PACTAID App in Adults With Type 1 Diabetes to Help Manage Exercise

Inclusion Criteria:

• Male or Female between age of 18-65 yrs.

• T1D diagnosis will be confirmed by C- Peptide (≤0.6 ng/ml) with a simultaneousfasting glucose concentration 80-225 mg/dL.

• T1D using AID either tandem Control IQ, Medtronic 780G, Omnipod 5 or Ilet bionicpancreas for diabetes management at the time of screening for at least 3-monthduration.

• CGM and insulin pump data available for > 70% for last 2 weeks.

• T1D without atherosclerotic cardiovascular disease

• HbA1c ≤10 %

• Able to understand English language.

• Currently using an insulin-to-carbohydrate ratio to calculate meal bolus sizes.

• Willing to complete study procedures.

• Willing to wear study devices.

• An understanding of and willingness to follow the protocol, perform all 3 types ofexercises as per protocol, and sign the informed consent.

• Non-smoker

• Satisfactory EKG in last one year or if not available, satisfactory baseline EKG atscreening

Exclusion Criteria:

• Anti-hyperglycemic drugs other than insulin including metformin.

• Pregnancy or contemplating pregnancy in study

• Untreated hyperthyroidism or hypothyroidism, abnormal (out of Reference range) TSHat the time of screening

• Severe hypoglycemia or DKA in last 3 months.

• Baseline exercise status-those already doing vigorous exercise such as 1 hour perday will be excluded.

• BMI ≥35 kg/m2

• Obstructive sleep apnea not controlled on CPAP.

• Chronic obstructive pulmonary disease

• Asthma limiting exercise.

• Uncontrolled hypertension, Blood pressure ≥ 140/90 mmHg with ≥ 2 antihypertensivemedications

• Clinically diagnosed obstructive coronary artery disease or any other significantcardiac condition or heart failure

• Uncontrolled or recurrent ventricular tachycardia

• Any medication affecting heart rate.

• Clinical diagnosis of unstable proliferative diabetic retinopathy

• Previous Organ Transplant with or without current graft function

• Currently receiving chemotherapy or long-term immunosuppressant (glucocorticoidsetc.) therapy

• COVID positive at the time of screening

• Clinically diagnosed autonomic neuropathy

• Abnormal liver function test results (Transaminase >3 times the upper limit ofnormal); testing required for subjects taking medications known to affect liverfunction or with diseases known to affect liver function.

• Abnormal renal function test results (calculated GFR <60 mL/min/1.73m2)

• Active gastroparesis

• Abuse of alcohol or recreational drugs

• Infectious process not anticipated to resolve prior to study procedures (e.g.,meningitis, pneumonia, osteomyelitis).

• If on anti-depressant, lack of stability on the medication for the past 2 monthsprior to enrollment in the study

• Any known medical condition that in the judgment of the investigator might interferewith the completion of the protocol such as the following examples:

1. Inpatient psychiatric treatment in the past 6 months

2. Presence of a known adrenal disorder

3. A recent injury to body or limb, muscular disorder, use of any medication, anycarcinogenic disease, or other significant medical disorder if that injury,medication, or disease in the judgment of the investigator will affect thecompletion of the protocol

4. Participating in any other treatment study

Note: Other protocol defined Inclusion/Exclusion Criteria may apply.

Eligibility last updated 08/15/2024. Questions regarding updates should be directed to the study team contact.