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| ID | Type | Description | Link |
|---|---|---|---|
| 5R01LM012090 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Library of Medicine (NLM) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Group | Experimental | 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:
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| Control Group | Active Comparator | 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:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CloudConnect Report | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Overall (12 weeks) |
| HbA1c, Final |
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Inclusion Criteria:
Criteria for documented hyperglycemia (at least 1 criterion must be met):
Criteria for requiring insulin at diagnosis (at least 1 criterion must be met):
Participant required insulin at diagnosis and continually thereafter
Participant did not start insulin at diagnosis but upon investigator review likely needed insulin (significant hyperglycemia that did not respond to oral agents) and did require insulin eventually and used continually)
The diagnosis of type 1 diabetes mellitus does not require documentation of C-peptide level or islet cell antibody positivity.
Commitment to maintaining uninterrupted availability via cell phone at all times
No diabetes complications
Participants must demonstrate English proficiency and proper mental status and cognition for completion of the study.
Exclusion Criteria:
No eligiblity criteria is required for parent(s)/guardian(s) other than the legal relationship and 18+ yo.
List any restrictions on use of other drugs or treatments.
o Use of anti-diabetic agents other than short-acting insulin for CSII subjects or long-acting insulin for MDI subjects, including: metformin, sulfonylureas, meglitinides, thiazolidinediones, dipeptidyl peptidase 4 (DPP-4) inhibitors, glucagon-like peptide 1 agonists and alpha-glucosidase inhibitors
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| Name | Affiliation | Role |
|---|---|---|
| Mark D DeBoer, MD | University of Virginia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Virginia Center for Diabetes Technology | Charlottesville | Virginia | 22904 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37027118 | Derived | DeBoer MD, Valdez R, Corbett JP, Krauthause K, Wakeman CA, Luke AS, Oliveri MC, Chernavvsky DR, Patek SD. Effect of an Automated Advice Algorithm (CloudConnect) on Adolescent-Parent Diabetes-Specific Communication and Glycemic Management: A Randomized Trial. Diabetes Ther. 2023 May;14(5):899-913. doi: 10.1007/s13300-023-01401-9. Epub 2023 Apr 7. |
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38 participants (19 adolescent+parent dyads) dropped out prior to randomization.
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.
| ID | Title | Description |
|---|---|---|
| FG000 | 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:
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. |
| FG001 | 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:
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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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These data represent the adolescent participants in the trial. Data were not collected regarding the parent who participated in survey questionnaires.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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:
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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | data refer to adolescent participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Mean | Standard Deviation | Score on a scale | 12-weeks |
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12-weeks
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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:
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. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hypoglycemic seizure | Nervous system disorders | Systematic Assessment | Participant received insulin for dinner but did not eat much. She then went to a store with her sister who reports that the CGM was alarming and participant said her glucose was in the 60s. While waiting to buy a drink, she collapsed with a seizure. |
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We did not recruit our target number of participants because of changes in diabetes management during the study, with an increase in use of closed-loop systems, which were an exclusion criterion.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Mark DeBoer | University of Virginia | (434) 924-5956 | deboer@virginia.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 12, 2020 | May 3, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | May 12, 2020 | May 3, 2023 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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Subjects (child/parent dyad, with child and parent counted as separate subjects randomized together) will be randomized to either a Control Group or an Experimental Group. Both groups will use a study CGM and activity tracker. MDI users will use an inPen to dispense their insulin treatment with their personal insulin. Subjects who use an insulin pump to care for their diabetes will use their personal pump and their personal insulin during the study. All subjects will be asked to download their equipment each week. The study team will communicate with both the subject and their parent(s) each week to discuss their diabetes management. Subjects will complete questionnaires at the beginning and end of the study.
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| Will not receive a CloudConnect Report | Other | 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. |
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Final HbA1c measure
| 12-week |
| Mean Glucose by CGM | Average glucose level measured by CGM | 12-week |
| Percent Time <70 mg/dL | Percentage of time participant spent with blood glucose below 70 mg/dL | 12-week |
| Percent Time >180 mg/dL | Percentage of time participant spent with blood glucose greater than 180 mg/dL | 12-week |
| Low Blood Glucose Episodes Per Week | The number of episodes of hypoglycemia experienced each week | 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. | 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. | 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. | 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. | 12-week |
| Weekly Diabetes Communication | Adolescent response to the question: "During the past week, did you talk with your parents about your diabetes management?" | 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. | 12-week |
| Change of Insulin Parameters | Adolescent responding to the question, "During the past week, did you change your insulin parameters?" | 12-week |
| BG001 | 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:
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. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
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| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | data refer to adolescent participants | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | data refer to adolescent participants | Count of Participants | Participants |
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| Race (NIH/OMB) | data refer to adolescent participants | Count of Participants | Participants |
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| Region of Enrollment | Number | adolescents |
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| Family Communication Inventory, Frequency scale | 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. | Mean | Standard Deviation | units on a scale: FCI, Frequency |
|
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:
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. |
| OG001 | 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:
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. |
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| Secondary | 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 | Posted | Mean | Standard Deviation | percentage of time in range 70-180 mg/dL | Overall (12 weeks) |
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| Secondary | HbA1c, Final | Final HbA1c measure | Posted | Mean | Standard Deviation | % of Hb | 12-week |
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| Secondary | Mean Glucose by CGM | Average glucose level measured by CGM | Posted | Mean | Standard Deviation | mg/dL | 12-week |
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| Secondary | Percent Time <70 mg/dL | Percentage of time participant spent with blood glucose below 70 mg/dL | Posted | Median | Inter-Quartile Range | % of time | 12-week |
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| Secondary | Percent Time >180 mg/dL | Percentage of time participant spent with blood glucose greater than 180 mg/dL | Posted | Mean | Standard Deviation | % of time | 12-week |
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| Secondary | Low Blood Glucose Episodes Per Week | The number of episodes of hypoglycemia experienced each week | Posted | Median | Inter-Quartile Range | episodes per week | 12-week |
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| Secondary | 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. | Posted | Mean | Standard Deviation | score on a scale | 12-week |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Score | 12-week |
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| Secondary | 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. | Posted | Median | Inter-Quartile Range | Score on a scale | 12-week |
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| Secondary | 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. | Posted | Mean | Standard Deviation | Score on a scale | 12-week |
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| Secondary | Weekly Diabetes Communication | Adolescent response to the question: "During the past week, did you talk with your parents about your diabetes management?" | Reduced numbers reflect missing data from individual participants. | Posted | Mean | Standard Deviation | Percent of weeks with positive response | 12-week |
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| Secondary | 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. | Reduced numbers reflect missing data from individual participants. | Posted | Mean | Standard Deviation | Score | 12-week |
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| Secondary | Change of Insulin Parameters | Adolescent responding to the question, "During the past week, did you change your insulin parameters?" | Reduced numbers reflect missing data from individual participants. | Posted | Mean | Standard Deviation | Percent of weeks with positive response | 12-week |
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| 0 |
| 21 |
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | 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:
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. | 0 | 22 | 1 | 22 | 0 | 22 |
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| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |