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A Trial for the Use of a Pulsed Electromagnetic Field Device to Assist Management of Type 2 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04884425
Recruitment Status : Unknown
Verified May 2021 by Anne Majumdar, St Mary's University College.
Recruitment status was:  Not yet recruiting
First Posted : May 13, 2021
Last Update Posted : May 13, 2021
Sponsor:
Collaborator:
Energy5 Limited
Information provided by (Responsible Party):
Anne Majumdar, St Mary's University College

Brief Summary:

The majority of people with diabetes worldwide consist of type 2 diabetes mellitus. Typically, patients with type 2 diabetes are encouraged to manage their condition with weight loss; healthy eating; regular exercise; blood glucose monitoring; and in some cases, diabetes medication or insulin therapy. However, many struggle with their condition.

Pulsed Electromagnetic Frequency (PEMF) devices, which follow similar principles as a TENS machine, emit electromagnetic fields and are proposed to provide a non-invasive, safe, and easy-to-use method for treatment and management of diabetes related symptoms such as pain, alongside existing treatments and interventions. There is a belief that such devices may promote health and wellbeing and as a result could improve outcomes of type 2 diabetes. The use of the PEMF device would not replace existing treatments, interventions, or any primary care that the participants are currently receiving.

The purpose of this study is to evaluate the effectiveness of a PEMF device of this kind for reported symptoms such as pain, fatigue, and overall wellbeing in people with type 2 diabetes. The study also seeks to explore patients' experiences of using the PEMF device.


Condition or disease Intervention/treatment Phase
Type 2 Diabetes Device: Pulsed Electromagnetic Frequency Device (Energy5) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Consenting participants will be randomised into either the PEMF device group or the waiting list control group. There will be 30 participants in the PEMF group and 30 in the waiting list control group.
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Pilot Randomised Controlled Feasibility Trial for the Use of a Pulsed Electromagnetic Field Device to Assist Management of Type 2 Diabetes
Estimated Study Start Date : June 2021
Estimated Primary Completion Date : October 2021
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: PEMF Device Group
This arm will consist of participant's who have been randomly assigned to use the PEMF device daily for 30 mins for an overall 3 months
Device: Pulsed Electromagnetic Frequency Device (Energy5)
A pulsed electromagnetic frequency (PEMF) device which is recommended to be used for 30 minutes a day
Other Name: Energy5

No Intervention: Waiting List Control Group
These participants will be randomly selected to be on the waiting list group. All waiting list participants will be offered the use of the PEMF device after the study has completed



Primary Outcome Measures :
  1. Change in score of the Appraisal of Diabetes Scale (ADS) [ Time Frame: Baseline and at the end of the 3 months ]
    Appraisal of Diabetes Scale (ADS): The ADS is a brief 7-item patient-reported scale that assesses the impact of diabetes on a patient's life. The items, which were developed based on theory and previous research, include "How upsetting is having diabetes for you?" and "To what degree does your diabetes get in the way of your developing life goals?". The instrument has been shown to have acceptable internal consistency reliability, test-retest reliability, and construct validity. Higher scores indicate greater negative impact of diabetes.

  2. Change in Measure Yourself Medical Outcome Profile (MYMOP)2 score [ Time Frame: Baseline and at the end of the 3 months ]
    MYMOP2 is a validated questionnaire where patients can express their any two concerns and rate them

  3. Change in the EQ-5D-5L tool score [ Time Frame: Baseline and at the end of the 3 months ]
    EQ-5D-5L: Health related quality of life (HRQoL) will be measured using the EQ-5D-5L, which contains five indices to represent patients' HRQoL on the day of completing the form: mobility; self-care; usual activities; pain/discomfort; and anxiety/depression. The EQ-5D-5L also includes a visual analog scale (VAS), which records the respondent's self-rated health status on a graduated (0-100) scale, with higher scores for higher HRQoL. The EQ-5D-5L is well validated and numerous studies have used the EQ-5D-5L in a variety of patient populations, including diabetes.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Aged 18-65 years, of any gender.
  • Consulted at their general practice for type 2 diabetes in the previous 12 months.
  • Residing within England (due to delivery difficulties from covid-19).
  • Self-reported confirmed diagnosis of type 2 diabetes.
  • Self-reported stable medication regime for diabetes for at least one month.
  • Sufficient command of English to complete questionnaires.
  • Patients willing to participate in the study and be randomised into one of the two study groups.

Exclusion Criteria:

  • Patients with type 1 diabetes.
  • Patients with previous experience of using PEMF devices.
  • Patients residing outside England.
  • Patients with electronic implants such as pacemakers.
  • Patients with an electro-cardio implant.
  • Patients who have any electronic heart or lung apparatus.
  • Patients who are pregnant.
  • Patients who have a malignant tumour.
  • Patients who are receiving high-level treatment.
  • Patients who have a life-threatening illness.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04884425


Contacts
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Contact: Anne Majumdar 020 8240 2312 anne.majumdar@stmarys.ac.uk
Contact: Charlotte Foster-Brown +447899973829 charlotte.foster-brown@stmarys.ac.uk

Locations
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United Kingdom
St Marys University
Twickenham, Middlesex, United Kingdom, TW1 4SX
Contact: Anne Majumdar    020 8240 2312    anne.majumdar@stmarys.ac.uk   
Contact: Charlotte Foster-Brown    07899 973829    charlotte.foster-brown@stmarys.ac.uk   
Sponsors and Collaborators
St Mary's University College
Energy5 Limited
Investigators
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Principal Investigator: Anne Majumdar St Marys University
Publications:

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Responsible Party: Anne Majumdar, Research Administrator, St Mary's University College
ClinicalTrials.gov Identifier: NCT04884425    
Other Study ID Numbers: SMU_ETHICS_2020-21_157
First Posted: May 13, 2021    Key Record Dates
Last Update Posted: May 13, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anne Majumdar, St Mary's University College:
Pulsed Electromagnetic Frequency Device
Diabetic Pain
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases