Postprandial Glycemic and Physiological Responses to Walking With a Wearable Hip Exoskeleton in Patients With Type 2 Diabetes (Bot-Fit T2D St)

July 5, 2026 updated by: CHA University

Postprandial Glycemic and Physiological Responses to Walking With a Wearable Hip Exoskeleton in Patients With Type 2 Diabetes: A Randomized Crossover Proof-of-Concept Study

This randomized crossover proof-of-concept study evaluated the effects of walking with a wearable hip exoskeleton on postprandial glycemic and physiological responses in patients with type 2 diabetes. Participants completed four experimental conditions: seated control, walking without the wearable hip exoskeleton, walking with the Bot-Fit device in Aqua mode, and walking with the Bot-Fit device in Boost mode. The primary aim was to determine whether walking with the wearable hip exoskeleton alters postprandial glucose responses compared with seated control and conventional walking conditions in patients with type 2 diabetes.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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 study investigated whether walking with a wearable hip exoskeleton could modulate postprandial glycemic and physiological responses in patients with type 2 diabetes. Using a randomized crossover design, each participant completed four experimental conditions in a controlled laboratory setting: seated control, walking without the wearable hip exoskeleton, walking with the Bot-Fit device in Aqua mode, and walking with the Bot-Fit device in Boost mode.

Postprandial glucose responses were assessed after meal ingestion during each experimental trial. Physiological responses, including heart rate and perceived exertion, were also evaluated to compare the metabolic and perceptual demands of walking with and without the wearable hip exoskeleton. The study was designed as a proof-of-concept trial to examine whether wearable hip exoskeleton-assisted walking may influence postprandial glucose regulation in patients with type 2 diabetes.

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 (Actual)

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.
14

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 Locations

  • South Korea
    • Gyeonggi-do
      • Seongnam-si, Gyeonggi-do, South Korea, 13503
        • CHA University

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:

  • Adults diagnosed with type 2 diabetes mellitus.
  • Participants who were able to complete walking trials with and without the wearable hip exoskeleton.
  • Participants who provided written informed consent before participation.

Exclusion Criteria:

  • Participants with unstable cardiovascular, neurological, or musculoskeletal conditions that could affect walking ability or safe participation.
  • Participants with conditions that could interfere with postprandial glucose assessment.
  • Participants who were unable to safely use the wearable hip exoskeleton.
  • Participants who were unable to comply with the study procedures.

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: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover 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.
Active Comparator: Non-Assisted Walking
Participants performed 30 minutes of overground walking without wearing the Bot-Fit device.
Behavioral: Non-Assisted Walking
Participants performed 30 minutes of overground walking without wearable hip exoskeleton assistance during the postprandial period.
Experimental: Bot-Fit Aqua Mode
Participants performed 30 minutes of overground walking while wearing the Bot-Fit device in Aqua mode.
Device: Bot-Fit Aqua Mode
Participants performed 30 minutes of overground walking while wearing the Bot-Fit wearable hip exoskeleton in Aqua mode during the postprandial period.
Experimental: Bot-Fit Boost Mode
Participants performed 30 minutes of overground walking while wearing the Bot-Fit device in Boost mode.
Device: Bot-Fit Boost Mode
Participants performed 30 minutes of overground walking while wearing the Bot-Fit wearable hip exoskeleton in Boost mode during the postprandial period.

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
Incremental Area Under the Curve for Postprandial Glucose
Time Frame: Up to 120 minutes after meal ingestion during each experimental trial
Incremental area under the curve for postprandial glucose was calculated during the postprandial measurement period for each experimental condition.
Up to 120 minutes after meal ingestion during each experimental trial

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
Time Frame
Peak Postprandial Glucose Concentration
Time Frame: Up to 120 minutes after meal ingestion during each experimental trial
Up to 120 minutes after meal ingestion during each experimental trial
Heart Rate Response
Time Frame: Up to 30 minutes
Up to 30 minutes
Rating of Perceived Exertion
Time Frame: Up to 30 minutes
Up to 30 minutes

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.
CHA University

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.
Samsung Electronics

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: Seung-Bo Park, Ph.D, CHA University

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.
March 2, 2026

Primary Completion (Actual)

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.
May 24, 2026

Study Completion (Actual)

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.
May 24, 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).
July 5, 2026

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.
July 5, 2026

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.
July 9, 2026

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.
July 9, 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.
July 5, 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.
July 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.
  • BOTFIT-T2D-2025
  • S-2025-0600-000-1 (Other Grant/Funding Number: Samsung Electronics)
  • CHAMC 1044308-202503-BR-237-02 (Other Identifier: CHA University Medical Center IRB approval number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Deidentified individual participant data underlying the main results of the study may be shared upon reasonable request. The shared data may include postprandial glucose responses, heart rate, blood lactate, rating of perceived exertion, and relevant demographic and physiological variables after deidentification.

IPD Sharing Time Frame

Data may be made available beginning 6 months after publication of the main study results and for up to 3 years thereafter.

IPD Sharing Access Criteria

Data may be shared with qualified researchers who submit a reasonable research proposal to the corresponding author. Access will be granted only after review and approval by the investigators and, where required, appropriate institutional or ethics committee approval. Data will be shared only for scientific purposes and in a deidentified form.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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