Clinical trial NCT03676465: CloudConnect: Predictive And Retrospective Clinical Decision Support For Chronic Disease Management
Official title: CloudConnect: Predictive And Retrospective Clinical Decision Support For Chronic Disease Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
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)
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: National Library of Medicine (NLM)
First posted: 2018-09-18
Enrollment: 132
Sex: ALL
Minimum age (years): 12
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: OTHER

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.

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

Primary outcomes:
measure: Family Communication Inventory Questionnaire
timeFrame: 12-weeks
Secondary outcomes:
measure: Glucose Time in Range 70-180 mg/dL, Overall
timeFrame: Overall (12 weeks)
measure: HbA1c, Final
timeFrame: 12-week
measure: Mean Glucose by CGM
timeFrame: 12-week
measure: Percent Time <70 mg/dL
timeFrame: 12-week
measure: Percent Time >180 mg/dL
timeFrame: 12-week
measure: Low Blood Glucose Episodes Per Week
timeFrame: 12-week
measure: Family Conflict Scale
timeFrame: 12-week
measure: Division of Diabetes Responsibilities Score
timeFrame: 12-week
measure: Child Self Management Score
timeFrame: 12-week
measure: My-Q
timeFrame: 12-week
measure: Weekly Diabetes Communication
timeFrame: 12-week
measure: Tone of Response
timeFrame: 12-week
measure: Change of Insulin Parameters
timeFrame: 12-week
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Center for Diabetes Technology
state: Virginia
Study officials:
affiliation: University of Virginia
name: Mark D DeBoer, MD
role: PRINCIPAL_INVESTIGATOR
References: