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Physical Activity Monitoring Paediatric Type 1 Diabetes

NCT03144869 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2018-09-06

No results posted yet for this study

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. 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.

Conditions

  • Diabetes Mellitus, Type 1

Interventions

BEHAVIORAL

physical activity monitor and feedback

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.

Sponsors & Collaborators

  • Sheffield Children's NHS Foundation Trust

    collaborator OTHER

  • Sheffield Hallam University

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
7 Years
Max Age
11 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-09-01
Primary Completion
2018-08-01
Completion
2018-08-01

Countries

  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03144869 on ClinicalTrials.gov