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

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.