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

Primary Purpose

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

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Dexcom G5 Continuous Glucose Monitor
Abbott Freestyle Libre
Sponsored by
Imperial College London
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus With Hypoglycemia focused on measuring Type 1 Diabetes, Hypoglycemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Active Comparator

    Arm Label

    Real time continuous glucose monitoring

    Flash glucose monitoring

    Arm Description

    Use of Dexcom G5 continuous glucose monitoring

    Use of Abbott FreeStyle Libre flash glucose monitoring

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    % Time Spent in Hypoglycaemia (<2.8mmol/L, 50mg/dL)
    Percentage time spent in hypoglycaemia (<2.8mmol/L, 50mg/dL) change from baseline
    % Time Spent in Hypoglycaemia (<3.9mmol/L, 70mg/dL)
    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)
    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)
    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)
    Percentage time spent in hyperglycaemia (>10mmol/L, 180mg/dL) change in baseline to endpoint
    % Time Spent in Hyperglycaemia (>15mmol/L, 270mg/dL)
    % time spent in hyperglycaemia (>15mmol/L, 270mg/dL) change in baseline to endpoint
    Hypoglycemia
    Number of participants with hypoglycemic excursions
    Severe Hypoglycaemia
    Number of participants with episodes of severe hypoglycaemia
    Changes in Glucose Variability Measured
    Glucose Variability measured by Coefficient of variation (CV), on a decimal scale of 0-1
    Glucose Variability Measured by MAGE
    Glucose Variability measured by Mean amplitude of Glycaemic Excursions (MAGE)
    Glucose Variability Measured by CONGA
    Glucose Variability measured by Continuous Overlapping Net Glycaemic Action (CONGA)

    Full Information

    First Posted
    December 16, 2016
    Last Updated
    October 23, 2019
    Sponsor
    Imperial College London
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03028220
    Brief Title
    Impact on Hypoglycaemia Awareness of Real Time CGM and Intermittent Continuous Glucose Data
    Acronym
    IHART-CGM
    Official Title
    Impact on Hypoglycaemia Awareness of Real Time CGM and Intermittent Continuous
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2019
    Overall Recruitment Status
    Completed
    Study Start Date
    January 2016 (undefined)
    Primary Completion Date
    February 2017 (Actual)
    Study Completion Date
    August 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Imperial College London

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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).

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 1 Diabetes Mellitus With Hypoglycemia, Impaired Awareness of Hypoglycemia, Type1diabetes
    Keywords
    Type 1 Diabetes, Hypoglycemia

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    40 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Real time continuous glucose monitoring
    Arm Type
    Active Comparator
    Arm Description
    Use of Dexcom G5 continuous glucose monitoring
    Arm Title
    Flash glucose monitoring
    Arm Type
    Active Comparator
    Arm Description
    Use of Abbott FreeStyle Libre flash glucose monitoring
    Intervention Type
    Device
    Intervention Name(s)
    Dexcom G5 Continuous Glucose Monitor
    Intervention Description
    Real time continuous glucose sensor connected to monitor providing data and alarms and alerts for glucose trends and values
    Intervention Type
    Device
    Intervention Name(s)
    Abbott Freestyle Libre
    Intervention Description
    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 Outcome Measure Information:
    Title
    % Time Spent in Hypoglycaemia (<3.3mmol/L, 60mg/dL)
    Description
    Percentage time spent in hypoglycaemia (<3.3mmol/L, 60mg/dL) change from baseline
    Time Frame
    10 weeks
    Secondary Outcome Measure Information:
    Title
    % Time Spent in Hypoglycaemia (<2.8mmol/L, 50mg/dL)
    Description
    Percentage time spent in hypoglycaemia (<2.8mmol/L, 50mg/dL) change from baseline
    Time Frame
    10 weeks
    Title
    % Time Spent in Hypoglycaemia (<3.9mmol/L, 70mg/dL)
    Description
    Percentage time spent in hypoglycaemia (<3.9mmol/L, 70mg/dL) change in baseline to endpint
    Time Frame
    10 weeks
    Title
    % Time Spent in Euglycaemia (3.9-7.8mmol/L, 70-140mg/dL)
    Description
    Percentage time spent in euglycaemia (3.9-7.8mmol/L, 70-140mg/dL) change in baseline to endpoint
    Time Frame
    10 weeks
    Title
    % Time Spent in Euglycaemia (3.9-10mmol/L, 70-180mg/dL)
    Description
    Percentage time spent in euglycaemia (3.9-10mmol/L, 70-180mg/dL) change in baseline to endpoint
    Time Frame
    10 weeks
    Title
    % Time Spent in Hyperglycaemia (>10mmol/L, 180mg/dL)
    Description
    Percentage time spent in hyperglycaemia (>10mmol/L, 180mg/dL) change in baseline to endpoint
    Time Frame
    10 weeks
    Title
    % Time Spent in Hyperglycaemia (>15mmol/L, 270mg/dL)
    Description
    % time spent in hyperglycaemia (>15mmol/L, 270mg/dL) change in baseline to endpoint
    Time Frame
    10 weeks
    Title
    Hypoglycemia
    Description
    Number of participants with hypoglycemic excursions
    Time Frame
    8 weeks
    Title
    Severe Hypoglycaemia
    Description
    Number of participants with episodes of severe hypoglycaemia
    Time Frame
    8 weeks
    Title
    Changes in Glucose Variability Measured
    Description
    Glucose Variability measured by Coefficient of variation (CV), on a decimal scale of 0-1
    Time Frame
    8 weeks
    Title
    Glucose Variability Measured by MAGE
    Description
    Glucose Variability measured by Mean amplitude of Glycaemic Excursions (MAGE)
    Time Frame
    8 weeks
    Title
    Glucose Variability Measured by CONGA
    Description
    Glucose Variability measured by Continuous Overlapping Net Glycaemic Action (CONGA)
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nick Oliver, FRCP
    Organizational Affiliation
    Imperial College London
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    Citations:
    PubMed Identifier
    31375042
    Citation
    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.
    Results Reference
    derived
    PubMed Identifier
    29230878
    Citation
    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.
    Results Reference
    derived

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

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