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

May 15, 2026 updated by: Yogish C. Kudva, Mayo Clinic

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Enrolling by invitation

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

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.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Intervention Group
Participants will utilize the PACTAID app for 8 weeks.
Device: PACTAID App
The PACTAID app will provide real time decision support during exercise for patients with type 1 diabetes.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Mean CGM glucose (mg/dL)
Time Frame: Baseline, 4 weeks, 8 weeks
Change in mean CGM glucose (mg/dL)
Baseline, 4 weeks, 8 weeks
CGM glucose SD (mg/dL)
Time Frame: Baseline, 4 weeks, 8 weeks
Change in CGM glucose SD (mg/dL)
Baseline, 4 weeks, 8 weeks
Glucose coefficient of variation (%)
Time Frame: Baseline, 4 weeks, 8 weeks
Change in glucose coefficient of variation (%)
Baseline, 4 weeks, 8 weeks
CGM TIR (70-180mg/dL)
Time Frame: Baseline, 4 weeks, 8 weeks
Change in CGM TIR (70-180mg/dL)
Baseline, 4 weeks, 8 weeks
CGM TBR (<70 and <54 mg/dL)
Time Frame: Baseline, 4 weeks, 8 weeks
Change in CGM TBR (<70 and <54 mg/dL)
Baseline, 4 weeks, 8 weeks
CGM TAR (>180 and >250 mg/dL)
Time Frame: Baseline, 4 weeks, 8 weeks
Change in CGM TAR (>180 and >250 mg/dL)
Baseline, 4 weeks, 8 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Adherence to exercise
Time Frame: 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.
Baseline, 8 weeks
CGM hypoglycemic events
Time Frame: Baseline, 8 weeks
Frequency of CGM measured Hypoglycemic events
Baseline, 8 weeks
Severe hypoglycemia
Time Frame: Baseline, 8 weeks
Frequency of severe hypoglycemia (requiring assistance from another person to recover from hypoglycemia)
Baseline, 8 weeks
Ambulatory blood pressure
Time Frame: Baseline, 8 weeks
Change in ambulatory blood pressure
Baseline, 8 weeks
Ambulatory Arterial Stiffness Index
Time Frame: Baseline, 8 weeks
Change in ambulatory arterial stiffness Index
Baseline, 8 weeks
HsCRP
Time Frame: Baseline, 8 weeks
Change in HsCRP
Baseline, 8 weeks
Body weight or BMI
Time Frame: Baseline, 8 weeks
Change in body weight or BMI
Baseline, 8 weeks

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
App confidence
Time Frame: Baseline, 8 weeks
Confidence with app use during the exercise
Baseline, 8 weeks
Fear of hypoglycemia
Time Frame: Baseline, 8 weeks
The severity of hypoglycemia will be assessed monthly using the Clarke Hypoglycemia Unawareness Questionnaire. Additionally, participants will have the opportunity to add comments in the app before or after exercise sessions to indicate if they chose not to exercise due to concerns about hypoglycemia.
Baseline, 8 weeks
Step count
Time Frame: Baseline, 8 weeks
Step count will be assessed by a FitBit. We will assess the correlation of step count on CGM glucose metrics (TIR, TAR and TBR)
Baseline, 8 weeks
Heart rate
Time Frame: Baseline, 8 weeks
Heart rate will be assessed by a Fitbit. We will assess heart rate to determine if there is a relationship between CGM glucose metrics (TIR, TAR and TBR).
Baseline, 8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Mayo Clinic

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Houston
Arizona State University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Yogish Kudva, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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 Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 10, 2025

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 28, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 5, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 9, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 12, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 18, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 24-007866

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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