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Impact on Hypoglycaemia Awareness of Real Time CGM and Intermittent Continuous Glucose Data (IHART-CGM)

Imperial College London logo

Imperial College London

Status

Completed

Conditions

Impaired Awareness of Hypoglycemia
Type 1 Diabetes Mellitus With Hypoglycemia
Type1diabetes

Treatments

Device: Dexcom G5 Continuous Glucose Monitor
Device: Abbott Freestyle Libre

Study type

Interventional

Funder types

Other

Identifiers

NCT03028220
15HH2875

Details and patient eligibility

About

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.

Full 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).

Enrollment

40 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

40 participants in 2 patient groups

Real time continuous glucose monitoring
Active Comparator group
Description:
Use of Dexcom G5 continuous glucose monitoring
Treatment:
Device: Dexcom G5 Continuous Glucose Monitor
Flash glucose monitoring
Active Comparator group
Description:
Use of Abbott FreeStyle Libre flash glucose monitoring
Treatment:
Device: Abbott Freestyle Libre

Trial documents
1

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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