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

Mayo Clinic

Status

Enrolling

Conditions

Type 1 Diabetes Mellitus

Treatments

Device: PACTAID App

Study type

Interventional

Funder types

Other

Identifiers

NCT06730906

24-007866

Details and patient eligibility

About

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.

Full description

This trial will be conducted in two phases. In Phase 1, we will test the PACTAID app in adults with type 1 diabetes mellitus to help manage exercise while on an automated insulin delivery system for four weeks. In phase 2, we will use a refined version of the PACTAID app in those same adults from phase 1 for four weeks. A 2-4-week period will be between phase 1 and phase 2 in which the app will be refined. There is one clinical site, Mayo Clinic, and two sites creating the app, Arizona State University and University of Houston. The study will enroll up to 8 subjects at Mayo Clinic.

Enrollment

20 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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