NCT03028220

Brief Summary

This clinical study proposes to assess the impact of Libre on frequency, duration and severity of hypoglycaemia, compared with the Dexcom G5 realtime CGM and will focus on people with impaired awareness of hypoglycaemia.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2016

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

December 16, 2016

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 23, 2017

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2017

Completed
1.7 years until next milestone

Results Posted

Study results publicly available

April 16, 2019

Completed
Last Updated

November 13, 2019

Status Verified

October 1, 2019

Enrollment Period

1.1 years

First QC Date

December 16, 2016

Results QC Date

August 10, 2018

Last Update Submit

October 23, 2019

Conditions

Type 1 Diabetes Mellitus With HypoglycemiaImpaired Awareness of HypoglycemiaType1diabetes

Keywords

Type 1 DiabetesHypoglycemia

Outcome Measures

Primary Outcomes (1)

  • % Time Spent in Hypoglycaemia (<3.3mmol/L, 60mg/dL)

    Percentage time spent in hypoglycaemia (\<3.3mmol/L, 60mg/dL) change from baseline

    10 weeks

Secondary Outcomes (11)

  • % Time Spent in Hypoglycaemia (<2.8mmol/L, 50mg/dL)

    10 weeks

  • % Time Spent in Hypoglycaemia (<3.9mmol/L, 70mg/dL)

    10 weeks

  • % Time Spent in Euglycaemia (3.9-7.8mmol/L, 70-140mg/dL)

    10 weeks

  • % Time Spent in Euglycaemia (3.9-10mmol/L, 70-180mg/dL)

    10 weeks

  • % Time Spent in Hyperglycaemia (>10mmol/L, 180mg/dL)

    10 weeks

  • +6 more secondary outcomes

Study Arms (2)

Real time continuous glucose monitoring

ACTIVE COMPARATOR

Use of Dexcom G5 continuous glucose monitoring

Device: Dexcom G5 Continuous Glucose Monitor

Flash glucose monitoring

ACTIVE COMPARATOR

Use of Abbott FreeStyle Libre flash glucose monitoring

Device: Abbott Freestyle Libre

Interventions

Dexcom G5 Continuous Glucose MonitorDEVICE

Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values

Real time continuous glucose monitoring
Abbott Freestyle LibreDEVICE

Continuous glucose recording device which reports glucose concentration and trend on demand, along with a retrospective review of the last 8 hours glucose data

Flash glucose monitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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 and a fasting c-peptide \<200 pmol/L
  • Severe hypoglycaemic event in the last 12 months requiring third party assistance OR a Gold Score ≥ 4
  • Type 1 diabetes for greater than 3 years
  • On an intensified multiple dose insulin injection regimen for \> 6 months (MDI)
  • Previous type 1 diabetes structured education (either group or 1:1)

You may not qualify if:

  • Use of CGM or Libre device within the last 6 months (except short periods of diagnostic blinded use under clinic supervision)
  • Use of regular paracetamol
  • Pregnant or planning pregnancy
  • Breastfeeding
  • Enrolled in other clinical trials, except at the discretion of the chief investigator
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Avari P, Moscardo V, Jugnee N, Oliver N, Reddy M. Glycemic Variability and Hypoglycemic Excursions With Continuous Glucose Monitoring Compared to Intermittently Scanned Continuous Glucose Monitoring in Adults With Highest Risk Type 1 Diabetes. J Diabetes Sci Technol. 2020 May;14(3):567-574. doi: 10.1177/1932296819867688. Epub 2019 Aug 2.

    PMID: 31375042DERIVED

  • Reddy M, Jugnee N, El Laboudi A, Spanudakis E, Anantharaja S, Oliver N. A randomized controlled pilot study of continuous glucose monitoring and flash glucose monitoring in people with Type 1 diabetes and impaired awareness of hypoglycaemia. Diabet Med. 2018 Apr;35(4):483-490. doi: 10.1111/dme.13561. Epub 2017 Dec 29.

    PMID: 29230878DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Results Point of Contact

Title
Prof Nick Oliver
Organization
Imperial College London
nick.oliver@imperial.ac.uk
02075942460

Study Officials

  • Nick Oliver, FRCP

    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

Study Record Dates

First Submitted

December 16, 2016

First Posted

January 23, 2017

Study Start

January 1, 2016

Primary Completion

February 1, 2017

Study Completion

August 1, 2017

Last Updated

November 13, 2019

Results First Posted

April 16, 2019

Record last verified: 2019-10

Data Sharing

IPD Sharing
Will not share