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

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: Enrolling by invitation
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Device: PACTAID App

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: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Mean CGM glucose (mg/dL)	Change in mean CGM glucose (mg/dL)	Baseline, 4 weeks, 8 weeks
CGM glucose SD (mg/dL)	Change in CGM glucose SD (mg/dL)	Baseline, 4 weeks, 8 weeks
Glucose coefficient of variation (%)	Change in glucose coefficient of variation (%)	Baseline, 4 weeks, 8 weeks
CGM TIR (70-180mg/dL)	Change in CGM TIR (70-180mg/dL)	Baseline, 4 weeks, 8 weeks
CGM TBR (<70 and <54 mg/dL)	Change in CGM TBR (<70 and <54 mg/dL)	Baseline, 4 weeks, 8 weeks
CGM TAR (>180 and >250 mg/dL)	Change in CGM TAR (>180 and >250 mg/dL)	Baseline, 4 weeks, 8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, 8 weeks
CGM hypoglycemic events	Frequency of CGM measured Hypoglycemic events	Baseline, 8 weeks
Severe hypoglycemia	Frequency of severe hypoglycemia (requiring assistance from another person to recover from hypoglycemia)	Baseline, 8 weeks
Ambulatory blood pressure	Change in ambulatory blood pressure	Baseline, 8 weeks
Ambulatory Arterial Stiffness Index	Change in ambulatory arterial stiffness Index	Baseline, 8 weeks
HsCRP	Change in HsCRP	Baseline, 8 weeks
Body weight or BMI	Change in body weight or BMI	Baseline, 8 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
App confidence	Confidence with app use during the exercise	Baseline, 8 weeks
Fear of hypoglycemia	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	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	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

• Sponsor: Mayo Clinic
• Collaborators: University of Houston; Arizona State University
• Investigators: Principal Investigator: Yogish Kudva, Mayo Clinic

Publications and helpful links

Helpful Links

• Mayo Clinic Clinical Trials

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2025
• Primary Completion (Estimated): December 28, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: December 5, 2024
• First Submitted That Met QC Criteria: December 9, 2024
• First Posted (Actual): December 12, 2024

Study Record Updates

• Last Update Posted (Actual): May 18, 2026
• Last Update Submitted That Met QC Criteria: May 15, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Exercise; Type 1 Diabetes Mellitus; Type 1 Diabetes; T1D; automated insulin delivery
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Autoimmune Diseases; Immune System Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Behavior; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 1; Motor Activity
• Other Study ID 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