Clinical trial NCT03028220: Impact on Hypoglycaemia Awareness of Real Time CGM and Intermittent Continuous Glucose Data
Official title: Impact on Hypoglycaemia Awareness of Real Time CGM and Intermittent Continuous
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus With Hypoglycemia
Impaired Awareness of Hypoglycemia
Type1diabetes
Keywords: Type 1 Diabetes
Hypoglycemia
Lead sponsor: Imperial College London
Sponsor class: OTHER
First posted: 2017-01-23
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: % Time Spent in Hypoglycaemia (<3.3mmol/L, 60mg/dL)
timeFrame: 10 weeks
Secondary outcomes:
measure: % Time Spent in Hypoglycaemia (<2.8mmol/L, 50mg/dL)
timeFrame: 10 weeks
measure: % Time Spent in Hypoglycaemia (<3.9mmol/L, 70mg/dL)
timeFrame: 10 weeks
measure: % Time Spent in Euglycaemia (3.9-7.8mmol/L, 70-140mg/dL)
timeFrame: 10 weeks
measure: % Time Spent in Euglycaemia (3.9-10mmol/L, 70-180mg/dL)
timeFrame: 10 weeks
measure: % Time Spent in Hyperglycaemia (>10mmol/L, 180mg/dL)
timeFrame: 10 weeks
measure: % Time Spent in Hyperglycaemia (>15mmol/L, 270mg/dL)
timeFrame: 10 weeks
measure: Hypoglycemia
timeFrame: 8 weeks
measure: Severe Hypoglycaemia
timeFrame: 8 weeks
measure: Changes in Glucose Variability Measured
timeFrame: 8 weeks
measure: Glucose Variability Measured by MAGE
timeFrame: 8 weeks
measure: Glucose Variability Measured by CONGA
timeFrame: 8 weeks
Other outcomes:
Locations:
Study officials:
affiliation: Imperial College London
name: Nick Oliver, FRCP
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.