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

Enrolling by invitation · Not applicable

Conditions studied: Type 1 Diabetes Mellitus

In brief

The purpose of this trial is to test and refine the PACTAID smart phone application in adults with type 1 diabetes mellitus to help manage exercise while on automated insulin delivery systems with the goal of improving glycemic control during and after exercise as well as improving multiple other cardiovascular risk factors.

Key facts

Study ID

NCT06730906

Run by

Mayo Clinic

People needed

20

Starts

2025-01-10

Expected to finish

2026-12-31

Last updated by the study team

2026-05-18

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Anti-hyperglycemic drugs other than insulin including metformin.
• 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.
• Chronic obstructive pulmonary disease
• Asthma limiting exercise.
• 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
• 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 (glucocorticoids etc.) therapy
• COVID positive at the time of screening
• Clinically diagnosed autonomic neuropathy
• 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)
• 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 months prior to enrollment in the study
• Any known medical condition that in the judgment of the investigator might interfere with the completion of the protocol such as the following examples:

Where it is running

• Mayo Clinic in Rochester — Rochester, Minnesota, United States

Full record on ClinicalTrials.gov

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