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

Prior treatment

• Anti-hyperglycemic drugs other than insulin including metformin.
• Previous Organ Transplant with or without current graft function
• Currently receiving chemotherapy or long-term immunosuppressant (glucocorticoids etc.) therapy
• 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 months prior to enrollment in the study

Other illness

• Chronic obstructive pulmonary disease
• Uncontrolled hypertension, Blood pressure ≥ 140/90 mmHg with ≥ 2 antihypertensive medications
• Clinically diagnosed obstructive coronary artery disease or any other significant cardiac condition or heart failure
• Any medication affecting heart rate.
• COVID positive at the time of screening
• Any known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:
  • Inpatient psychiatric treatment in the past 6 months
  • Presence of a known adrenal disorder
  • A recent injury to body or limb, muscular disorder, use of any medication, any carcinogenic disease, or other significant medical disorder if that injury, medication, or disease in the judgment of the investigator will affect the completion of the protocol
  • 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.

Lab values

• Abnormal liver function test results (Transaminase \>3 times the upper limit of normal); testing required for subjects taking medications known to affect liver function or with diseases known to affect liver function.
• Abnormal renal function test results (calculated GFR \<60 mL/min/1.73m2)

Other

• Pregnancy or contemplating pregnancy in study
• Untreated hyperthyroidism or hypothyroidism, abnormal (out of Reference range) TSH at the time of screening
• Severe hypoglycemia or DKA in last 3 months.
• Baseline exercise status-those already doing vigorous exercise such as 1 hour per day will be excluded.
• BMI ≥35 kg/m2
• Obstructive sleep apnea not controlled on CPAP.
• Asthma limiting exercise.
• Uncontrolled or recurrent ventricular tachycardia
• Clinical diagnosis of unstable proliferative diabetic retinopathy
• Clinically diagnosed autonomic neuropathy
• Active gastroparesis

• Male or Female between age of 18-65 yrs.
• T1D diagnosis will be confirmed by C- Peptide (≤0.6 ng/ml) with a simultaneous fasting glucose concentration 80-225 mg/dL.
• T1D using AID either tandem Control IQ, Medtronic 780G, Omnipod 5 or Ilet bionic pancreas for diabetes management at the time of screening for at least 3-month duration.
• 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 of exercises as per protocol, and sign the informed consent.
• Non-smoker
• Satisfactory EKG in last one year or if not available, satisfactory baseline EKG at screening