Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 12 of 873 for:    hypoglycemia | "Diabetes Mellitus, Insulin-Dependent"

Continuous Glucose Monitoring and Hypoglycemia Unawareness in Type 1 Diabetes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03605979
Recruitment Status : Completed
First Posted : July 30, 2018
Last Update Posted : July 30, 2018
Sponsor:
Information provided by (Responsible Party):
CHU de Reims

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.

Condition or disease
Type 1 Diabetes

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 corrected. Hypoglycemic manifestations were divided into adrenergic (shakiness, anxiety, palpitations, sweating, hunger, nausea, headache, coldness and pallor) and neuroglycopenic effects (impaired judgment, moodiness, paresthesia, emotional lability, confusion, ataxia, double vision, amnesia, seizures and lethargy). The confrontation of hypoglycemia detected by the blinded CG M and self-reported hypoglycemia validated the diagnosis of hypoglycemia unawareness.

Patients used the Paradigm® Veo™ pump and glucose sensors (trademark : Enlite®) with an hypoglycemia alarm set at sensor glucose value of 70 mg/dL while the LG S option was set to suspend insulin delivery at a sensor glucose value of 50 mg/dL or less. These thresholds allowed an active correction of hypoglycemia by the patient between 50 and 70 mg/dL. Patients were educated to use the system and to treat and manage hypoglycemia. Pump data were uploaded using the trademark Medtronic CareLink™ Management Software for Diabetes during visits at 10 days (D10), 2 months (M2) and 3 months (M3). Hypoglycemia awareness was assessed by an initial quiz that was repeated at M3 and 6 months (M6). A blinded CGM iPro ™ 2 was also realized at M3 to validate the modifications after sensor-augmented insulin-pump therapy.


Layout table for study information
Study Type : Observational
Actual Enrollment : 11 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Continuous Glucose Monitoring and Hypoglycemia Unawareness in Type 1 Diabetes: a Pilot Study
Actual Study Start Date : July 1, 2012
Actual Primary Completion Date : February 1, 2013
Actual Study Completion Date : June 1, 2013

Resource links provided by the National Library of Medicine


Group/Cohort
diabetes group
Patient with hypoglycemia unawareness



Primary Outcome Measures :
  1. Glycemia measured by continuous glucose monitoring (CGM) and pump [ Time Frame: Day 0 ]
  2. Glycemia measured by continuous glucose monitoring (CGM) and pump [ Time Frame: day 10 ]
  3. Glycemia measured by continuous glucose monitoring (CGM) and pump [ Time Frame: Month 2 ]
  4. Glycemia measured by continuous glucose monitoring (CGM) and pump [ Time Frame: Month 3 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient with hypoglycemia unawareness
Criteria

Inclusion Criteria:

  • >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

Exclusion Criteria:

  • > 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

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): NCT03605979


Locations
Layout table for location information
France
Damien JOLLY
Reims, France
Sponsors and Collaborators
CHU de Reims

Publications:
Layout table for additonal information
Responsible Party: CHU de Reims
ClinicalTrials.gov Identifier: NCT03605979     History of Changes
Other Study ID Numbers: 2017Ao003
First Posted: July 30, 2018    Key Record Dates
Last Update Posted: July 30, 2018
Last Verified: July 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by CHU de Reims:
type 1 diabetes
hypoglycemia unawareness
Insulin pump
Continuous glucose monitoring systems
Low glucose suspend

Additional relevant MeSH terms:
Layout table for MeSH terms
Diabetes Mellitus, Type 1
Hypoglycemia
Diabetes Mellitus
Unconsciousness
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases
Consciousness Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms