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

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: Completed
• Conditions: Type 2 Diabetes Mellitus (T2DM)
• Intervention / Treatment: Behavioral: Non-Assisted Walking; Device: Bot-Fit Aqua Mode; Device: Bot-Fit Boost Mode

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: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
Incremental Area Under the Curve for Postprandial Glucose	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

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

Collaborators and Investigators

• Sponsor: CHA University
• Collaborators: Samsung Electronics
• Investigators: Principal Investigator: Seung-Bo Park, Ph.D, CHA University

Study record dates

Study Major Dates

• Study Start (Actual): March 2, 2026
• Primary Completion (Actual): May 24, 2026
• Study Completion (Actual): May 24, 2026

Study Registration Dates

• First Submitted: July 5, 2026
• First Submitted That Met QC Criteria: July 5, 2026
• First Posted (Actual): July 9, 2026

Study Record Updates

• Last Update Posted (Actual): July 9, 2026
• Last Update Submitted That Met QC Criteria: July 5, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Type 2 diabetes; Walking; Glycemic response; Postprandial glucose; Wearable hip exoskeleton; Bot-Fit
• Additional Relevant MeSH Terms: Endocrine System Diseases; Metabolic Diseases; Glucose Metabolism Disorders; Diabetes Mellitus; Nutritional and Metabolic Diseases; Diabetes Mellitus, Type 2
• Other Study ID 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