Diabetes Mellitus, Type 1NCT03144869
Physical Activity Monitoring Paediatric Type 1 Diabetes
A study testing physical activity monitor and feedback in people with Diabetes Mellitus, Type 1, run by Sheffield Hallam University at 1 site in United Kingdom.
Trial summary
Physical activity (PA) can have positive health outcomes for children with type 1 diabetes (T1DM), yet being physically active can have unwanted side effects due to fluctuations in blood glucose (BG) level. Read more about this study
- Who is it for?
- Ages 7 to 11 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- physical activity monitor and feedback
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Sep 2017to 1 Aug 2018
- 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 7 to 11 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Arm 1 Children with type 1 diabetes Aged 7-11 years (age range may be increased to 6-12 years if recruitment is problematic) Diagnosed with type 1 diabetes for at least 12 months Consenting primary caregiver Willingness of child and parent for the child to wear activity monitor
- Arm 2 Children with type 1 diabetes using a personal CGM OR CGM on loan from clinic as part of clinical care Aged 7-11 years (age range may be increased to 6-12 years if recruitment is problematic) Diagnosed with type 1 diabetes for at least 12 months Consenting primary caregiver Willingness of child and parent for the child to wear an activity monitor
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Sheffield Children's Hospital NHS Foundation Trust
Sheffield
About this study
Official title: Feasibility and Acceptability of Physical Activity Monitoring as an Educational Tool in the Management of Paediatric Type 1 Diabetes
Physical activity (PA) can have positive health outcomes for children with type 1 diabetes (T1DM), yet being physically active can have unwanted side effects due to fluctuations in blood glucose (BG) level. Children and parents need support to help understand the relationship between PA and BG level, and how to use PA as a vehicle to better manage the condition. Using PA monitoring could help HCPs raise awareness about PA, discuss PA and facilitate diabetes management. This research will explore the feasibility and acceptability of PA monitoring as a clinical tool to help the management of paediatric T1DM.
Read the detailed description
Physical activity (PA) can have positive health outcomes for children with type 1 diabetes (T1DM) such as improved diabetes control, lipid profile and body composition, yet activity levels are low. The unpredictable nature of children's everyday activity causes fluctuations in blood glucose (BG) level. Low and high BG level are side-effects of PA, have significant symptoms and can cause a range of chronic complications. Parents typically have responsibility for diabetes management in preadolescent children and perceive PA as a challenge due to constant concerns about BG levels (Quirk et al., 2015).
Children and parents need support to help understand the relationship between PA and BG control and how to use PA as a vehicle through which to better manage the condition. T1DM healthcare professionals (HCPs) perceive a lack of i) competence, ii) confidence and iii) time to provide PA advice and education in the clinical setting. HCPs perceive a need for evidence-based resources to facilitate PA discussion, education and promotion (Quirk et al., 2015). Physical activity monitoring is already a widely recognised and accepted tool, with potential utility in paediatric diabetes.
One such approach could be that HCPs graphically convey children's PA levels and use this to raise awareness and promote discussion about daily PA level. In those using constant glucose monitoring devices, daily BG values could be graphically documented to help explain the relationship between PA and BG level. These devices have shown acceptability among children with T1DM. However, whether they can facilitate PA discussion and education is unknown.
This research will explore parents, children and HCPs' perceptions of PA monitoring in clinical practice. A PA monitoring programme will be developed, implemented in a small cohort of children with T1DM and evaluated for feasibility and acceptability. In the future, 'physical activity clinical champions' could be trained to use activity monitoring for PA education and promotion in clinic settings.
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- physical activity monitor and feedback
- Keywords
- type 1 diabetes mellitus, physical activity, children, constant glucose monitoring
- Medical subject headings
- Diabetes Mellitus, Type 1, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physical activity monitor and feedbackBehavioural
Children will wear a Runscribe accelerometer for two weeks (children in Arm 2 will also wear a CGM). Runscribe will measure activity levels. Activity data will be downloaded by a researcher, analysed and graphs of daily activity levels prepared. At the child's next routine clinic appointment, child and parent will have 1:1 session with researcher acting as 'physical activity champion'. Session content will be informed by Phase 1, but will involve educational support around PA (including barriers and facilitators to participation) and individualised feedback on PA level). Individualised feedback will involve review of daily PA graphs - addressing times of high and low activity levels. For participants in Arm 2, there will also be review of daily line graphs showing BG trends. As part of standard clinical care, CGM data gets downloaded at routine clinic appointments and is visible on the patient's clinic notes in daily graph form.
| Study group | Role | What they receive |
|---|---|---|
| physical activity monitor only | Experimental | Children will wear a Runscribe accelerometer for two weeks. Runscribe is a small inertial sensor (weight 15g, size 35x25x7.5 mm). It can be attached to the body in several positions (wrist, waist, sacrum, chest, thigh, foot) and is used for monitoring movement. Runscribe does not beep, flash or have a visual display. It will not provide PA feedback to the individuals in real-time, only via a researcher after the data has been downloaded. In this study, we are not wishing to influence children's behaviour by providing PA feedback in real-time. We are trying to establish whether PA monitoring is feasible and acceptable - and further research could go on to explore the use of real-time PA feedback as an educational technique.
Phase 1 findings will help to determine: i) method of monitor distribution to participants (post, clinic or in-person), ii) preferred wear position. Receives: Behavioral: physical activity monitor and feedback |
| physical activity monitor plus constant glucose monitor | Experimental | Children using a personal constant glucose monitor (CGM) or CGM on loan from clinic as part of clinical care will be approached for Arm 2. These children will wear Runscribe at the same time as a CGM. Runscribe and CGM worn over the same 2 week period. Receives: Behavioral: physical activity monitor and feedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment
Recruitment will be recorded during the recruitment period as the number of eligible participants that consented to participate. The following data will be assessed: number meeting eligibility criteria, reasons for ineligibility, number consenting and reasons for non-participation; demographic profile of participating and nonparticipating (e.g., to assess inclusion of ethnic minority and hard-to-reach groups), and withdrawals (with reasons where available).
Measured: During recruitment (0 months)
Adherence
Adherence will refer to the proportion of participants who adhere to the activity monitoring protocol (meet the valid wear-time protocol) and proportion of participants who attend all scheduled activity monitoring sessions with the researcher. Adherence will be monitored by the researcher at baseline, follow-up and throughout the intervention.
Measured: At follow-up (~3 months)
Retention
Retention rate will be defined as the number of participants completing the intervention, including all follow-up data collection (follow-up and interview) compared to the number started. Retention will be recorded by the researcher at follow-up and interview.
Measured: At follow-up (~3 months)
Data completion
Data completion rate is determined by recording the proportion of participants who complete the outcome measures at baseline and follow-up. To assess data completion, completion of questionnaire measures will be recorded at baseline and follow-up (complete and partial or non-completion with reasons, time to complete). The feasibility of gathering routinely collected data available in patients' clinic notes at baseline and follow-up will be assessed. Feasibility of collecting observational data in this way will be determined if >85% of our sample have complete clinical records available. Data completion will be recorded by the researcher at baseline and follow-up.
Measured: At baseline (0 months) and follow-up (~3 months)
Occurrence of adverse events
ccurrence of adverse events related to the intervention (e.g., severe hypoglycaemia, accident or injury) will be assessed by reviewing patient notes and patient self-report.
Measured: At baseline (0 months), during intervention (0-3 months) and at follow-up (~3 months)
Acceptability
User acceptability of research and intervention processes will be assessed by interview with children and parents. Interviews will explore acceptability of i) recruitment, ii) outcome measures, iii) participant burden, iv) the activity monitor and v) feedback sessions to determine appropriateness of the intervention for use in a future trial and clinical practice. Interviews will explore perceptions of change. Interviews will be conducted by a member of the research team who is experienced in qualitative research and who, ideally, has had no direct involvement with the intervention implementation.
Measured: At follow-up (~3 months)
Secondary outcomes (4)
Demographics
A questionnaire developed specifically for this study that asks parents to report: child's age, child's ethnic background, use of glucometer/constant glucose monitor, method of insulin delivery, parental occupation, parental education, and total family income per year.
Measured: At baseline (0 months)
Clinical information
Clinical information will be collected from the participant's electronic clinic notes. These data collection methods are non-invasive (glycaemic control, insulin dosage, height and weight measurements - measured as routine at every clinic appointment- will be taken from the child's clinic notes, with permission). The researcher will ask clerical staff at the participating centre to complete a spreadsheet with the information for each consenting participant at baseline and follow-up. Data extracted will include: Height, Weight, Glycaemic control (HbA1c), Insulin dosage, Frequency of severe hypoglycaemia, Method of insulin delivery. This data is measured by trained nurses as standard at all routine clinic appointments. The researcher will ask for the data collected at the corresponding clinic appointment.
Measured: At baseline (0 months) and follow-up (~3 months)
Parental self-efficacy for diabetes management
Parental self-efficacy for diabetes management will be assessed using the self-efficacy for diabetes scale (Streisand et al., 2005). It contains 22 parenting tasks associated with diabetes management, and parents rate their confidence with performing each task on a 5-point scale (1-Very sure I can't to 5-Very sure I can), indicating how much they believe they can or cannot do what is asked now. Higher scores indicate greater parental self-efficacy.
Measured: At baseline (0 months) and follow-up (~3 months)
Parental fear of hypoglycaemia
Parental fear of hypoglycaemia will be assessed using the parents' Hypoglycemia Fear Survey (PHFS) (Gonder-Frederick et al., 2011). The PHFS is comprised of a 10-item behaviour (B) subscale and a 15-item worry (W) subscale. Higher scores indicate greater fear of hypoglycaemia. HFS-B items describe behaviours performed in order to avoid hypoglycaemic episodes and/or their negative consequences (e.g., by limiting exercise or physical activity). HFS-W items ask about specific concerns about hypoglycaemic episodes (e.g., episodes occurring during sleep, or having an accident). Higher scores indicate greater fear of hypoglycaemia. Research shows that the PHFS can provide reliable self-report of parental fear of hypoglycaemia (Gonder-Frederick et al., 2011). It also asks parents to report the number of severe hypoglycaemia episodes their child has experienced in the past 12 months.
Measured: At baseline (0 months) and follow-up (~3 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2017
- Study start1 Sep 2017
- Primary completion1 Aug 2018
- Study completion1 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sheffield Hallam University
- Sponsor type
- University, hospital or other
- Collaborators
- Sheffield Children's NHS Foundation Trust
- Responsible party
- Principal investigator, Helen Quirk, Sheffield Hallam University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03144869
- Sponsor's protocol ID
- CA16015
- Status last verified
- Sep 2018
- First submitted
- 5 May 2017
- Last updated
- 6 Sep 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Streisand R, Swift E, Wickmark T, Chen R, Holmes CS. Pediatric parenting stress among parents of children with type 1 diabetes: the role of self-efficacy, responsibility, and fear. J Pediatr Psychol. 2005 Sep;30(6):513-21. doi: 10.1093/jpepsy/jsi076. Epub 2005 Mar 3.
PubMed 16055489Gonder-Frederick L, Nyer M, Shepard JA, Vajda K, Clarke W. Assessing fear of hypoglycemia in children with Type 1 diabetes and their parents. Diabetes Manag (Lond). 2011;1(6):627-639. doi: 10.2217/DMT.11.60.
PubMed 22180760
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of Physical Activity Monitoring as an Educational Tool in the Management of Paediatric Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT03144869
- Acronym / sponsor ID
- CA16015
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- type 1 diabetes mellitus, physical activity, children, constant glucose monitoring
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Sheffield Hallam UniversityUniversity, hospital or other
- Collaborators
- Sheffield Children's NHS Foundation Trust
- Study start
- 1 Sep 2017 (actual)
- Primary completion
- 1 Aug 2018 (actual)
- Study completion
- 1 Aug 2018 (actual)
- First posted
- 9 May 2017 (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.
Physical activity (PA) can have positive health outcomes for children with type 1 diabetes (T1DM), yet being physically active can have unwanted side effects due to fluctuations in blood glucose (BG) level. Children and parents need support to help understand the relationship between PA and BG level, and how to use PA as a vehicle to better manage the condition. Using PA monitoring could help HCPs raise awareness about PA, discuss PA and facilitate diabetes management. This research will explore the feasibility and acceptability of PA monitoring as a clinical tool to help the management of paediatric T1DM.
Detailed description
Physical activity (PA) can have positive health outcomes for children with type 1 diabetes (T1DM) such as improved diabetes control, lipid profile and body composition, yet activity levels are low. The unpredictable nature of children's everyday activity causes fluctuations in blood glucose (BG) level. Low and high BG level are side-effects of PA, have significant symptoms and can cause a range of chronic complications. Parents typically have responsibility for diabetes management in preadolescent children and perceive PA as a challenge due to constant concerns about BG levels (Quirk et al., 2015).
Children and parents need support to help understand the relationship between PA and BG control and how to use PA as a vehicle through which to better manage the condition. T1DM healthcare professionals (HCPs) perceive a lack of i) competence, ii) confidence and iii) time to provide PA advice and education in the clinical setting. HCPs perceive a need for evidence-based resources to facilitate PA discussion, education and promotion (Quirk et al., 2015). Physical activity monitoring is already a widely recognised and accepted tool, with potential utility in paediatric diabetes.
One such approach could be that HCPs graphically convey children's PA levels and use this to raise awareness and promote discussion about daily PA level. In those using constant glucose monitoring devices, daily BG values could be graphically documented to help explain the relationship between PA and BG level. These devices have shown acceptability among children with T1DM. However, whether they can facilitate PA discussion and education is unknown.
This research will explore parents, children and HCPs' perceptions of PA monitoring in clinical practice. A PA monitoring programme will be developed, implemented in a small cohort of children with T1DM and evaluated for feasibility and acceptability. In the future, 'physical activity clinical champions' could be trained to use activity monitoring for PA education and promotion in clinic settings.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| physical activity monitor only | Experimental | Behavioral: physical activity monitor and feedbackChildren will wear a Runscribe accelerometer for two weeks. Runscribe is a small inertial sensor (weight 15g, size 35x25x7.5 mm). It can be attached to the body in several positions (wrist, waist, sacrum, chest, thigh, foot) and is used for monitoring movement. Runscribe does not beep, flash or have a visual display. It will not provide PA feedback to the individuals in real-time, only via a researcher after the data has been downloaded. In this study, we are not wishing to influence children's behaviour by providing PA feedback in real-time. We are trying to establish whether PA monitoring is feasible and acceptable - and further research could go on to explore the use of real-time PA feedback as an educational technique. Phase 1 findings will help to determine: i) method of monitor distribution to participants (post, clinic or in-person), ii) preferred wear position. |
| physical activity monitor plus constant glucose monitor | Experimental | Behavioral: physical activity monitor and feedbackChildren using a personal constant glucose monitor (CGM) or CGM on loan from clinic as part of clinical care will be approached for Arm 2. These children will wear Runscribe at the same time as a CGM. Runscribe and CGM worn over the same 2 week period. |
Who may qualify
- Ages
- 7 to 11 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Arm 1 Children with type 1 diabetes Aged 7-11 years (age range may be increased to 6-12 years if recruitment is problematic) Diagnosed with type 1 diabetes for at least 12 months Consenting primary caregiver Willingness of child and parent for the child to wear activity monitor
- Arm 2 Children with type 1 diabetes using a personal CGM OR CGM on loan from clinic as part of clinical care Aged 7-11 years (age range may be increased to 6-12 years if recruitment is problematic) Diagnosed with type 1 diabetes for at least 12 months Consenting primary caregiver Willingness of child and parent for the child to wear an activity monitor
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| physical activity monitor and feedbackChildren will wear a Runscribe accelerometer for two weeks (children in Arm 2 will also wear a CGM). Runscribe will measure activity levels. Activity data will be downloaded by a researcher, analysed and graphs of daily activity levels prepared. At the child's next routine clinic appointment, child and parent will have 1:1 session with researcher acting as 'physical activity champion'. Session content will be informed by Phase 1, but will involve educational support around PA (including barriers and facilitators to participation) and individualised feedback on PA level). Individualised feedback will involve review of daily PA graphs - addressing times of high and low activity levels. For participants in Arm 2, there will also be review of daily line graphs showing BG trends. As part of standard clinical care, CGM data gets downloaded at routine clinic appointments and is visible on the patient's clinic notes in daily graph form. | Behavioural | physical activity monitor only, physical activity monitor plus constant glucose monitor |
Primary outcome
Recruitment
Time frame: During recruitment (0 months)
Recruitment will be recorded during the recruitment period as the number of eligible participants that consented to participate. The following data will be assessed: number meeting eligibility criteria, reasons for ineligibility, number consenting and reasons for non-participation; demographic profile of participating and nonparticipating (e.g., to assess inclusion of ethnic minority and hard-to-reach groups), and withdrawals (with reasons where available).
Adherence
Time frame: At follow-up (~3 months)
Adherence will refer to the proportion of participants who adhere to the activity monitoring protocol (meet the valid wear-time protocol) and proportion of participants who attend all scheduled activity monitoring sessions with the researcher. Adherence will be monitored by the researcher at baseline, follow-up and throughout the intervention.
Retention
Time frame: At follow-up (~3 months)
Retention rate will be defined as the number of participants completing the intervention, including all follow-up data collection (follow-up and interview) compared to the number started. Retention will be recorded by the researcher at follow-up and interview.
Data completion
Time frame: At baseline (0 months) and follow-up (~3 months)
Data completion rate is determined by recording the proportion of participants who complete the outcome measures at baseline and follow-up. To assess data completion, completion of questionnaire measures will be recorded at baseline and follow-up (complete and partial or non-completion with reasons, time to complete). The feasibility of gathering routinely collected data available in patients' clinic notes at baseline and follow-up will be assessed. Feasibility of collecting observational data in this way will be determined if >85% of our sample have complete clinical records available. Data completion will be recorded by the researcher at baseline and follow-up.
Occurrence of adverse events
Time frame: At baseline (0 months), during intervention (0-3 months) and at follow-up (~3 months)
ccurrence of adverse events related to the intervention (e.g., severe hypoglycaemia, accident or injury) will be assessed by reviewing patient notes and patient self-report.
Acceptability
Time frame: At follow-up (~3 months)
User acceptability of research and intervention processes will be assessed by interview with children and parents. Interviews will explore acceptability of i) recruitment, ii) outcome measures, iii) participant burden, iv) the activity monitor and v) feedback sessions to determine appropriateness of the intervention for use in a future trial and clinical practice. Interviews will explore perceptions of change. Interviews will be conducted by a member of the research team who is experienced in qualitative research and who, ideally, has had no direct involvement with the intervention implementation.
4 secondary outcomes
Demographics
Time frame: At baseline (0 months)
Clinical information
Time frame: At baseline (0 months) and follow-up (~3 months)
Parental self-efficacy for diabetes management
Time frame: At baseline (0 months) and follow-up (~3 months)
Parental fear of hypoglycaemia
Time frame: At baseline (0 months) and follow-up (~3 months)
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 6 Sep 2018.
- Background: PubMed 16055489Streisand R, Swift E, Wickmark T, Chen R, Holmes CS. Pediatric parenting stress among parents of children with type 1 diabetes: the role of self-efficacy, responsibility, and fear. J Pediatr Psychol. 2005 Sep;30(6):513-21. doi: 10.1093/jpepsy/jsi076. Epub 2005 Mar 3.
- Background: PubMed 22180760Gonder-Frederick L, Nyer M, Shepard JA, Vajda K, Clarke W. Assessing fear of hypoglycemia in children with Type 1 diabetes and their parents. Diabetes Manag (Lond). 2011;1(6):627-639. doi: 10.2217/DMT.11.60.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physical activity monitor and feedback in people with Diabetes Mellitus, Type 1, run by Sheffield Hallam 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 2 inclusion and 1 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 6 Sep 2018. 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?
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?
Recruitment (time frame: During recruitment (0 months)). The study lists 6 primary outcomes in all. 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 NCT03144869, which also lists 2 linked publications.
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 6 Sep 2018.