use a study insulin pen (if appropriate), a study CGM and study activity tracker (i.e. Fitbit). Participants will not receive a CloudConnect Report. Subjects and parents will have weekly contact with the study team. Subjects will complete questionnaires at the beginning and end of the study. These questionnaires will ask subjects about:
* the communication within the family about the information shared in this report
* how subjects feel when blood sugar is high or low
* who takes responsibility of how diabetes care is managed
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.
|
|---|---|---|
|
Change of Insulin Parameters
|
0.36 Percent of weeks with positive response
Standard Deviation 0.48
|
0.12 Percent of weeks with positive response
Standard Deviation 0.33
|
Adverse Events
Experimental Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control Group
Serious events: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Experimental Group
n=21 participants at risk
Subjects will wear their personal pump (if appropriate), use a study insulin pen (if appropriate), a study CGM and study activity tracker (i.e. Fitbit). Participants will receive a weekly CloudConnect Report based on analysis of the weekly data gathered for each participant. The report will be sent via email once a week to both the subject and their parent(s). Subjects and parents will have weekly contact with the study team. Subjects will complete questionnaires at the beginning and end of the study. These questionnaires will ask subjects about:
* the communication within the family about the information shared in this report
* how subjects feel when blood sugar is high or low
* who takes responsibility of how diabetes care is managed
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.
|
Control Group
n=22 participants at risk
Subjects will wear their personal pump (if appropriate), use a study insulin pen (if appropriate), a study CGM and study activity tracker (i.e. Fitbit). Participants will not receive a CloudConnect Report. Subjects and parents will have weekly contact with the study team. Subjects will complete questionnaires at the beginning and end of the study. These questionnaires will ask subjects about:
* the communication within the family about the information shared in this report
* how subjects feel when blood sugar is high or low
* who takes responsibility of how diabetes care is managed
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.
|
|---|---|---|
|
Nervous system disorders
hypoglycemic seizure
|
0.00%
0/21 • 12-weeks
|
4.5%
1/22 • Number of events 1 • 12-weeks
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place