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

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ClinicalTrials.gov Identifier: NCT03028220
Recruitment Status : Completed
First Posted : January 23, 2017
Results First Posted : April 15, 2019
Last Update Posted : November 13, 2019
Sponsor:
Information provided by (Responsible Party):
Imperial College London

Tracking Information
First Submitted Date  ICMJE December 16, 2016
First Posted Date  ICMJE January 23, 2017
Results First Submitted Date  ICMJE August 10, 2018
Results First Posted Date  ICMJE April 15, 2019
Last Update Posted Date November 13, 2019
Study Start Date  ICMJE January 2016
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: April 12, 2019)
% 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
Original Primary Outcome Measures  ICMJE
 (submitted: January 18, 2017)
% Time Spent in Hypoglycaemia (<3.3mmol/L, 60mg/dL) [ Time Frame: Last two weeks of intervention period ]
Change History Complete list of historical versions of study NCT03028220 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 23, 2019)
  • % 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
  • % 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
  • % 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
  • % 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
  • % 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
  • % 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
  • Hypoglycemia [ Time Frame: 8 weeks ]
    Number of participants with hypoglycemic excursions
  • Severe Hypoglycaemia [ Time Frame: 8 weeks ]
    Number of participants with episodes of severe hypoglycaemia
  • Changes in Glucose Variability Measured [ Time Frame: 8 weeks ]
    Glucose Variability measured by Coefficient of variation (CV), on a decimal scale of 0-1
  • Glucose Variability Measured by MAGE [ Time Frame: 8 weeks ]
    Glucose Variability measured by Mean amplitude of Glycaemic Excursions (MAGE)
  • Glucose Variability Measured by CONGA [ Time Frame: 8 weeks ]
    Glucose Variability measured by Continuous Overlapping Net Glycaemic Action (CONGA)
Original Secondary Outcome Measures  ICMJE
 (submitted: January 18, 2017)
  • % Time Spent in Hypoglycaemia (<2.8mmol/L, 50mg/dL) [ Time Frame: Last two weeks of intervention period ]
  • % Time Spent in Hypoglycaemia (<3.9mmol/L, 70mg/dL) [ Time Frame: Last two weeks of intervention period ]
  • % Time Spent in Euglycaemia (3.9-7.8mmol/L, 70-140mg/dL) [ Time Frame: Last two weeks of intervention period ]
  • % Time Spent in Euglycaemia (3.9-10mmol/L, 70-180mg/dL) [ Time Frame: Last two weeks of intervention period ]
  • % Time Spent in Hyperglycaemia (>10mmol/L, 180mg/dL) [ Time Frame: Last two weeks of intervention period ]
  • % Time Spent in Hyperglycaemia (>15mmol/L, 270mg/dL) [ Time Frame: Last two weeks of intervention period ]
  • Number of hypoglycemic excursions [ Time Frame: 8 weeks ]
  • Incidence of severe hypoglycaemia [ Time Frame: 8 weeks ]
  • Glucose Variability measured by Coefficient of variation (CV) [ Time Frame: 8 weeks ]
  • Glucose Variability measured by Mean amplitude of Glycaemic Excursions (MAGE) [ Time Frame: 8 weeks ]
  • Glucose Variability measured by Continuous Overlapping Net Glycaemic Action (CONGA) [ Time Frame: 8 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Impact on Hypoglycaemia Awareness of Real Time CGM and Intermittent Continuous Glucose Data
Official Title  ICMJE Impact on Hypoglycaemia Awareness of Real Time CGM and Intermittent Continuous
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).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Type 1 Diabetes Mellitus With Hypoglycemia
  • Impaired Awareness of Hypoglycemia
  • Type1diabetes
Intervention  ICMJE
  • Device: Dexcom G5 Continuous Glucose Monitor
    Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values
  • 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
Study Arms  ICMJE
  • Active Comparator: Real time continuous glucose monitoring
    Use of Dexcom G5 continuous glucose monitoring
    Intervention: Device: Dexcom G5 Continuous Glucose Monitor
  • Active Comparator: Flash glucose monitoring
    Use of Abbott FreeStyle Libre flash glucose monitoring
    Intervention: Device: Abbott Freestyle Libre
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: January 18, 2017)
40
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2017
Actual Primary Completion Date February 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03028220
Other Study ID Numbers  ICMJE 15HH2875
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Imperial College London
Study Sponsor  ICMJE Imperial College London
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Nick Oliver, FRCP Imperial College London
PRS Account Imperial College London
Verification Date October 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP