RECRUITING

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

Conditions

Type 1 Diabetes Mellitus T1D Type 1 Diabetes Exercise automated insulin delivery

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Testing and Refinement of PACTAID App in Patients with Type 1 Diabetes to Help Manage Exercise While on Automated Insulin Delivery System

Quick Facts

Study Start:2024-12-01

Study Completion:2025-12-31

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06730906

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 65 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

Corey Kurek

CONTACT

507-255-0316

reid.corey@mayo.edu

Principal Investigator

Yogish Kudva

PRINCIPAL_INVESTIGATOR

Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905

United States

Collaborators and Investigators

Sponsor: Mayo Clinic

Yogish Kudva, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-01

Study Completion Date2025-12-31

Study Record Updates

Study Start Date2024-12-01

Study Completion Date2025-12-31

Terms related to this study

Keywords Provided by Researchers

T1D
Type 1 Diabetes
Type 1 Diabetes Mellitus
Exercise
automated insulin delivery

Additional Relevant MeSH Terms

Type 1 Diabetes Mellitus