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Continuous Glucose Monitoring and Hypoglycemia Unawareness in Type 1 Diabetes 11

Completed
Clinical Trial NCT03605979 was an observational study for Type 1 Diabetes that is now completed. The study started on 1 July 2012, with plans to enroll 11 participants. Led by CHU de Reims, the expected completion date was 1 June 2013. The latest data from ClinicalTrials.gov was last updated on 30 July 2018.
Brief Summary
Looking for strict normoglycemia in type 1 diabetes increases the risk of hypoglycemia, exposing to hypoglycemia unawareness. It has been shown that the early correction of hypoglycemia can help recovering the perception of hypoglycemia. The purpose of this prospective study was to assess the value of sensor-augmented insulin-pump therapy to treat hypoglycemia unawareness.
Detailed Description
To confirm hypoglycemia unawareness, patients answered a questionnaire based on the items explored by the model of Clarke 19 about hypoglycemia and hypoglycemia awareness. The eligibility of patients was confirmed by a blinded CG M recording using the trademark iPro ™ 2 sensor for 6 days. During this period the patient reported on a logbook the perception of their hypoglycemia, symptoms and how any hypoglycemia was c...Show More
Official Title

Continuous Glucose Monitoring and Hypoglycemia Unawareness in Type 1 Diabetes: a Pilot Study

Conditions
Type 1 Diabetes
Publications
Scientific articles and research papers published about this clinical trial:
Other Study IDs
  • 2017Ao003
NCT ID Number
NCT03605979
Start Date (Actual)
2012-07-01
Last Update Posted
2018-07-30
Completion Date (Estimated)
2013-06-01
Enrollment (Estimated)
11
Study Type
Observational
Status
Completed
Keywords
type 1 diabetes
hypoglycemia unawareness
Insulin pump
Continuous glucose monitoring systems
Low glucose suspend
Arms / Interventions
Participant Group/ArmIntervention/Treatment
diabetes group
Patient with hypoglycemia unawareness
N/A
Primary Outcome Measures
Outcome MeasureMeasure DescriptionTime Frame
Glycemia measured by continuous glucose monitoring (CGM) and pump
Day 0
Glycemia measured by continuous glucose monitoring (CGM) and pump
day 10
Glycemia measured by continuous glucose monitoring (CGM) and pump
Month 2
Glycemia measured by continuous glucose monitoring (CGM) and pump
Month 3
Eligibility Criteria

Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
  • >18 years
  • type 1 diabetes
  • had been treated with insulin pump for more than three months
  • had hypoglycemia unawareness with a hypoglycemia perception threshold below 60 mg/dL and/or had had at least one severe hypoglycemia event in the previous year

  • > 18 years
  • any serious disease that could interfere with the study
  • pregnancy,
  • incompatibility with monitoring,
  • irregular management of diabetes,
  • hearing loss and low vision,
  • preventing them from using the devices
CHU de Reims logoCHU de Reims
No contact data.
1 Study Locations in 1 Countries
Damien JOLLY, Reims, France