Type 1 Diabetes Mellitus
Conditions
Keywords
T1D, Type 1 Diabetes, Type 1 Diabetes Mellitus, Exercise, automated insulin delivery
Brief summary
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.
Detailed 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.
Interventions
DEVICEPACTAID App
The PACTAID app will provide real time decision support during exercise for patients with type 1 diabetes.
Sponsors
Mayo Clinic
Arizona State University
University of Houston
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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/
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adherence to exercise | Baseline, 8 weeks | Data will be collected via the PACTAID app, which will generate reports on the number of exercise sessions logged by patients. Since participants will also be wearing a Fitbit watch, we will capture heart rate changes during exercise, which will help confirm their physical activity. Furthermore, participants will complete the International Physical Activity Questionnaire (IPAQ) approximately once a month throughout the study. |
| CGM hypoglycemic events | Baseline, 8 weeks | Frequency of CGM measured Hypoglycemic events |
| Severe hypoglycemia | Baseline, 8 weeks | Frequency of severe hypoglycemia (requiring assistance from another person to recover from hypoglycemia) |
| Ambulatory blood pressure | Baseline, 8 weeks | Change in ambulatory blood pressure |
| Ambulatory Arterial Stiffness Index | Baseline, 8 weeks | Change in ambulatory arterial stiffness Index |
| HsCRP | Baseline, 8 weeks | Change in HsCRP |
| Body weight or BMI | Baseline, 8 weeks | Change in body weight or BMI |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORYogish Kudva
Mayo Clinic
Outcome results
None listed