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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

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Mellitus With Hypoglycemia Impaired Awareness of Hypoglycemia Type1diabetes Device: Dexcom G5 Continuous Glucose Monitor Device: Abbott Freestyle Libre Not Applicable

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).


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Impact on Hypoglycaemia Awareness of Real Time CGM and Intermittent Continuous
Study Start Date : January 2016
Actual Primary Completion Date : February 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Hypoglycemia
Drug Information available for: Dextrose

Arm Intervention/treatment
Active Comparator: Real time continuous glucose monitoring
Use of Dexcom G5 continuous glucose monitoring
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

Active Comparator: Flash glucose monitoring
Use of Abbott FreeStyle Libre flash glucose monitoring
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




Primary Outcome Measures :
  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 Outcome Measures :
  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)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03028220


Sponsors and Collaborators
Imperial College London
Investigators
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Principal Investigator: Nick Oliver, FRCP Imperial College London
  Study Documents (Full-Text)

Documents provided by Imperial College London:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Imperial College London
ClinicalTrials.gov Identifier: NCT03028220     History of Changes
Other Study ID Numbers: 15HH2875
First Posted: January 23, 2017    Key Record Dates
Results First Posted: April 15, 2019
Last Update Posted: November 13, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Imperial College London:
Type 1 Diabetes
Hypoglycemia
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Hypoglycemia
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases