Type 1 DiabetesEXTOD-ActiveNCT05706298
Active Breaks in People With Type 1 Diabetes
A study testing Active Breaks in people with Type 1 Diabetes, run by Liverpool John Moores University at 1 site in United Kingdom.
Trial summary
the investigators aim to determine the effect of 4 weeks of frequent active breaks from prolonged sitting on time in target glycaemic range in people with type 1 diabetes with high habitual sedentary behaviour. Read more about this study
- Who is it for?
- Ages 18 to 66 years
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Active Breaks
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 7 Dec 2022to 1 Aug 2024
- 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 66 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- T1D diagnosis more than 3 years ago
- Sedentary (> 10h per waking day sedentary (sitting or lying)
- Using insulin therapy with multiple daily injections or insulin pump
- Aged 18-66 (UK retirement age)
- Use of Abbot FreeStyle Libre 2 fGM (>6 weeks to avoid potential lifestyle changes as a result of sensor use)
Who cannot join
- Engaged in structured planned exercise (e.g. running, cycling, gym, or sports)
- Pregnancy or planning to become pregnant
- <6 months postpartum or stopped breastfeeding <1 month before recruitment
- Existing cerebrovascular or cardiovascular disease
- Significant history of hyperglycaemia (HbA1c >85 mmol/mol)
- History of severe hypoglycaemia requiring third party assistance within the last 3 months
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Liverpool John Moores University
Liverpool, L33AF
Matthew Cocks, PhD, 07540191292, m.s.cocks@ljmu.ac.uk
About this study
Official title: The Effect of Interrupting Sitting With Regular Active Breaks on Glycaemia and Daily Insulin Dose in Sedentary People With Type 1 Diabetes
the investigators aim to determine the effect of 4 weeks of frequent active breaks from prolonged sitting on time in target glycaemic range in people with type 1 diabetes with high habitual sedentary behaviour.
Read the detailed description
An open-label randomised controlled trial, whereby participants will complete pre-randomisation baseline procedures before allocation to 4wks of habitual activity (control) or active breaks. Interstitial glucose concentrations (fGM), insulin dose and physical activity/ postural transitions (ActivPAL) will be monitored throughout. To improve generalisability and feasibility of recruiting the required number of participants, the study will be completed in a free-living environment using remote data collection methods.
- Conditions
- Type 1 Diabetes
- Being tested
- Active Breaks
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active BreaksBehavioural
Participants will be asked to interrupt sitting with 3 min bouts of walking every 30 min from 9am-5pm
| Study group | Role | What they receive |
|---|---|---|
| Habitual lifestyle | No intervention | Participants in the control group will be asked to maintain their habitual lifestyle. |
| Active breaks | Experimental | Participants will be asked to interrupt sitting with 3 min bouts of walking every 30 min (16 bouts per day, equalling 48 min of walking) from 9am-5pm every day throughout the 4 week period. To improve adherence should participants miss a bout of walking they will be asked to do 6 min during the next bout. Receives: Behavioral: Active Breaks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in time in target glycaemic range
flash glucose monitoring
Measured: change from baseline to final week of the intervention
Secondary outcomes (16)
Change in glycaemic variability (coefficient of variation)
flash glucose monitoring
Measured: change from baseline to final week of the intervention
Change in insulin dose
Insulin dose
Measured: change from baseline to final week of the intervention
Change in Concentration of Hba1c
HbA1c
Measured: change from baseline to post intervention (4 weeks)
Change Insulin to CHO ratio
Insulin to CHO ratio
Measured: change from baseline to post intervention (4 weeks)
Change in Anxiety and depression
The Hospital Anxiety and Depression Scale (HADS)
Measured: change from baseline to post intervention (4 weeks)
Change in Diabetes Quality of Life
Diabetes Quality of Life (DQOL) questionnaire
Measured: change from baseline to post intervention (4 weeks)
Change in Health-related quality of life
Short Form-12 Health Survey (SF-12)
Measured: change from baseline to post intervention (4 weeks)
Change in Height
Height (cm)
Measured: change from baseline to post intervention (4 weeks)
Change in weight
weight (kg)
Measured: change from baseline to post intervention (4 weeks)
Change in BMI
BMI
Measured: change from baseline to post intervention (4 weeks)
Change in waist circumference
waist circumference (cm)
Measured: change from baseline to post intervention (4 weeks)
Change in triglycerides.
triglycerides.
Measured: change from baseline to post intervention (4 weeks)
Change in Insulin Sensitivity Score
LogeIS
Measured: change from baseline to post intervention (4 weeks)
c-peptide
c-peptide
Measured: baseline
Change in sedentary behaviour
minutes of sitting
Measured: change from baseline to final week of the intervention
Change in carbohydrate intake
carbohydrate intake
Measured: change from baseline to final week of the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2023
- Study start7 Dec 2022
- Primary completion1 Aug 2024 (estimated)
- Study completion1 Aug 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Type 1 DiabetesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 118 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Liverpool John Moores University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05706298
- Sponsor's protocol ID
- 22LJMUSPONSOR010
- Acronym
- EXTOD-Active
- Status last verified
- Oct 2023
- First submitted
- 21 Dec 2022
- Last updated
- 10 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jenkins JG, Cocks M, Narendran P, Andrews RC, Shields BM, Scott SN, Lucas SJE, Rendeiro C, Hesketh K. Can 4 weeks of real-world active breaks improve glycaemic management in sedentary adults with type 1 diabetes? The EXTOD-Active randomised control trial protocol. BMJ Open Sport Exerc Med. 2025 Apr 5;11(2):e002594. doi: 10.1136/bmjsem-2025-002594. eCollection 2025.
PubMed 40195972
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Interrupting Sitting With Regular Active Breaks on Glycaemia and Daily Insulin Dose in Sedentary People With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT05706298
- Acronym / sponsor ID
- EXTOD-Active / 22LJMUSPONSOR010
- Conditions
- Type 1 Diabetes
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 118 participants (estimated)
- Lead sponsor
- Liverpool John Moores UniversityUniversity, hospital or other
- Study start
- 7 Dec 2022 (actual)
- Primary completion
- 1 Aug 2024 (estimated)
- Study completion
- 1 Aug 2024 (estimated)
- First posted
- 31 Jan 2023 (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.
the investigators aim to determine the effect of 4 weeks of frequent active breaks from prolonged sitting on time in target glycaemic range in people with type 1 diabetes with high habitual sedentary behaviour.
Detailed description
An open-label randomised controlled trial, whereby participants will complete pre-randomisation baseline procedures before allocation to 4wks of habitual activity (control) or active breaks. Interstitial glucose concentrations (fGM), insulin dose and physical activity/ postural transitions (ActivPAL) will be monitored throughout. To improve generalisability and feasibility of recruiting the required number of participants, the study will be completed in a free-living environment using remote data collection methods.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Habitual lifestyle | No intervention | –Participants in the control group will be asked to maintain their habitual lifestyle. |
| Active breaks | Experimental | Behavioral: Active BreaksParticipants will be asked to interrupt sitting with 3 min bouts of walking every 30 min (16 bouts per day, equalling 48 min of walking) from 9am-5pm every day throughout the 4 week period. To improve adherence should participants miss a bout of walking they will be asked to do 6 min during the next bout. |
Who may qualify
- Ages
- 18 to 66 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- T1D diagnosis more than 3 years ago
- Sedentary (> 10h per waking day sedentary (sitting or lying)
- Using insulin therapy with multiple daily injections or insulin pump
- Aged 18-66 (UK retirement age)
- Use of Abbot FreeStyle Libre 2 fGM (>6 weeks to avoid potential lifestyle changes as a result of sensor use)
Key exclusion criteria (6 listed)
- Engaged in structured planned exercise (e.g. running, cycling, gym, or sports)
- Pregnancy or planning to become pregnant
- <6 months postpartum or stopped breastfeeding <1 month before recruitment
- Existing cerebrovascular or cardiovascular disease
- Significant history of hyperglycaemia (HbA1c >85 mmol/mol)
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 |
|---|---|---|
| Active BreaksParticipants will be asked to interrupt sitting with 3 min bouts of walking every 30 min from 9am-5pm | Behavioural | Active breaks |
Primary outcome
Change in time in target glycaemic range
Time frame: change from baseline to final week of the intervention
flash glucose monitoring
16 secondary outcomes
Change in glycaemic variability (coefficient of variation)
Time frame: change from baseline to final week of the intervention
Change in insulin dose
Time frame: change from baseline to final week of the intervention
Change in Concentration of Hba1c
Time frame: change from baseline to post intervention (4 weeks)
Change Insulin to CHO ratio
Time frame: change from baseline to post intervention (4 weeks)
Change in Anxiety and depression
Time frame: change from baseline to post intervention (4 weeks)
Change in Diabetes Quality of Life
Time frame: change from baseline to post intervention (4 weeks)
Change in Health-related quality of life
Time frame: change from baseline to post intervention (4 weeks)
Change in Height
Time frame: change from baseline to post intervention (4 weeks)
Change in weight
Time frame: change from baseline to post intervention (4 weeks)
Change in BMI
Time frame: change from baseline to post intervention (4 weeks)
Change in waist circumference
Time frame: change from baseline to post intervention (4 weeks)
Change in triglycerides.
Time frame: change from baseline to post intervention (4 weeks)
Change in Insulin Sensitivity Score
Time frame: change from baseline to post intervention (4 weeks)
c-peptide
Time frame: baseline
Change in sedentary behaviour
Time frame: change from baseline to final week of the intervention
Change in carbohydrate intake
Time frame: change from baseline to final week of the intervention
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2023.
- Derived from this study: PubMed 40195972Jenkins JG, Cocks M, Narendran P, Andrews RC, Shields BM, Scott SN, Lucas SJE, Rendeiro C, Hesketh K. Can 4 weeks of real-world active breaks improve glycaemic management in sedentary adults with type 1 diabetes? The EXTOD-Active randomised control trial protocol. BMJ Open Sport Exerc Med. 2025 Apr 5;11(2):e002594. doi: 10.1136/bmjsem-2025-002594. eCollection 2025.
- Individual participant dataSharing planned: No
Related trials for Type 1 Diabetes
Active, not recruitingPhase 3
Clinical Application of Stem Cell Educator Therapy in Type 1 Diabetes
Type 1 Diabetes
RecruitingObservational study
Study of High Density Lipoprotein Function in Type 1 Diabetic Patients With Nephropathy
Type 1 Diabetes
Active, not recruitingPhase 1/2
A First-In-Human Study of ARO-INHBE in Adults With Obesity With and Without Type 2 Diabetes Mellitus
Obesity
RecruitingPhase 3
A Study to Evaluate Effect of AZD6234 in Adult Participants With Obesity or Overweight With Weight-related Comorbidity Without Type 2 Diabetes Mellitus
Obesity or Overweight
Not yet recruitingPhase 1/2
Safety and Efficacy Evaluation of 4th Generation Safety-engineered CAR T Cells Targeting Sarcomas
Sarcoma, Osteoid Sarcoma
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active Breaks in people with Type 1 Diabetes, run by Liverpool John Moores 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 5 inclusion and 6 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 10 Oct 2023. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in time in target glycaemic range (time frame: change from baseline to final week of the intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05706298, which also lists 1 linked publication.
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 10 Oct 2023.