Impact on Hypoglycaemia Awareness of Real Time CGM and Intermittent Continuous Glucose Data

NCT ID: NCT03028220

Last Updated: 2019-11-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2017-08-31

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.

Detailed Description

Good glucose control in type 1 diabetes is associated with a reduced risk of diabetes complications and self monitoring of glucose levels is an important component of achieving and maintaining glucose control. Continuous glucose monitoring (CGM) improves overall glucose control in all age groups when used continuously, and reduces the incidence of low blood glucose (hypoglycaemia) in people with good glucose control. Hypoglycaemia is one of the commonest metabolic complications of type 1 diabetes and, if it occurs frequently, people can become less aware of it. This reduced aware of hypoglycaemia has significant risks including seizures, coma and even death, and has an impact on people's ability to drive and function.

The Abbott Libre intermittent glucose monitoring system provides up to 8 hours of retrospective continuous glucose monitoring data to users when the monitor is waved in proximity with the sensor. In contrast to realtime CGM the Libre system sensor is used for 14 days and is non-adjunctive (does not require calibration to capillary blood glucose).

Conditions

Type 1 Diabetes Mellitus With Hypoglycemia; Impaired Awareness of Hypoglycemia; Type1diabetes

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Real time continuous glucose monitoring

Use of Dexcom G5 continuous glucose monitoring

Group Type: ACTIVE_COMPARATOR

Dexcom G5 Continuous Glucose Monitor

Intervention Type: DEVICE

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

Flash glucose monitoring

Use of Abbott FreeStyle Libre flash glucose monitoring

Group Type: ACTIVE_COMPARATOR

Abbott Freestyle Libre

Intervention Type: DEVICE

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

Interventions

Dexcom G5 Continuous Glucose Monitor

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

Intervention Type: DEVICE

Abbott Freestyle Libre

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Imperial College London

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Nick Oliver, FRCP

Role: PRINCIPAL_INVESTIGATOR

Imperial College London

References

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.

Reference Type: DERIVED

PMID: 31375042 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 29230878 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

15HH2875

Identifier Type: -

Identifier Source: org_study_id