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

NCT04142944 | Completed DMC FDA Device

• 1 other identifier: 19HH5053
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Type1diabetes

Keywords

Type1 diabetes; device with predictive hypo alert

Outcome Measures

Primary Outcomes (1)

• Time in hypo glycaemia

  time (minutes and %) spent in hypoglycaemia (\<3.0mmol/L, 54mg/dL) during and for 12 and 24 hours after exercise

  24 hours

Study Arms (2)

Dexcom G6 with predictive hypo alert

EXPERIMENTAL

Device: Dexcom G6 with alert

Dexcom G6 without predictive hypo alert

ACTIVE COMPARATOR

Device: Dexcom G6 without alert

Interventions

Dexcom G6 with alert DEVICE

Dexcom G6 CGM device with the predictive hypoglycaemia alert function

Dexcom G6 with predictive hypo alert

Dexcom G6 without alert DEVICE

Dexcom G6 CGM device without the predictive hypoglycaemia alert function

Dexcom G6 without predictive hypo alert

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Imperial College London: lead

Study Sites (1)

Imperial College London

London, United Kingdom

Location

Study Officials

• Neil Hill

  Imperial College London

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Observational, within-subject, crossover study

Study Record Dates

• First Submitted: October 25, 2019
• First Posted: October 29, 2019
• Study Start: December 11, 2019
• Primary Completion: July 27, 2021
• Study Completion: July 27, 2021
• Last Updated: November 12, 2021

Record last verified: 2021-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)