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

Shanghai 6th People's Hospital400 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

400

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1

Interventions

Paired testing of blood glucose Accu-Chek®DEVICE

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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

Locations (1)

Weiping Jia

Shanghai, China

Outcomes

Primary Outcomes

Baseline change in HbA1c at month 3 and 6 between paired testing and control arms for each of the 3 patient segments.

Time frame: 6 months

Secondary Outcomes

Proportion of patients who achieve good glycemic control (HbA1c≤7%)

Time frame: 6 months

Central Contacts

Weiping Jia, MD,PHD

CONTACT

＋8602164369181 wpjia@sjtu.edu.cn

Data from ClinicalTrials.gov

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