Continuous Glucose Monitoring and Hypoglycemia Unawareness in Type 1 Diabetes

NCT ID: NCT03605979

Last Updated: 2018-07-30

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 11 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-07-01
• Study Completion Date: 2013-06-01

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 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.

Conditions

Type 1 Diabetes

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

diabetes group

Patient with hypoglycemia unawareness

No interventions assigned to this group

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CHU de Reims

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Damien JOLLY

Reims, , France

Countries

France

References

Zalzali M, Houdelet-Guerinot V, Socquard E, Thierry A, Delemer B, Lukas-Croisier C. Continuous glucose monitoring and hypoglycemia unawareness in type 1 diabetes: a pilot study. Minerva Endocrinol. 2017 Sep;42(3):195-202. doi: 10.23736/S0391-1977.16.02326-9. Epub 2015 Jul 10.

Reference Type: BACKGROUND

PMID: 26159765 (View on PubMed)

Other Identifiers

2017Ao003

Identifier Type: -

Identifier Source: org_study_id