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The Impact of a Predictive Hypoglycaemia Alert Function in Physical Activity for People With T1DM (PACE)

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ClinicalTrials.gov Identifier: NCT04142944
Recruitment Status : Completed
First Posted : October 29, 2019
Last Update Posted : November 12, 2021
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Brief Summary:

Observational, within-subject, crossover study

To assess the impact of Dexcom G6 RT-CGM with a predictive hypoglycaemia alert function on the frequency, duration and severity of hypoglycaemia occurring before, during and after regular physical activity in people with type 1 diabetes

At Imperial College Healthcare NHS Trust have established the multi-disciplinary Imperial Physical Activity and Diabetes (IPAD) clinic to empower, educate and enable people with diabetes to manage their blood glucose when they undertake physical activity. The investigator utilise the skills and expertise of a consultant diabetologist, a diabetes dietitian, a consultant in sports & exercise medicine, and a diabetes specialist nurse with expertise in diabetes technology. The investigator have access to diagnostic & therapeutic radiology, physiotherapy and psychology services.


Condition or disease Intervention/treatment Phase
Type1diabetes Device: Dexcom G6 with alert Device: Dexcom G6 without alert Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Observational, within-subject, crossover study
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: The Impact of Continuous Glucose Monitoring With a Predictive Hypoglycaemia Alert Function on Hypoglycaemia in Physical Activity for People With Type 1 Diabetes
Actual Study Start Date : December 11, 2019
Actual Primary Completion Date : July 27, 2021
Actual Study Completion Date : July 27, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Dexcom G6 with predictive hypo alert Device: Dexcom G6 with alert
Dexcom G6 CGM device with the predictive hypoglycaemia alert function

Active Comparator: Dexcom G6 without predictive hypo alert Device: Dexcom G6 without alert
Dexcom G6 CGM device without the predictive hypoglycaemia alert function




Primary Outcome Measures :
  1. Time in hypo glycaemia [ Time Frame: 24 hours ]
    time (minutes and %) spent in hypoglycaemia (<3.0mmol/L, 54mg/dL) during and for 12 and 24 hours after exercise



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

INCLUSION CRITERIA

  • Adults over 18 years of age
  • Type 1 diabetes (confirmed on the basis of clinical features)
  • On a multiple dose insulin injection regimen or insulin pump for > 6 months Has received structured diabetes self-management education (either group or 1:1)
  • Undertaking regular exercise (meeting Chief Medical Officer recommended exercise guidelines) and able to comply with study protocol
  • Owns and uses a smartphone

EXCLUSION CRITERIA

  • Pregnant or planning pregnancy
  • Breastfeeding
  • Enrolled in other clinical trials
  • Have active malignancy or under investigation for malignancy
  • Severe visual impairment
  • Reduced manual dexterity
  • Unable to participate due to other factors, as assessed by the Chief Investigator

WITHDRAWAL CRITERIA

Participants will be withdrawn if their ability to give informed consent is impaired. Participants will also be withdrawn, at the chief investigators discretion, if glucose control is negatively impacted by the use of either intervention.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04142944


Locations
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United Kingdom
Imperial College London
London, United Kingdom
Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Neil Hill Imperial College London
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT04142944    
Other Study ID Numbers: 19HH5053
First Posted: October 29, 2019    Key Record Dates
Last Update Posted: November 12, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Imperial College London:
Type1 diabetes
device with predictive hypo alert
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Hypoglycemia
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases