Assessment of the Impact of Real-Time Continuous Glucose Monitoring on People Presenting With Severe Hypoglycaemia

NCT03748433 | Terminated Results

• 1 other identifier: 18HH4609
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the impact of real-time continuous glucose monitoring on the frequency, duration, awareness and severity of hypoglycaemia in people with type 1 diabetes and a recent history of severe hypoglycaemia, compared to usual care.

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia Unawareness; Hypoglycemia

Keywords

Real time continuous glucose monitoring; continuous subcutaneous insulin infusion; self monitoring blood glucose; sensor augmented pump; severe hypoglycaemia; hypounaware

Outcome Measures

Primary Outcomes (1)

• Time Spent in Hypoglycaemia

  Percentage time spent in hypoglycaemia (\<3.0mmol/L, 55mg/dL)

  12 weeks

Study Arms (3)

Continuous Glucose Monitoring (CGM)

EXPERIMENTAL

The RT CGM group will receive a Dexcom G6 transmitter and sensors, as well as a structured education refresher focusing on hypoglycaemia avoidance, recognition, and management.

Device: Dexcom G6 CGM

Self Monitoring Blood Glucose (SMBG)

NO INTERVENTION

The SMBG group will additionally undergo blinded CGM at weeks 1 and 2, weeks 4 to 6 and weeks 9 to 12 using the Dexcom G6 system. Participants in this group will be shown how to insert the Dexcom G6 at the first clinic visit and sensors provided so they can do this at home.

Continuous Subcutaneous Insulin Infusion (CSII)

EXPERIMENTAL

All participants will be re-consented with the choice to continue using RT-CGM for a further 16 weeks or be re-randomised to either receive the Tandem t:slim X2 insulin pump or RT-CGM. Participants randomised to the Tandem t:slim X2 group will be proficiently trained to safely use the Tandem t:slim X2 insulin pump. All participants (Tandem t:slim X2 and RT-CGM) will be provided with Dexcom G6 real time CGM transmitters and sensors for the 16-week second extension phase.

Device: Dexcom G6 CGM; Device: Tandem t:slim X2 Insulin Pump

Interventions

Dexcom G6 CGM DEVICE

Commercially available Dexcom G6 Continuous Glucose Monitoring

Continuous Glucose Monitoring (CGM); Continuous Subcutaneous Insulin Infusion (CSII)

Tandem t:slim X2 Insulin Pump DEVICE

sensor augmented insulin pump with predictive low glucose suspend

Continuous Subcutaneous Insulin Infusion (CSII)

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
• Severe hypoglycaemia requiring ambulance call-out or emergency department attendance within 2 weeks
• Type 1 diabetes confirmed on the basis of clinical features
• Type 1 diabetes for greater than 3 years

You may not qualify if:

• Use of CGM within the last 6 months (except short periods of diagnostic blinded use under clinic supervision). Prior use of Abbott FreeStyle Libre Device is permitted.
• Use of pre-mixed insulin
• No access to smartphone or computer
• Pregnant or planning pregnancy
• Breastfeeding
• 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 Investigators
• 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
• London Ambulance Service: collaborator

Study Sites (1)

Imperial College Clinical Research Facility

London, United Kingdom

Location

Related Publications (1)

• Avari P, Ramli R, Reddy M, Oliver N, Fothergill R. Rationale and protocol for the Assessment of Impact of Real-time Continuous Glucose Monitoring on people presenting with severe Hypoglycaemia (AIR-CGM) study. BMC Endocr Disord. 2019 Oct 26;19(1):110. doi: 10.1186/s12902-019-0439-3.

  PMID: 31655586 DERIVED

Related Links

• NICE Guidelines

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Limitations and Caveats

The study was terminated early after the interim analysis. It was deemed unethical to offer SMBG to this high risk population.

Results Point of Contact

• Title: Professor Nick Oliver
• Organization: Imperial College London

nick.oliver@imperial.ac.uk

+44 (0)20 7594 1796

Study Officials

• Nick Oliver

  Imperial College London

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

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

Model Details: Randomised open-label parallel group study

Study Record Dates

• First Submitted: November 7, 2018
• First Posted: November 20, 2018
• Study Start: January 3, 2019
• Primary Completion: September 9, 2021
• Study Completion: September 9, 2021
• Last Updated: March 22, 2024
• Results First Posted: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)