Type 1 Diabetes MellitusNCT03676465
CloudConnect: Predictive And Retrospective Clinical Decision Support For Chronic Disease Management
A study testing CloudConnect Report and Will not receive a CloudConnect Report in people with Type 1 Diabetes Mellitus, run by University of Virginia at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 12 to 17 years
- Conditions the study is for
- Type 1 Diabetes Mellitus
- What is being tested?
- CloudConnect Report and Will not receive a CloudConnect Report
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2019to 2 Feb 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Willingness to provide informed consent
- Adolescents ages ≥12 and ≤ 17 years old with a parent/guardian (18+ yo) who is willing to participate with the child
- HbA1c ≥7 and ≤ 11 % (point-of-care machine or local laboratory [i.e. LabCorp]) (*This criteria only applies to the Main Study, it does not apply to the Pilot Study*)
- Willingness and ability to comply with scheduled visits and study procedures
- Willingness to comply with all the study devices during the entire trial (i.e. commercially-available CGM, Fitbit, Companion Medical inPen)
- One month stability on insulin parameters prior to enrollment
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- MDI users should use Humalog® and Novolog® insulin to use in study insulin pen
- Type 1 diabetes mellitus diagnosed at least one year prior to enrollment in the study as noted by the following:
- Criteria for documented hyperglycemia (at least 1 criterion must be met):
- Fasting glucose ≥ 126mg/dL-confirmed
- Two-hour Oral Glucose Tolerance Test (OGTT) ≥200mg/dL-confirmed hemoglobin A1c (HbA1c) ≥6.5% and documented by history - confirmed Random glucose ≥200 mg/dL with symptoms
- No data at diagnosis is available but the participant has a convincing history of hyperglycemia consistent with diabetes
- 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.
- Not currently known to be pregnant, breast feeding, or intending to become pregnant (females). A negative urine pregnancy test will be required for adolescent girls who are able to become pregnant. Participants who become pregnant will be discontinued from the study.
- Ability to access the Internet to provide data to the clinical team or to travel to the research center so that the study equipment can be downloaded.
- Medication stability in the preceding two months if taking antihypertensive, thyroid, anti-depressant or lipid lowering medication.
Who cannot join
- Children outside the ages of 12-17 y.o. or those who do not have a parent/guardian willing to participate
- Diabetic ketoacidosis in the past 6 months
- Pregnancy, breast-feeding, or intention of becoming pregnant
- Current or recent alcohol or drug abuse by patient history
- Mental incapacity, unwillingness or language barriers precluding adequate understanding, cooperation, or ability to fill out questionnaires.
- Any skin condition that prevents sensor placement (e.g., bad sunburn, pre-existing dermatitis, intertrigo, psoriasis, extensive scarring, cellulitis)
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- Psychiatric disorders that would interfere with study tasks (e.g. cognitive disability, psychiatric hospitalization within 12 months)
- Use of acetaminophen (*this criteria only applies when the CGM version being used is older than the G6*)
- Use of long-acting insulin that is not Lantus or Tresiba
- For subjects who currently use a close-loop insulin pump and CGM: not being willing to turn off the closed-loop function
- Conditions that would make use of a CGM difficult (e.g., blindness, severe arthritis, immobility)
- Cystic fibrosis
- Current use of oral/inhaled glucocorticoids or other medications, which in the judgment of the investigator would be a contraindication to participation in the study
- Any other comorbidity that at the judgment of the investigator may interfere with the participation on the study (i.e. uncontrolled high blood pressure or thyroid disease, current diabetic microvascular complications, current diagnose of gastroparesis)
- Severe hypoglycemia resulting in seizure or loss of consciousness in the 6 months prior to enrollment
- Use of a device that may pose electromagnetic compatibility issues and/or radiofrequency interference with the Dexcom CGM (implantable cardioverter-defibrillator, electronic pacemaker, neurostimulator, intrathecal pump, and cochlear implants)
- Active enrollment in another clinical trial
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Virginia Center for Diabetes Technology
Charlottesville, Virginia, 22904
About this study
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).
Read the 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
- Being tested
- CloudConnect Report, Will not receive a CloudConnect Report
- Keywords
- Type 1 Diabetes Mellitus (T1D), Continuous Glucose Monitor (CGM), Activity Monitor (i.e. Fitbit), Hemoglobin A1c (HbA1c), Companion Medical inPen, Insulin Pump, Multiple Daily Injections (MDI)
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CloudConnect ReportOther
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.
Will not receive a CloudConnect ReportOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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:
* 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 Receives: Other: CloudConnect Report |
| 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:
* 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 Receives: Other: Will not receive a CloudConnect Report |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12-weeks
Secondary outcomes (13)
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
Measured: Overall (12 weeks)
HbA1c, Final
Final HbA1c measure
Measured: 12-week
Mean Glucose by CGM
Average glucose level measured by CGM
Measured: 12-week
Percent Time <70 mg/dL
Percentage of time participant spent with blood glucose below 70 mg/dL
Measured: 12-week
Percent Time >180 mg/dL
Percentage of time participant spent with blood glucose greater than 180 mg/dL
Measured: 12-week
Low Blood Glucose Episodes Per Week
The number of episodes of hypoglycemia experienced each week
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12-week
Weekly Diabetes Communication
Adolescent response to the question: "During the past week, did you talk with your parents about your diabetes management?"
Measured: 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.
Measured: 12-week
Change of Insulin Parameters
Adolescent responding to the question, "During the past week, did you change your insulin parameters?"
Measured: 12-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2018
- Study start18 Jan 2019
- Primary completion2 Feb 2021
- Study completion2 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 Diabetes MellitusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Collaborators
- National Library of Medicine (NLM)
- Responsible party
- Principal investigator, Mark D. DeBoer, MD, MSc., MCR, University of Virginia
- Investigators
- Mark D DeBoer, MD, Principal investigator, University of Virginia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03676465
- Sponsor's protocol ID
- 20958
- Other IDs
- 5R01LM012090
- Status last verified
- Nov 2023
- First submitted
- 17 Sep 2018
- Last updated
- 19 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37027118
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CloudConnect: Predictive And Retrospective Clinical Decision Support For Chronic Disease Management
- ClinicalTrials.gov ID
- NCT03676465
- Acronym / sponsor ID
- 20958
- Conditions
- Type 1 Diabetes Mellitus
- Keywords
- Type 1 Diabetes Mellitus (T1D), Continuous Glucose Monitor (CGM), Activity Monitor (i.e. Fitbit), Hemoglobin A1c (HbA1c), Companion Medical inPen, Insulin Pump, Multiple Daily Injections (MDI)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Collaborators
- National Library of Medicine (NLM)
- Study start
- 18 Jan 2019 (actual)
- Primary completion
- 2 Feb 2021 (actual)
- Study completion
- 2 Feb 2021 (actual)
- First posted
- 18 Sep 2018 (actual)
- Results
- Posted 19 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Other: CloudConnect ReportSubjects 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 |
| Control Group | Active comparator | Other: Will not receive a CloudConnect ReportSubjects 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 |
Who may qualify
- Ages
- 12 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (22 listed)
- Willingness to provide informed consent
- Adolescents ages ≥12 and ≤ 17 years old with a parent/guardian (18+ yo) who is willing to participate with the child
- HbA1c ≥7 and ≤ 11 % (point-of-care machine or local laboratory [i.e. LabCorp]) (*This criteria only applies to the Main Study, it does not apply to the Pilot Study*)
- Willingness and ability to comply with scheduled visits and study procedures
- Willingness to comply with all the study devices during the entire trial (i.e. commercially-available CGM, Fitbit, Companion Medical inPen)
Key exclusion criteria (20 listed)
- Children outside the ages of 12-17 y.o. or those who do not have a parent/guardian willing to participate
- Diabetic ketoacidosis in the past 6 months
- Pregnancy, breast-feeding, or intention of becoming pregnant
- Current or recent alcohol or drug abuse by patient history
- Mental incapacity, unwillingness or language barriers precluding adequate understanding, cooperation, or ability to fill out questionnaires.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CloudConnect ReportSubjects 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 | Experimental Group |
| Will not receive a CloudConnect ReportSubjects 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. | Other | Control Group |
Primary outcome
Family Communication Inventory Questionnaire
Time frame: 12-weeks
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.
13 secondary outcomes
Glucose Time in Range 70-180 mg/dL, Overall
Time frame: Overall (12 weeks)
HbA1c, Final
Time frame: 12-week
Mean Glucose by CGM
Time frame: 12-week
Percent Time <70 mg/dL
Time frame: 12-week
Percent Time >180 mg/dL
Time frame: 12-week
Low Blood Glucose Episodes Per Week
Time frame: 12-week
Family Conflict Scale
Time frame: 12-week
Division of Diabetes Responsibilities Score
Time frame: 12-week
Child Self Management Score
Time frame: 12-week
My-Q
Time frame: 12-week
Weekly Diabetes Communication
Time frame: 12-week
Tone of Response
Time frame: 12-week
Change of Insulin Parameters
Time frame: 12-week
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37027118DeBoer 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mark D DeBoer, MD principal investigator
University of Virginia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CloudConnect Report and Will not receive a CloudConnect Report in people with Type 1 Diabetes Mellitus, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Family Communication Inventory Questionnaire (time frame: 12-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03676465, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.