The primary objective of this pilot study is to determine the prevalence of (symptomatic) hypoglycaemia (
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Hypoglycemia < 3.0 mmol/L of at least 15 minutes.
Secondary outcome
- Hypoglycemia < 3.5 mmol/L of at least 15 minutes.
- Symptomatic hypoglycemia (<3.5 mmol/L of at least 15 minutes in combination
with complaints of hypoglycemia).
Background summary
There is very limited data regarding hypoglycaemia rates in elderly patients.
Randomised controlled trials often use age-specific inclusion criteria, or
age-related exclusion criteria such as frequent comorbidities. And those
elderly patients that are included in randomised trials are not representative
for all elderly patients with diabetes treated in primary care. Therefore, data
from observational studies are important, but again these data are lacking. The
aim of the current pilot study is to investigate to the prevalence of
(symptomatic) hypoglycaemia in frail elderly patients with type 2 diabetes
treated with sulphonylurea + metformin, and to gather data for a full-scale
hypothesis-testing study. The aim of this large powered study will be to
compare differences in the prevalence of hypoglycemic events between different
SUs.
Study objective
The primary objective of this pilot study is to determine the prevalence of
(symptomatic) hypoglycaemia (<3.0 mmol/L of at least 15 minutes) in
well-controlled (HbA1c <58 mmol/mol) frail elderly patients (>70 years) with
type 2 diabetes treated with sulphonylurea and metformin, or metformin
monotherapy.
Study design
A prospective observational cohort study.
Study burden and risks
Patients will have to perform SBGM (self blood glucose monitoring) and wear the
CGM for five days. In addition, besides the small risk of local infection at
site of needle insertion (for the CGMS), the risks from participating in this
trial are minimal.
Dokter van Heesweg 2 Dilleweg 15
Zwolle 8025 AB
NL
Dokter van Heesweg 2 Dilleweg 15
Zwolle 8025 AB
NL
Listed location countries
Age
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.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
| Register | ID |
|---|---|
| CCMO | NL51201.075.14 |
| OMON | NL-OMON21290 |