Continuous Glucose Monitoring and Hypoglycemia Unawareness in Type 1 Diabetes

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

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.

Study Overview

• Status: Completed
• Conditions: 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.

• Study Type: Observational
• Enrollment (Actual): 11

Contacts and Locations

Study Locations

• France
  • Reims, France
    • Damien JOLLY

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patient with hypoglycemia unawareness

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
diabetes group; Patient with hypoglycemia unawareness

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time 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

Collaborators and Investigators

• Sponsor: CHU de Reims

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2012
• Primary Completion (Actual): February 1, 2013
• Study Completion (Actual): June 1, 2013

Study Registration Dates

• First Submitted: July 19, 2018
• First Submitted That Met QC Criteria: July 27, 2018
• First Posted (Actual): July 30, 2018

Study Record Updates

• Last Update Posted (Actual): July 30, 2018
• Last Update Submitted That Met QC Criteria: July 27, 2018
• Last Verified: July 1, 2018

More Information

Terms related to this study

• Keywords: type 1 diabetes; hypoglycemia unawareness; Insulin pump; Continuous glucose monitoring systems; Low glucose suspend
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Nervous System Diseases; Immune System Diseases; Autoimmune Diseases; Neurologic Manifestations; Neurobehavioral Manifestations; Endocrine System Diseases; Consciousness Disorders; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia; Unconsciousness
• Other Study ID Numbers: 2017Ao003

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No