Diabetes Mellitus, Type 2NCT06402578
A 12-week Digital Physical Activity Programme, With or Without Physical Education Support for Type 2 Diabetes Patients.
A study testing HbA1c testing in people with Diabetes Mellitus, Type 2, run by Queen Margaret University at 1 site in United Kingdom.
Trial summary
Investigation into the effects of a 12-week digital physical activity programme, with or without physical education support on blood glucose control in patients with T2DM using HbA1c testing. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Diabetes Mellitus, Type 2
- What is being tested?
- HbA1c testing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jun 2024to Sep 2025
- 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 18 to 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- A diagnosis of T2DM in the last 3 years.
- Age 18+ years.
- Uses the English language as a primary or secondary language with the ability to read and write.
- Lives in the United Kingdom.
- Has no medical reason preventing participation in regular physical activity.
- Has a SMART phone with access to the internet.
Who cannot join
- Physical inability to participate in 12 weeks of physical activity.
- Cardiac or cardiovascular surgery in the past 6 months.
- Musculoskeletal issues that could be aggravated whilst participating in regular physical activity.
- Presently participating in a weight loss programme.
- Unable to commit to the 12-week feasibility study.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Queen Margret University Edinburgh
Edinburgh, Musselburgh, EH21 6UU
About this study
Official title: A Feasibility Randomised Controlled Trial to Investigate the Effects of a 12-week Digital Physical Activity Programme, With or Without Physical Education Support, on Blood Glucose Control in Patients With Type 2 Diabetes Mellitus
Investigation into the effects of a 12-week digital physical activity programme, with or without physical education support on blood glucose control in patients with T2DM using HbA1c testing.
Read the detailed description
Primary objective: investigate the effects of a 12-week digital physical activity programme, with or without physical education support on blood glucose control in patients with T2DM using HbA1c testing. Secondary objective: evaluate the effects on Cholesterol (ratio of High Density Lipids to Low Density Lipids), Resting Heart Rate, and Body Mass Index after a 12 week physical activity programme. Monitor step counts and sleep patterns during a 12 week physical activity programme.: Methods: Using a RCT is intended to implement dependent variable inductive research into a 12-week e-Health Physical activity (PA) programme with or without physical education support focusing on the blood glucose control in patients with T2DM. Recruitment of 60 patients from hospital out-patient clinics, community diabetic departments, and. NHS patients from general practitioners.
- Conditions
- Diabetes Mellitus, Type 2
- Being tested
- HbA1c testing
- Keywords
- HbA1c, Cholesterol, Resting Heart Rate
- 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.
HbA1c testingDiagnostic test
Bloods will be take pre and post 12 week intervention.
| Study group | Role | What they receive |
|---|---|---|
| Control Group, | No intervention | Control Group, will be issued with a smartwatch that is paired with a freely accessible App called Alexia® to record their PA. They will be asked to carry on with their daily activity and to record when they do any of their own physical activities that they do themselves routinely on an everyday basis during the 12 week study. They will not receive a 12 week PA programme. |
| Intervention 1 | Experimental | Intervention 1, will be provided with a 12 week PA programme and asked to record their PA while they follow the programme during the 12 week study. Receives: Diagnostic Test: HbA1c testing |
| Intervention 2 | Experimental | Intervention 2, will also be provided with the same 12 week PA program and asked to record their PA while they follow the programme during the 12 week study. The participants in this group will also get support from a physical activity professional (PAP) who will be monitoring their 12 week journey. The PAP will be prompting the participant with weekly information as to why they are doing these exercises as well as supporting the participants to continue their programme as soon as non-adherence to the exercise program becomes apparent during the 12 week study. Receives: Diagnostic Test: HbA1c testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
HbA1c testing
blood will be take pre and post trial.
Measured: 12 weeks
Secondary outcomes (1)
Cholesterol ratio testing
blood will be take pre and post trial.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study startJun 2024 (estimated)
- Primary completionJul 2025 (estimated)
- Study completionSep 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes Mellitus, Type 2Studies 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
- Parallel groups
- Model description
- At the point of consent the participants will be randomised to one of three allocated groups. Control group, Intervention 1 or Intervention 2.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Margaret University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Phil Calvert, Queen Margaret University
- Investigators
- Philip Calvert, MSc, Principal investigator, PhD student
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06402578
- Sponsor's protocol ID
- QMU-IRAS ID: 327162
- Status last verified
- May 2024
- First submitted
- 13 Mar 2024
- Last updated
- 7 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Randomised Controlled Trial to Investigate the Effects of a 12-week Digital Physical Activity Programme, With or Without Physical Education Support, on Blood Glucose Control in Patients With Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06402578
- Acronym / sponsor ID
- QMU-IRAS ID: 327162
- Conditions
- Diabetes Mellitus, Type 2
- Keywords
- HbA1c, Cholesterol, Resting Heart Rate
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Queen Margaret UniversityUniversity, hospital or other
- Study start
- Jun 2024 (estimated)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Sep 2025 (estimated)
- First posted
- 7 May 2024 (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.
Investigation into the effects of a 12-week digital physical activity programme, with or without physical education support on blood glucose control in patients with T2DM using HbA1c testing.
Detailed description
Primary objective: investigate the effects of a 12-week digital physical activity programme, with or without physical education support on blood glucose control in patients with T2DM using HbA1c testing. Secondary objective: evaluate the effects on Cholesterol (ratio of High Density Lipids to Low Density Lipids), Resting Heart Rate, and Body Mass Index after a 12 week physical activity programme. Monitor step counts and sleep patterns during a 12 week physical activity programme.: Methods: Using a RCT is intended to implement dependent variable inductive research into a 12-week e-Health Physical activity (PA) programme with or without physical education support focusing on the blood glucose control in patients with T2DM. Recruitment of 60 patients from hospital out-patient clinics, community diabetic departments, and. NHS patients from general practitioners.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
- Model description
- At the point of consent the participants will be randomised to one of three allocated groups. Control group, Intervention 1 or Intervention 2.
| Arm | Type | Receives |
|---|---|---|
| Control Group, | No intervention | –Control Group, will be issued with a smartwatch that is paired with a freely accessible App called Alexia® to record their PA. They will be asked to carry on with their daily activity and to record when they do any of their own physical activities that they do themselves routinely on an everyday basis during the 12 week study. They will not receive a 12 week PA programme. |
| Intervention 1 | Experimental | Diagnostic Test: HbA1c testingIntervention 1, will be provided with a 12 week PA programme and asked to record their PA while they follow the programme during the 12 week study. |
| Intervention 2 | Experimental | Diagnostic Test: HbA1c testingIntervention 2, will also be provided with the same 12 week PA program and asked to record their PA while they follow the programme during the 12 week study. The participants in this group will also get support from a physical activity professional (PAP) who will be monitoring their 12 week journey. The PAP will be prompting the participant with weekly information as to why they are doing these exercises as well as supporting the participants to continue their programme as soon as non-adherence to the exercise program becomes apparent during the 12 week study. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- A diagnosis of T2DM in the last 3 years.
- Age 18+ years.
- Uses the English language as a primary or secondary language with the ability to read and write.
- Lives in the United Kingdom.
- Has no medical reason preventing participation in regular physical activity.
Key exclusion criteria (5 listed)
- Physical inability to participate in 12 weeks of physical activity.
- Cardiac or cardiovascular surgery in the past 6 months.
- Musculoskeletal issues that could be aggravated whilst participating in regular physical activity.
- Presently participating in a weight loss programme.
- Unable to commit to the 12-week feasibility study.
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 |
|---|---|---|
| HbA1c testingBloods will be take pre and post 12 week intervention. | Diagnostic test | Intervention 1, Intervention 2 |
Primary outcome
HbA1c testing
Time frame: 12 weeks
blood will be take pre and post trial.
1 secondary outcome
Cholesterol ratio testing
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
- Individual participant dataSharing planned: Undecided
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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.
Philip Calvert, MSc principal investigator
PhD student
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing HbA1c testing in people with Diabetes Mellitus, Type 2, run by Queen Margaret University at 1 site in United Kingdom.
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 6 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 7 May 2024. 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 United Kingdom. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philip Calvert, MSc (0131 474 0000, PCalvert@qmu.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HbA1c testing (time frame: 12 weeks). 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 7 May 2024; AzTrials last refreshed its copy on 28 Oct 2026.