Using the PACTAID app to help adults with type 1 diabetes manage exercise
Testing and Refinement of PACTAID App in Patients With Type 1 Diabetes to Help Manage Exercise While on Automated Insulin Delivery System
This study is testing a new app to help adults with type 1 diabetes manage their exercise and insulin delivery better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Mayo Clinic Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Rochester, Minnesota) |
| Trial ID | NCT06730906 on ClinicalTrials.gov |
What this trial studies
This trial aims to test and refine the PACTAID smartphone application designed for adults with type 1 diabetes mellitus to assist in managing exercise while using automated insulin delivery systems. The study will be conducted in two phases: the first phase will involve a four-week trial of the app, followed by a refinement period, and then a second four-week trial with the improved app. The goal is to enhance glycemic control during and after exercise and address various cardiovascular risk factors. The study will enroll up to 8 participants at the Mayo Clinic.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-65 with a confirmed diagnosis of type 1 diabetes using automated insulin delivery systems.
Not a fit: Patients with atherosclerotic cardiovascular disease or those using anti-hyperglycemic drugs other than insulin may not benefit from this study.
Why it matters
Potential benefit: If successful, this app could significantly improve exercise management and glycemic control for patients with type 1 diabetes.
How similar studies have performed: Other studies have shown promise in using technology to manage diabetes, but this specific approach with the PACTAID app is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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 Criteria: * 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: 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, 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 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.
Where this trial is running
Rochester, Minnesota
- Mayo Clinic in Rochester — Rochester, Minnesota, United States (Recruiting)
Study contacts
- Principal investigator: Yogish Kudva — Mayo Clinic
- Study coordinator: Corey Kurek
- Email: reid.corey@mayo.edu
- Phone: 507-255-0316
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.