Type 2 Diabetes Mellitus (T2DM)Bot-Fit T2D StNCT07692802
Postprandial Glycemic and Physiological Responses to Walking With a Wearable Hip Exoskeleton in Patients With Type 2 Diabetes
A study testing Bot-Fit Aqua Mode, Bot-Fit Boost Mode and Non-Assisted Walking in people with Type 2 Diabetes Mellitus (T2DM), run by CHA University at 1 site in South Korea.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 55 to 75 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM)
- What is being tested?
- Bot-Fit Aqua Mode, Bot-Fit Boost Mode and Non-Assisted Walking
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteSouth Korea
- Study dates
- 2 Mar 2026to 24 May 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 55 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Being tested
- Bot-Fit Aqua Mode, Bot-Fit Boost Mode, Non-Assisted Walking
- Keywords
- Wearable hip exoskeleton, Bot-Fit, Type 2 diabetes, Postprandial glucose, Glycemic response, Walking
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bot-Fit Aqua ModeDevice
Participants performed 30 minutes of overground walking while wearing the Bot-Fit wearable hip exoskeleton in Aqua mode during the postprandial period.
Bot-Fit Boost ModeDevice
Participants performed 30 minutes of overground walking while wearing the Bot-Fit wearable hip exoskeleton in Boost mode during the postprandial period.
Non-Assisted WalkingBehavioural
Participants performed 30 minutes of overground walking without wearable hip exoskeleton assistance during the postprandial period.
| Study group | Role | What they receive |
|---|---|---|
| Non-Assisted Walking | Active comparator | Participants performed 30 minutes of overground walking without wearing the Bot-Fit device. Receives: Behavioral: Non-Assisted Walking |
| Bot-Fit Aqua Mode | Experimental | Participants performed 30 minutes of overground walking while wearing the Bot-Fit device in Aqua mode. Receives: Device: Bot-Fit Aqua Mode |
| Bot-Fit Boost Mode | Experimental | Participants performed 30 minutes of overground walking while wearing the Bot-Fit device in Boost mode. Receives: Device: Bot-Fit Boost Mode |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 120 minutes after meal ingestion during each experimental trial
Secondary outcomes (3)
Peak Postprandial Glucose Concentration
Measured: Up to 120 minutes after meal ingestion during each experimental trial
Heart Rate Response
Measured: Up to 30 minutes
Rating of Perceived Exertion
Measured: Up to 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2026
- Study start2 Mar 2026
- Primary completion24 May 2026
- Study completion24 May 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant completed four experimental conditions in a randomized crossover design: 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.
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHA University
- Sponsor type
- University, hospital or other
- Collaborators
- Samsung Electronics
- Responsible party
- Sponsor
- Investigators
- Seung-Bo Park, Ph.D, Principal investigator, CHA University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07692802
- Sponsor's protocol ID
- BOTFIT-T2D-2025
- Other IDs
- S-2025-0600-000-1, CHAMC 1044308-202503-BR-237-02
- Acronym
- Bot-Fit T2D St
- Status last verified
- Jul 2026
- First submitted
- 5 Jul 2026
- Last updated
- 9 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07692802
- Acronym / sponsor ID
- Bot-Fit T2D St / BOTFIT-T2D-2025
- Conditions
- Type 2 Diabetes Mellitus (T2DM)
- Keywords
- Wearable hip exoskeleton, Bot-Fit, Type 2 diabetes, Postprandial glucose, Glycemic response, Walking
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- CHA UniversityUniversity, hospital or other
- Collaborators
- Samsung Electronics
- Study start
- 2 Mar 2026 (actual)
- Primary completion
- 24 May 2026 (actual)
- Study completion
- 24 May 2026 (actual)
- First posted
- 9 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Each participant completed four experimental conditions in a randomized crossover design: 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.
| Arm | Type | Receives |
|---|---|---|
| Non-Assisted Walking | Active comparator | Behavioral: Non-Assisted WalkingParticipants performed 30 minutes of overground walking without wearing the Bot-Fit device. |
| Bot-Fit Aqua Mode | Experimental | Device: Bot-Fit Aqua ModeParticipants performed 30 minutes of overground walking while wearing the Bot-Fit device in Aqua mode. |
| Bot-Fit Boost Mode | Experimental | Device: Bot-Fit Boost ModeParticipants performed 30 minutes of overground walking while wearing the Bot-Fit device in Boost mode. |
Who may qualify
- Ages
- 55 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bot-Fit Aqua ModeParticipants performed 30 minutes of overground walking while wearing the Bot-Fit wearable hip exoskeleton in Aqua mode during the postprandial period. | Device | Bot-Fit Aqua Mode |
| Bot-Fit Boost ModeParticipants performed 30 minutes of overground walking while wearing the Bot-Fit wearable hip exoskeleton in Boost mode during the postprandial period. | Device | Bot-Fit Boost Mode |
| Non-Assisted WalkingParticipants performed 30 minutes of overground walking without wearable hip exoskeleton assistance during the postprandial period. | Behavioural | Non-Assisted Walking |
Primary outcome
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.
3 secondary outcomes
Peak Postprandial Glucose Concentration
Time frame: Up to 120 minutes after meal ingestion during each experimental trial
Heart Rate Response
Time frame: Up to 30 minutes
Rating of Perceived Exertion
Time frame: Up to 30 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Seung-Bo Park, Ph.D principal investigator
CHA University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bot-Fit Aqua Mode, Bot-Fit Boost Mode and Non-Assisted Walking in people with Type 2 Diabetes Mellitus (T2DM), run by CHA University at 1 site in South Korea.
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 3 inclusion and 4 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: finished, as of the sponsor's last update on 9 Jul 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 South Korea. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Incremental Area Under the Curve for Postprandial Glucose (time frame: Up to 120 minutes after meal ingestion during each experimental trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Jul 2026.