Blood Glucose Self Monitoring and HbA1c Effects on Glucose Control

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-02-28

Study Completion Date

2008-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this randomized, prospective trial is to determine wether (a) a once weekly glucose profile (self monitoring) or (b) a three-monthly report of the actual glycated haemoglobin are effective interventions to improve HbA1c after one year in typ 2-diabetic patients on conventional insulin treatment.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Impact of Self-Monitoring Blood Glucose Frequency on Glycemic Control in Patients With Type 2 Diabetes

NCT00202033

Type 2 Diabetes

COMPLETED PHASE4

Self-monitoring of Blood Glucose in Insulin-treated Patients With Type 2 Diabetes

NCT01460459

Diabetes Mellitus, Type 2

UNKNOWN NA

Effect on HbA1c of the Initiation of CGM in Adults With Type 2 Diabetes Treated With Basal Insulin in Finland

NCT06268821

Type 2 Diabetes Treated With Insulin

TERMINATED NA

Effect of Self-monitoring of Blood Glucose in Patients With Type 2 Diabetes Mellitus Not Using Insulin

NCT00287807

Diabetes Mellitus, Type 2

COMPLETED PHASE3

Periodic Continuous Glucose Monitoring in Patients With Type 2 Diabetes

NCT05633628

Type 2 Diabetes

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

The design is an open, prospective, randomised, multicentre parallel group study. The total duration will be 5 years with patient recruitment over 4 years and an individual observation period of 1 year. 300 participants from 43 study centres, hospitals and private practices were recruited. The study will run for one year and aims to determine, whether there is an advantage with regard to HbA1c levels when (a) a regular three-monthly HbA1c or (b) a weekly 4-point glucose profile is taken and reported.

After screening, patients will be assigned at random to one of the following study arms:

1. no regular blood-glucose self-monitoring, no regular HbA1c
2. regular blood glucose self monitoring, no regular HbA1c
3. no regular blood glucose self monitoring, regular HbA1c
4. regular blood glucose self monitoring, regular HbA1c

The control for all participants is that urinary glucose should be monitored at least once a day, preferably in the late morning, as the highest increase in plasma glucose level occurs after breakfast.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Type 2 Diabetes

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

No blood-glucose self-control, no HbA1c

Group Type EXPERIMENTAL