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Continuous glucose monitoring in well-controlled elderly patients with type 2 Diabetes Mellitus.


- candidate number21575
- NTR NumberNTR4952
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-jan-2015
- Secondary IDsNL51201.075.14 
- Public TitleContinuous glucose monitoring in well-controlled elderly patients with type 2 Diabetes Mellitus.
- Scientific TitleThe prevalence of (symptomatic) hypoglycemia in well-controlled elderly patients with type 2 Diabetes Mellitus: the results of continuous glucose monitoring. An observational pilot study.
- ACRONYM-
- hypothesisThe aim of the current pilot study is to investigate the prevalence of (symptomatic) hypoglycaemia in frail elderly patients with type 2 diabetes treated with sulfonylurea and 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 the most commonly used sulfonylurea derivatives (SUs), glimepiride and gliclazide.
- Healt Condition(s) or Problem(s) studiedDiabetes Mellitus Type 2 (DM type II), Hypoglycemia, Elderly patients
- Inclusion criteria- known type 2 diabetes mellitus; - >70 years old; - HbA1c <58 mmol/mol; - Groningen Frailty Indicator score ≥4; - treatment with: metformin only (any dosage); or metformin (any dosage) + gliclazide (any dosage); or metformin (any dosage) + glimepiride (any dosage).
- Exclusion criteria- insufficient knowledge of the Dutch language to understand the requirements of the study; - advanced dementia; - known anemia; - terminally ill or an estimated life expectancy <3 months.
- mec approval receivedyes
- multicenter trialyes
- randomisedno
- group[default]
- Type[default]
- Studytypeobservational
- planned startdate 11-dec-2014
- planned closingdate11-mei-2015
- Target number of participants15
- InterventionsN/A
- Primary outcomeHypoglycaemia < 3.0 mmol/L of at least 15 minutes.
- Secondary outcomeHypoglycaemia < 3.5 mmol/L of at least 15 minutes. Symptomatic hypoglycaemia (<3.5 mmol/L of at least 15 minutes in combination with complaints of hypoglycaemia).
- TimepointsVisit 1: inclusion, informed consent, blood drawn for HbA1c measurement, Groningen Frailty index. Visit 2 (day 1): baseline measurements, blood pressure measurements, CGMS implanted. Day 1: CGMS implanted after breakfast, SMBG (4-5x); Day 2: SMBG (N, VL, VA, VS); Day 3: SMBG (N, VL, VA, VS); Day 4: SMBG (N, VL, VA, VS); Visit 3 (day 5): removal of CGMS, collection of patient diary.
- Trial web site-
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES A.J. Bouma
- CONTACT for SCIENTIFIC QUERIESdr. K.J.J. van Hateren
- Sponsor/Initiator Diabetes Centre, Isala
- Funding
(Source(s) of Monetary or Material Support)
- Publications-
- Brief summaryThe current national primary care guideline recommends gliclazide as the second pharmacological step in diabetes management. Unfortunately, there is very limited data regarding hypoglycaemia rates in elderly patients using SUs. As more than one quarter of the type 2 diabetes population in the Netherlands is older than 75 years, differences in the frequency of hypoglycaemic events between SUs could be relevant. These events can be easily reported by the CGMS. Previous studies with CGMS already showed us that (asymptomatic) hypoglycaemic events are easily missed in elderly patients. However, these studies did not use an appropriate control group. Data regarding the effects of SUs, and specifically gliclazide, are needed for confirming the safety of gliclazide in frail elderly patients treated in primary care.
- Main changes (audit trail)
- RECORD14-jan-2015 - 23-feb-2015


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