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Completed

NCT Number: NCT03028220

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

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.

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Key information

Conditions

Type 1 Diabetes Mellitus With Hypoglycemia Autoimmune Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Hypoglycemia Immune System Diseases Impaired Awareness of Hypoglycemia Metabolic Diseases Nutritional and Metabolic Diseases Type1diabetes

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dexcom G5 Continuous Glucose Monitor

Device

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

Abbott Freestyle Libre

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

Primary outcomes

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

    Time frame: 10 weeks

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

Secondary outcomes

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

    Time frame: 10 weeks

    Percentage time spent in hypoglycaemia (<2.8mmol/L, 50mg/dL) change from baseline

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

    Time frame: 10 weeks

    Percentage time spent in hypoglycaemia (<3.9mmol/L, 70mg/dL) change in baseline to endpint

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

    Time frame: 10 weeks

    Percentage time spent in euglycaemia (3.9-7.8mmol/L, 70-140mg/dL) change in baseline to endpoint

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

    Time frame: 10 weeks

    Percentage time spent in euglycaemia (3.9-10mmol/L, 70-180mg/dL) change in baseline to endpoint

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

    Time frame: 10 weeks

    Percentage time spent in hyperglycaemia (>10mmol/L, 180mg/dL) change in baseline to endpoint

  6. % Time Spent in Hyperglycaemia (>15mmol/L, 270mg/dL)

    Time frame: 10 weeks

    % time spent in hyperglycaemia (>15mmol/L, 270mg/dL) change in baseline to endpoint

  7. Hypoglycemia

    Time frame: 8 weeks

    Number of participants with hypoglycemic excursions

  8. Severe Hypoglycaemia

    Time frame: 8 weeks

    Number of participants with episodes of severe hypoglycaemia

  9. Changes in Glucose Variability Measured

    Time frame: 8 weeks

    Glucose Variability measured by Coefficient of variation (CV), on a decimal scale of 0-1

  10. Glucose Variability Measured by MAGE

    Time frame: 8 weeks

    Glucose Variability measured by Mean amplitude of Glycaemic Excursions (MAGE)

  11. Glucose Variability Measured by CONGA

    Time frame: 8 weeks

    Glucose Variability measured by Continuous Overlapping Net Glycaemic Action (CONGA)

Sponsors and collaborators

Lead sponsor

Imperial College London

Other

Registry information

Official study title

Impact on Hypoglycaemia Awareness of Real Time CGM and Intermittent Continuous

Acronym: IHART-CGM

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jan 23, 2017
Registry last updated
Nov 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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