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

NCT06730906 | Recruiting

• 1 other identifier: 24-007866
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

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

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (7)

• Adherence to exercise

  Baseline, 8 weeks

• CGM hypoglycemic events

  Baseline, 8 weeks

• Severe hypoglycemia

  Baseline, 8 weeks

• Ambulatory blood pressure

  Baseline, 8 weeks

• Ambulatory Arterial Stiffness Index

  Baseline, 8 weeks

Other Outcomes (4)

• App confidence

  Baseline, 8 weeks

• Fear of hypoglycemia

  Baseline, 8 weeks

• Step count

  Baseline, 8 weeks

Study Arms (1)

Intervention Group

EXPERIMENTAL

Participants will utilize the PACTAID app for 8 weeks.

Device: PACTAID App

Interventions

PACTAID App DEVICE

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

Intervention Group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Arizona State University: collaborator
• University of Houston: collaborator
• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

RECRUITING

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Yogish Kudva

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Corey Kurek

CONTACT

507-255-0316; reid.corey@mayo.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 5, 2024
• First Posted: December 12, 2024
• Study Start: January 10, 2025
• Primary Completion: March 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 7, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)