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The prevalence of (symptomatic) hypoglycemia in well-controlled elderly patients with type 2 Diabetes Mellitus: the results of continuous glucose monitoring. An observational pilot study.

Completed
Conditions
Diabetes
10018424
Registration Number
NL-OMON42250
Lead Sponsor
Isala Klinieken
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Completed
Sex
Not specified
Target Recruitment
25
Inclusion Criteria

Patients are required to meet the following criteria:
o known T2DM;
o >70 years old;
o HbA1c <58 mmol/mol;
o Groningen Frailty Indicator score >=4;
o treatment with
* metformin only (any dosage); or
* metformin (any dosage) + gliclazide (any dosage); or
* metformin (any dosage) + glimepiride (any dosage).

Exclusion Criteria

Patients with insufficient knowledge of the Dutch language to understand the requirements of the study, patients with advanced dementia, patients with known anemia, and patients with a terminal disease or an estimated life expectancy <3 months, will be excluded.

Study & Design

Study Type
Observational invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>Hypoglycemia < 3.0 mmol/L of at least 15 minutes.</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>- Hypoglycemia < 3.5 mmol/L of at least 15 minutes.<br /><br>- Symptomatic hypoglycemia (<3.5 mmol/L of at least 15 minutes in combination<br /><br>with complaints of hypoglycemia).</p><br>
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