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Type 1 Diabetes MellitusPACTAIDNCT06730906

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

A study testing PACTAID App in people with Type 1 Diabetes Mellitus, run by Mayo Clinic at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
PACTAID App
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
10 Jan 2025to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 %
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  • 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

Who cannot join

  • 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
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  • 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:
  • Inpatient psychiatric treatment in the past 6 months
  • Presence of a known adrenal disorder
  • 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
  • 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.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Mayo Clinic in Rochester

    Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
PACTAID App
Keywords
T1D, Type 1 Diabetes, Type 1 Diabetes Mellitus, Exercise, automated insulin delivery
Medical subject headings
Diabetes Mellitus, Type 1, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PACTAID AppDevice

    The PACTAID app will provide real time decision support during exercise for patients with type 1 diabetes.

Study groups in NCT06730906
Study groupRoleWhat they receive
Intervention GroupExperimentalParticipants will utilize the PACTAID app for 8 weeks.
Receives: Device: PACTAID App

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Mean CGM glucose (mg/dL)

    Change in mean CGM glucose (mg/dL)

    Measured: Baseline, 4 weeks, 8 weeks

  2. CGM glucose SD (mg/dL)

    Change in CGM glucose SD (mg/dL)

    Measured: Baseline, 4 weeks, 8 weeks

  3. Glucose coefficient of variation (%)

    Change in glucose coefficient of variation (%)

    Measured: Baseline, 4 weeks, 8 weeks

  4. CGM TIR (70-180mg/dL)

    Change in CGM TIR (70-180mg/dL)

    Measured: Baseline, 4 weeks, 8 weeks

  5. CGM TBR (<70 and <54 mg/dL)

    Change in CGM TBR (<70 and <54 mg/dL)

    Measured: Baseline, 4 weeks, 8 weeks

  6. CGM TAR (>180 and >250 mg/dL)

    Change in CGM TAR (>180 and >250 mg/dL)

    Measured: Baseline, 4 weeks, 8 weeks

Secondary outcomes (7)

  1. Adherence to exercise

    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.

    Measured: Baseline, 8 weeks

  2. CGM hypoglycemic events

    Frequency of CGM measured Hypoglycemic events

    Measured: Baseline, 8 weeks

  3. Severe hypoglycemia

    Frequency of severe hypoglycemia (requiring assistance from another person to recover from hypoglycemia)

    Measured: Baseline, 8 weeks

  4. Ambulatory blood pressure

    Change in ambulatory blood pressure

    Measured: Baseline, 8 weeks

  5. Ambulatory Arterial Stiffness Index

    Change in ambulatory arterial stiffness Index

    Measured: Baseline, 8 weeks

  6. HsCRP

    Change in HsCRP

    Measured: Baseline, 8 weeks

  7. Body weight or BMI

    Change in body weight or BMI

    Measured: Baseline, 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Dec 2024
  2. Study start10 Jan 2025
  3. Primary completion28 Dec 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Device feasibility
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06730906
Sponsor's protocol ID
24-007866
Acronym
PACTAID
Status last verified
May 2026
First submitted
5 Dec 2024
Last updated
18 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing PACTAID App in people with Type 1 Diabetes Mellitus, run by Mayo Clinic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Mean CGM glucose (mg/dL) (time frame: Baseline, 4 weeks, 8 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06730906.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.

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