PACTAID App for Exercise Management in Type 1 Diabetes

This study is testing the PACTAID app, a smartphone application designed to help adults with type 1 diabetes manage their blood sugar during exercise while using automated insulin delivery systems. The app provides real-time support. To join, you must be between 18 and 65 years old, have type 1 diabetes confirmed by specific blood tests (C-Peptide and fasting glucose), and be using an automated insulin delivery system like Tandem Control IQ or Omnipod 5 for at least three months. The study aims to see if the app can improve blood sugar control during and after exercise. The current recruitment status is unclear.

Study design
This study is an interventional study with two phases, enrolling up to 20 participants. It is not specified if it is randomized or blinded.
What's involved
You would use the PACTAID app for four weeks in Phase 1, then a refined version for another four weeks in Phase 2. Blood sugar levels will be measured at the start, after 4 weeks, and after 8 weeks.
Compensation
Not stated in the trial record.
Follow-up
Your blood sugar levels will be monitored for 8 weeks after starting the study.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06730906

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

Enrolling by Invitation
NAAges 18–65InterventionalDevice feasibility
Mayo Clinic
~20 participants
Updated 2026-05-18 on ClinicalTrials.gov
What's tested:PACTAID App

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Mean CGM glucose (mg/dL)
Measured over Baseline, 4 weeks, 8 weeks
+5 more outcomes measured
Type 1 Diabetes Mellitus
1 sites across 1 states
Minnesota1
  • Yogish Kudva · PRINCIPAL_INVESTIGATOR · Mayo Clinic

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

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

Exclusion

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:
  • Mean CGM glucose (mg/dL)Baseline, 4 weeks, 8 weeks

    Change in mean CGM glucose (mg/dL)

  • CGM glucose SD (mg/dL)Baseline, 4 weeks, 8 weeks

    Change in CGM glucose SD (mg/dL)

  • Glucose coefficient of variation (%)Baseline, 4 weeks, 8 weeks

    Change in glucose coefficient of variation (%)

  • CGM TIR (70-180mg/dL)Baseline, 4 weeks, 8 weeks

    Change in CGM TIR (70-180mg/dL)

  • CGM TBR (<70 and <54 mg/dL)Baseline, 4 weeks, 8 weeks

    Change in CGM TBR (\<70 and \<54 mg/dL)

  • CGM TAR (>180 and >250 mg/dL)Baseline, 4 weeks, 8 weeks

    Change in CGM TAR (\>180 and \>250 mg/dL)