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

NCT ID: NCT03676465

Last Updated: 2023-12-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 132 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-01-18
• Study Completion Date: 2021-02-02

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).

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

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 Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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

Group Type: EXPERIMENTAL

CloudConnect Report

Intervention Type: 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.

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

Group Type: ACTIVE_COMPARATOR

Will not receive a CloudConnect Report

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 17 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Library of Medicine (NLM)

NIH

Sponsor Role: collaborator

University of Virginia

OTHER

Sponsor Role: lead

Responsible Party

Mark D. DeBoer, MD, MSc., MCR

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mark D DeBoer, MD

Role: PRINCIPAL_INVESTIGATOR

University of Virginia

Locations

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 37027118 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

5R01LM012090

Identifier Type: NIH

Identifier Source: secondary_id

View Link

20958

Identifier Type: -

Identifier Source: org_study_id