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

NCT03676465 | Completed Results

• 2 other identifiers: 209585R01LM012090
• Study Type: interventional
• Target: 132
• Locations: 1 country
• Sites: 1

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).

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)

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (13)

• Glucose Time in Range 70-180 mg/dL, Overall

  Overall (12 weeks)

• HbA1c, Final

  12-week

• Mean Glucose by CGM

  12-week

• Percent Time <70 mg/dL

  12-week

• Percent Time >180 mg/dL

  12-week

Study Arms (2)

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

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

Other: Will not receive a CloudConnect Report

Interventions

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.

Experimental Group

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.

Control Group

Eligibility Criteria

• Age: 12 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead
• National Library of Medicine (NLM): collaborator

Study Sites (1)

University of Virginia Center for Diabetes Technology

Charlottesville, Virginia, 22904, United States

Location

Related Publications (1)

• 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.

  PMID: 37027118 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

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.

Results Point of Contact

• Title: Dr. Mark DeBoer
• Organization: University of Virginia

deboer@virginia.edu

(434) 924-5956

Study Officials

• Mark D DeBoer, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: 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.

Study Record Dates

• First Submitted: September 17, 2018
• First Posted: September 18, 2018
• Study Start: January 18, 2019
• Primary Completion: February 2, 2021
• Study Completion: February 2, 2021
• Last Updated: December 19, 2023
• Results First Posted: December 19, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)