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

• ClinicalTrials.gov Identifier: NCT03676465
• Recruitment Status: Completed
• First Posted: September 18, 2018
• Last Update Posted: December 6, 2021
• Sponsor: University of Virginia
• Collaborator: National Library of Medicine (NLM)
• Information provided by (Responsible Party): Mark D. DeBoer, MD, MSc., MCR, University of Virginia

Study Description

Brief 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).

Condition or disease	Intervention/treatment	Phase
Type 1 Diabetes Mellitus	Other: CloudConnect Report; Other: Will not receive a CloudConnect Report	Not Applicable

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

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 66 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Subjects 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)
• Primary Purpose: Other
• Official Title: CloudConnect: Predictive And Retrospective Clinical Decision Support For Chronic Disease Management
• Actual Study Start Date: September 11, 2018
• Actual Primary Completion Date: February 2, 2021
• Actual Study Completion Date: February 2, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Family Communication Inventory Questionnaire [ Time Frame: 3 months ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 17 Years (Child)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

Inclusion Criteria:

• 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
• 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.

Exclusion Criteria:

• 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)
• 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

Contacts and Locations

Locations

United States, Virginia

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, United States, 22904

Sponsors and Collaborators

University of Virginia

National Library of Medicine (NLM)

Investigators

• Principal Investigator: Mark D DeBoer, MD; University of Virginia

More Information

• Responsible Party: Mark D. DeBoer, MD, MSc., MCR, Principal Investigator, University of Virginia
• ClinicalTrials.gov Identifier: NCT03676465
• Other Study ID Numbers: 20958; 5R01LM012090 ( U.S. NIH Grant/Contract )
• First Posted: September 18, 2018
• Last Update Posted: December 6, 2021
• Last Verified: November 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Mark D. DeBoer, MD, MSc., MCR, University of Virginia:

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)

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 1; Chronic Disease; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Disease Attributes; Pathologic Processes