Continuous Glucose Monitoring and Hypoglycemia Unawareness in Type 1 Diabetes
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|ClinicalTrials.gov Identifier: NCT03605979|
Recruitment Status : Completed
First Posted : July 30, 2018
Last Update Posted : July 30, 2018
|Condition or disease|
|Type 1 Diabetes|
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.
|Study Type :||Observational|
|Actual Enrollment :||11 participants|
|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|
Patient with hypoglycemia unawareness
- Glycemia measured by continuous glucose monitoring (CGM) and pump [ Time Frame: Day 0 ]
- Glycemia measured by continuous glucose monitoring (CGM) and pump [ Time Frame: day 10 ]
- Glycemia measured by continuous glucose monitoring (CGM) and pump [ Time Frame: Month 2 ]
- Glycemia measured by continuous glucose monitoring (CGM) and pump [ Time Frame: Month 3 ]
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