Clinical trial NCT06730906: PACTAID App in Adults With Type 1 Diabetes to Help Manage Exercise
Official title: Testing and Refinement of PACTAID App in Patients With Type 1 Diabetes to Help Manage Exercise While on Automated Insulin Delivery System
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: T1D
Type 1 Diabetes
Type 1 Diabetes Mellitus
Exercise
automated insulin delivery
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: Arizona State University
name: University of Houston
First posted: 2024-12-12
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility 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.

Primary outcomes:
measure: Mean CGM glucose (mg/dL)
timeFrame: Baseline, 4 weeks, 8 weeks
measure: CGM glucose SD (mg/dL)
timeFrame: Baseline, 4 weeks, 8 weeks
measure: Glucose coefficient of variation (%)
timeFrame: Baseline, 4 weeks, 8 weeks
measure: CGM TIR (70-180mg/dL)
timeFrame: Baseline, 4 weeks, 8 weeks
measure: CGM TBR (<70 and <54 mg/dL)
timeFrame: Baseline, 4 weeks, 8 weeks
measure: CGM TAR (>180 and >250 mg/dL)
timeFrame: Baseline, 4 weeks, 8 weeks
Secondary outcomes:
measure: Adherence to exercise
timeFrame: Baseline, 8 weeks
measure: CGM hypoglycemic events
timeFrame: Baseline, 8 weeks
measure: Severe hypoglycemia
timeFrame: Baseline, 8 weeks
measure: Ambulatory blood pressure
timeFrame: Baseline, 8 weeks
measure: Ambulatory Arterial Stiffness Index
timeFrame: Baseline, 8 weeks
measure: HsCRP
timeFrame: Baseline, 8 weeks
measure: Body weight or BMI
timeFrame: Baseline, 8 weeks
Other outcomes:
measure: App confidence
timeFrame: Baseline, 8 weeks
measure: Fear of hypoglycemia
timeFrame: Baseline, 8 weeks
measure: Step count
timeFrame: Baseline, 8 weeks
measure: Heart rate
timeFrame: Baseline, 8 weeks
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Yogish Kudva
role: PRINCIPAL_INVESTIGATOR
References: