Heat Therapy for Type 2 Diabetes
This study is testing whether a home-based heat therapy system can improve the health of older adults with Type 2 Diabetes (T2D). T2D can lead to serious health problems, and while exercise helps, it can be difficult for some. This study explores if daily heat therapy using special leg sleeves, for 90 minutes over 12 weeks, can offer similar benefits. You might be able to join if you are 55 or older and have T2D, with specific blood sugar levels (HbA1c between 6.5% and 9.0%). The main goal is to see if this heat therapy is safe and easy to use at home. This study is currently recruiting 24 participants.
- Study design
- This is a randomized, sham-controlled study involving 24 participants. It aims to establish the feasibility, acceptability, and safety of home-based leg heat therapy.
- What's involved
- Participants will apply the heat therapy or a sham treatment daily for 90 minutes using water-circulating leg sleeves over 12 weeks. The study will assess compliance, completion rates, and device safety.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed from enrollment to the end of treatment at 12 weeks.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Heat Therapy in Type 2 Diabetes
At a glance
Conditions
Where it's being run
1 sites across 1 statesWho to contact
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What this trial measures
- ComplianceFrom enrollment to the end of treatment at 12 weeks
A built-in timer inside the pump that is inaccessible to participants will provide one assessment of patient compliance with the therapy. Compliance will be determined by dividing the number of hours of HT recorded use by the required hours. In addition, patients in both groups will receive a logbook to record their treatment sessions.
- Completion rateFrom enrollment to the end of treatment at 12 weeks
Completion rates will be defined as the number of patients attending the follow-up assessments.
- SafetyFrom enrollment to the end of treatment at 12 weeks
The study coordinator will call patients weekly to record the occurrence of symptoms, such as faintness or dizziness after exposure to the therapy, and changes in medical status . Adverse events (AEs) will be tracked throughout the study and used as a surrogate for safety-related outcomes.