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

Type 1 Diabetes Mellitus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03676465
• Other study ID #: 20958
• Secondary ID: 5R01LM012090
• Status: Completed
• Phase: N/A
• Start date: January 18, 2019
• Est. completion date: February 2, 2021

Study information

• Verified date: November 2023
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: February 2, 2021
• Est. primary completion date: February 2, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years to 17 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Virginia Center for Diabetes Technology	Charlottesville	Virginia

Sponsors (2)

Lead Sponsor	Collaborator
University of Virginia	National Library of Medicine (NLM)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Overall (12 weeks)
Secondary	HbA1c, Final	Final HbA1c measure	12-week
Secondary	Mean Glucose by CGM	Average glucose level measured by CGM	12-week
Secondary	Percent Time <70 mg/dL	Percentage of time participant spent with blood glucose below 70 mg/dL	12-week
Secondary	Percent Time >180 mg/dL	Percentage of time participant spent with blood glucose greater than 180 mg/dL	12-week
Secondary	Low Blood Glucose Episodes Per Week	The number of episodes of hypoglycemia experienced each week	12-week
Secondary	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.	12-week
Secondary	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.	12-week
Secondary	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.	12-week
Secondary	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.	12-week
Secondary	Weekly Diabetes Communication	Adolescent response to the question: "During the past week, did you talk with your parents about your diabetes management?"	12-week
Secondary	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.	12-week
Secondary	Change of Insulin Parameters	Adolescent responding to the question, "During the past week, did you change your insulin parameters?"	12-week