NCT03676465

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

Completed NA Results posted Last updated 19 December 2023

What this trial tests

NA trial testing CloudConnect Report in Type 1 Diabetes Mellitus in 132 participants. Completed in 2 February 2021.

Timeline

18 January 2019

Primary endpoint
2 February 2021

2 February 2021

Quick facts

Lead sponsor	University of Virginia
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	132
Start date	18 January 2019
Primary completion	2 February 2021
Estimated completion	2 February 2021
Sites	1 location across United States

Drugs / interventions tested

• CloudConnect Report
• Will not receive a CloudConnect Report

Conditions studied

• Type 1 Diabetes Mellitus — all drugs for Type 1 Diabetes Mellitus →

Sponsor

University of Virginia

Who can join

Adults 12 to 17, any sex, with Type 1 Diabetes Mellitus. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Family Communication Inventory Questionnaire Primary · 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 commun

Group	Value	95% CI
Experimental Group	12.3	± 3.8
Control Group	11.5	± 6.7

Glucose Time in Range 70-180 mg/dL, Overall Secondary · Overall (12 weeks)

Percentage of time during the study with glucose value between 70-180 mg/dL as measured by continuous glucose monitor, CGM

Group	Value	95% CI
Experimental Group	47.6	± 12.7
Control Group	40.4	± 7.5

HbA1c, Final Secondary · 12-week

Final HbA1c measure

Group	Value	95% CI
Experimental Group	7.58	± 0.94
Control Group	7.71	± 1.11

Mean Glucose by CGM Secondary · 12-week

Average glucose level measured by CGM

Group	Value	95% CI
Experimental Group	198.2	± 28.2
Control Group	201.0	± 27.6

Percent Time <70 mg/dL Secondary · 12-week

Percentage of time participant spent with blood glucose below 70 mg/dL

Group	Value	95% CI
Experimental Group	1.1	0.6 – 2.9
Control Group	1.2	0.7 – 2.5

Percent Time >180 mg/dL Secondary · 12-week

Percentage of time participant spent with blood glucose greater than 180 mg/dL

Group	Value	95% CI
Experimental Group	53.6	± 12.8
Control Group	54.0	± 12.8

Low Blood Glucose Episodes Per Week Secondary · 12-week

The number of episodes of hypoglycemia experienced each week

Group	Value	95% CI
Experimental Group	2.75	1.8 – 6.35
Control Group	3.3	1.2 – 5.3

Family Conflict Scale Secondary · 12-week

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.

Group	Value	95% CI
Experimental Group	25.4	± 4.1
Control Group	24.4	± 5.1

Division of Diabetes Responsibilities Score Secondary · 12-week

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.

Group	Value	95% CI
Experimental Group	21.3	± 3.1
Control Group	23.1	± 4.5

Child Self Management Score Secondary · 12-week

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.

Group	Value	95% CI
Experimental Group	4	3 – 9.5
Control Group	4	2 – 6

My-Q Secondary · 12-week

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.

Group	Value	95% CI
Experimental Group	93.5	± 11.9
Control Group	95.8	± 10.7

Weekly Diabetes Communication Secondary · 12-week

Adolescent response to the question: "During the past week, did you talk with your parents about your diabetes management?"

Group	Value	95% CI
Experimental Group	88	± 32
Control Group	89	± 31

Adverse events — posted to ClinicalTrials.gov

Time frame: 12-weeks. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Experimental Group

Serious: 0/21 (0%)

Deaths: 0/21

Control Group

Serious: 1/22 (5%)

Deaths: 0/22

Serious adverse events (1 terms)

Reaction	System	Experimental Group	Control Group
hypoglycemic seizure	Nervous system disorders	—	—

Most-reported serious reactions: hypoglycemic seizure.

Data from ClinicalTrials.gov NCT03676465 adverse events section.

Sponsor's own description

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).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. Effect of an Automated Advice Algorithm (CloudConnect) on Adolescent-Parent Diabetes-Specific Communication and Glycemic Management: A Randomized Trial.
   DeBoer MD, Valdez R, Corbett JP, Krauthause K, et al · · 2023 · cited 4× · PMID 37027118 · DOI 10.1007/s13300-023-01401-9