App-Based Certified Diabetes Education Therapy (AB-CDE)

Inclusion criteria

• Diagnosis of type 1 diabetes mellitus for at least 1 year.
• Age 18 years and older.
• Able to read, write and understand spoken English
• HbA1c or GMI 7.5- 11.5% at screening. GMI (%) = 3.31 + 0.02392 × \[mean glucose in mg/dL\] based on prior 30 days of CGM data with at least 70% time CGM active\[6\]
• Use of multiple daily insulin injections (MDI) for at least 30 days at the time of screening visit.
• Willing to use the approved study insulin and devices while on study - Humalog and Basaglar Tempo pens, Dexcom G6 CGM, study iPhone, Apple watch
• Willingness and ability to independently follow all study procedures, including attending all clinic and DSMES and behavioral health visits.
• Total daily insulin requirements of less than 200 units

Exclusion criteria

• Female of childbearing potential who is pregnant or intending to become pregnant or breast-feeding or is not using adequate contraceptive methods. Acceptable contraception includes birth control pill / patch / vaginal ring, Depo-Provera, Norplant, an IUD, the double barrier method (the woman uses a diaphragm and spermicide, and the man uses a condom), or abstinence.
• History of stroke, heart failure, myocardial infarction, angina pectoris, or coronary arterial bypass graft or angioplasty.
• Renal insufficiency (GFR \< 60 ml/min, using either MDRD\*\
• or CKD-EPI# equation as reported by the laboratory).
• Liver failure, cirrhosis, or any other liver disease that compromises liver function as determined by the investigator.
• History of severe hypoglycemia during the 3 months prior to screening or hypoglycemia unawareness as judged by the investigator. Participants will complete a hypoglycemia awareness questionnaire. Participants will be excluded for four or more R responses.
• History of diabetes ketoacidosis during the 3 months prior to screening, as diagnosed on hospital admission or as judged by the investigator.
• History of psychiatric admission during the 6 months prior to screening.
• Adrenal insufficiency.
• Any active infection.
• Known or suspected abuse of alcohol, narcotics, or illicit drugs.
• Uncontrolled seizure disorder.
• Active foot ulceration.
• Severe peripheral arterial disease characterized by ischemic rest pain or severe claudication.
• Major surgical operation within 30 days prior to screening.
• Use of an investigational drug within 30 days prior to screening.
• Chronic usage of any immunosuppressive medication (such as cyclosporine, azathioprine, sirolimus, or tacrolimus).
• Bleeding disorder, treatment with warfarin, or platelet count below 50,000.
• Allergy to Humalog or Basaglar insulin.
• Current chronic administration of oral or parenteral corticosteroids.
• Any life-threatening disease, including malignant neoplasms and medical history of malignant neoplasms within the 5 years prior to screening (except basal and squamous cell skin cancer).
• Initiation or titration of any medication used to lower glucose other than insulin in the 6 weeks prior to screening (e.g. metformin or semaglutide). Participants will not be excluded if they are non-insulin glucose lowering medication at a stable dose with no plans for discontinuation or dose modification during the course of the study). A positive response to any of the questions from the Physical Activity Readiness Questionnaire (see Appendix A) with one exception: participant will not be excluded if taking a single blood pressure medication and blood pressure is controlled on the medication (blood pressure is less than 140/90 mmHg).
• Any chest discomfort with physical activity, including pain or pressure, or other types of discomfort.
• Gastroparesis.
• On a very low carbohydrate diet (less than 50g per day)
• Taking part in another diabetes or obesity-related treatment study.
• Any clinically significant disease or disorder which, in the opinion of the Investigator, may jeopardize the participant's safety or compliance with the protocol.