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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Effect of Introducing Daily Paired Testing to Poorly Controlled Chinese Diabetes Patients on Glycemic Control and Self Care

Conditions
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Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1

Intervention / Treatment
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* Device: Paired testing of blood glucose Accu-Chek®


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: paired testing of blood glucose<br>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. | Device: Paired testing of blood glucose Accu-Chek®<br>* Patients in the paired testing arms will undergo training on paired testing with Accu-Chek® Active blood glucose meters. The paired testing training would include (1) how and when (testing regimen) to perform paired testing, and (2) how to respond to paired testing readings via lifestyle modifications, self-adjustment of insulin dose and additional testing, if applicable. Please refer to Annex A for further details of the training.<br>* Other names: Accu-Chek® Active blood glucose meters;|
| No Intervention: control arm<br>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. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Baseline change in HbA1c at month 3 and 6 between paired testing and control arms for each of the 3 patient segments. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who achieve good glycemic control (HbA1c≤7%) |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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type 1 diabetes, type 2 diabetes, paired testing