Skip to main content
OpenTrials
Completed

NCT Number: NCT05134025

The SMART A Exercise Study :''The SMART Study''

Despite the promising data emanating from trials investigating the effectiveness of advanced hybrid closed loop (AHCL) insulin delivery systems in managing glycaemia in those with type 1 diabetes (T1D), we currently know little about their efficacy in optimising glycaemia when physical activity is factored into the equation. With the introduction of new AHCL systems that have novel technological features, we are left with important questions of how to optimise their use around physical exercise to not only minimise dysglycaemia, but also encourage individuals with T1D to lead a physically active lifestyle for the associated wider health benefits.

This will be a three-period, randomised, cross-over study with a single-hormone (insulin) AHCL system that compares the efficacy of three insulin management strategies: (i) unannounced exercise and a full dose of meal-time insulin 90-minutes prior to commencement, (ii) a 25% reduced dose of meal-time insulin with exercise announcement 90-minutes prior to commencement and (iii) a 25% dose reduction in meal-time insulin with exercise announcement 45-minutes prior to commencement, in optimising TIR around dynamic physical exercise in adults with T1D.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Steno Diabetes Center Copenhagen

Gentofte Municipality, 2820, Denmark

About this study

Following successful completion of a screening visit, participants will attend the laboratory to complete 3 experimental visits during which they will undertake a 45-minute bout of moderate intensity continuous exercise on a bicycle ergometer at ~60% VȮ2max. Prior to commencing exercise, participants will consume a standardised low-glycaemic index, carbohydrate-based meal (equating to 0.75g.CHO.kg.bm-1) with, or without, a 25% reduction in their meal-time insulin dose as well as with, or without exercise announcement (according to the randomisation). Exercise announcement will increase the individualised target glucose levels to 8.3 mmol.L-1. Venous blood glucose sampling will be taken in 15-minute intervals leading into and after exercise with 5-minute intervals performed during exercise. Samples will be used to retrospectively cross-compare trial day glycaemic responses between visits. Each participant will undertake 1 screening and 3 experimental visits equating to a total of 80 study visits

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • • Type 1 diabetes ≥2 years.
  • HbA1c;
  • 58-63 mmol/mol (maximum 30% of participants) OR
  • ≥ 64 mmol/mol (minimum 70% of participants)
  • Insulin pump treatment ≥12 months
  • CGM or isCGM use ≥6 months
  • Novorapid use ≥4 weeks
  • Carbohydrate counting and use of the insulin pump bolus calculator for most snacks and meals.
  • Carbohydrate intake >80 grams per day (assessed by review of intake recorded in the insulin pump during the 2 weeks prior to the screening visit)

Exclusion criteria

  • • Breast-feeding, pregnancy or planning to become pregnant.
  • Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start.
  • Use of hybrid closed-loop systems
  • Daily use of paracetamol (acetaminophen)
  • Alcohol or drug abuse.
  • Severe cardiac disease or retinopathy contraindicating HbA1c <53 mmol/mol.
  • Other concomitant medical or psychological condition that according to the investigator's assessment makes the person unsuitable for study participation.
  • Lack of compliance with key study procedures at the discretion of the investigator.
  • Unacceptable adverse events at the discretion of the investigator.

Treatment and study plan

Pump settings

Other

Alteration in the pump setting prior to exercise commencement

Primary outcomes

  1. Comparison of TIR in blood glucose values during, and 1-hour after, dynamic physical exercise.

    Time frame: -90 min to +105 min

    To compare the amount of time spent with blood glucose values within the target range during, and 1-hour after, dynamic physical exercise

Other outcomes

  1. Comparison of the occurrence of BG hypoglycaemic events

    Time frame: -90 min to +105 min

    Comparison of the occurrence of blood glucose hypoglycaemic events before during and 1 hour after exercise

  2. Comparison of the depth of BG hypoglycaemic events

    Time frame: -90 min to +105 min

    Comparison of the depth of blood glucose hypoglycaemic events before during and 1 hour after exercise

  3. Comparison of mean BG concentrations

    Time frame: -90 min to +105 min

    Comparison of mean blood glucose concentrations before during and 1 hour after exercise

  4. Comparison of the standard deviation in BG concentrations

    Time frame: -90 min to +105 min

    Comparison of the standard deviation in blood glucose concentrations before during and 1 hour after exercise

  5. Comparison of the coefficient of variation in BG concentrations

    Time frame: -90 min to +105min

    Comparison of the coefficient of variation in blood glucose concentrations before during and 1 hour after exercise

  6. Comparison of the minimum BG concentration

    Time frame: -90 min to +105min

    Comparison of the minimum blood glucose concentration before during and 1 hour after exercise

  7. Comparison of the maximum BG concentration

    Time frame: -90 min to +105min

    Comparison of the maximum blood glucose concentration before during and 1 hour after exercise

  8. ΔBGexercise: Changes in BG concentrations during exercise

    Time frame: 0 min to +45 min

    ΔBGexercise: Changes in blood glucose concentrations during exercise

  9. ΔiGexercise: Changes in iG concentrations during exercise

    Time frame: 0 min to +45 min

    ΔiGexercise: Changes in interstitial glucose concentrations during exercise

  10. ΔBGfeeding: Change in BG concentrations after feeding

    Time frame: -90 min to 0min

    ΔBGfeeding: Change in blood glucose concentrations after feeding

  11. ΔiGfeeding: Change in iG concentrations after feeding

    Time frame: -90 min to 0min

    ΔiGfeeding: Change in interstitial glucose concentrations after feeding

  12. Comparison of TBR level 2 in iG values

    Time frame: -90 min to +105 min

    Comparison of TBR level 2 in interstitial glucose values before during and 1 hour after exercise

  13. Comparison of TBR level 1 in iG values

    Time frame: -90 min to +105 min

    Comparison of TBR level 1 in interstitial glucose values before during and 1 hour after exercise

  14. Comparison of TAR level 1 in iG values

    Time frame: -90 min to +105 min

    Comparison of the amount of time spent with interstitial glucose values above the target range level 1 before during and 1 hour after exercise

  15. Comparison of TAR level 2 in iG values

    Time frame: -90 min to +105 min

    Comparison of the amount of time spent with interstitial glucose values above the target range level 2 before during and 1 hour after exercise

  16. Comparison of mean iG concentrations

    Time frame: -90 min to +105 min

    Comparison of mean interstitial glucose concentrations before during and 1 hour after exercise

  17. Comparison of the standard deviation in iG concentrations

    Time frame: -90 min to +105 min

    Comparison of the standard deviation in interstitial glucose concentrations before during and 1 hour after exercise

  18. Comparison of the coefficient of variation in iG concentrations

    Time frame: -90 min to +105 min

    Comparison of the coefficient of variation in interstitial glucose concentrations before during and 1 hour after exercise

  19. Comparison of the minimum iG concentration

    Time frame: -90 min to +105 min

    Comparison of the minimum interstitial glucose concentration before during and 1 hour after exercise

  20. Comparison of the maximum iG concentration

    Time frame: -90 min to +105 min

    Comparison of the maximum interstitial glucose concentration before during and 1 hour after exercise

Sponsors and collaborators

Lead sponsor

Steno Diabetes Center Copenhagen

Other

Collaborators

  • Swansea University

Registry information

Official study title

Optimising Glycaemia Around Dynamic Physical Exercise With Advanced Hybrid-closed-loop Therapy Use in Type 1 Diabetes: ''The SMART Study''

Acronym: SMART

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Nov 24, 2021
Registry last updated
Nov 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.