Effect of Paired Testing to Poorly Controlled Chinese Diabetes on Glycemic Control and Self Care

Shanghai Jiao Tong University

Status: Unknown

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Treatments: Device: Paired testing of blood glucose Accu-Chek®

Study type: Interventional

Funder types: Other

Identifiers

NCT02225691

2014-32

Details and patient eligibility

About

This study aims is to evaluate the effect of introducing paired testing on actual testing frequency, glycemic control, psychosocial and behavioural aspects of poorly controlled diabetes patients in China.

Full description

Self monitoring of blood glucose (SMBG) in insulin treated type 1 and type 2 diabetics has consistently been demonstrated to confer benefits, and is considered an essential part in the management of diabetes. In China, utilization of SMBG among diabetes patients is low. Even among those who perform SMBG regularly, the daily testing frequency falls short of those recommended in international and national clinical guidelines. There is thus a need to create the awareness of the benefits of SMBG and at the same time establish a SMBG regimen that is deemed practically feasible and cost effective for diabetes patients.

Paired testing entails the act of measuring glucose level before and after an event that may impact the glucose level in a patient, e.g. meals, exercise, medication adjustment, and thereafter responding to any abnormal glucose levels/patterns by modifying lifestyle and/or medication.

This study aims is to evaluate the effect of introducing paired testing on actual testing frequency, glycemic control, psychosocial and behavioral aspects of poorly controlled diabetes patients in China.

Enrollment: 400 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed with diabetes mellitus
• HbA1c ≥ 8% measured within the a month prior to enrolment
• Have not been performing SMBG on a regular (daily) basis within the 3 months prior to enrolment
• Willing and able to use Accu-Chek® Active blood glucose meter to perform daily SMBG
• Willing and able to complete participant questionnaires
• Willing and able to visit the physician at month 3 and month 6
• Provide informed consent prior to enrolling in the study

Exclusion criteria

• Any retinopathy that required photocoagulation or retinal surgery in the 6 months prior to enrolment or that may require photocoagulation or retinal surgery during the study
• Any clinically significant condition that required hospitalization in the last 2 months prior to enrolment or that may require hospitalization (e.g. elective surgery) during the study
• Any clinically significant psychosis or cognitive impairment
• Unlikelihood to comply or complete the study
• Women who are pregnant, lactating or planning to become pregnant during the study period

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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400 participants in 2 patient groups

paired testing of blood glucose

Experimental group

Description:

Patient will be randomly assigned to one of 2 arms, namely (i) paired testing (PT) arm; and (ii) control (CL) arm. Paired testing arm will undergo paired testing of blood glucose.

Treatment:

Device: Paired testing of blood glucose Accu-Chek®

control arm

No Intervention group

Description:

Non-insulin patients will be randomly assigned to one of 2 arms, namely (i) paired testing (PT) arm; and (ii) control (CL) arm. Patients in the control arms will not undergo paired testing and will be managed as before.