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

Not Applicable

• Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
• Interventions: Device: Paired testing of blood glucose Accu-Chek®

• Registration Number: NCT02225691
• Lead Sponsor: Shanghai 6th People's Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2014-08-22
• Study First Submitted QC: 2014-08-25
• Study First Posted: 2014-08-26
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-19
• Last Update Posted: 2014-11-20
• Study Start: 2014-12
• Primary Completion: 2015-09
• Study Completion: 2016-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
paired testing of blood glucose	Paired testing of blood glucose Accu-Chek®	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.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
Proportion of patients who achieve good glycemic control (HbA1c≤7%)	6 months

Trial Locations

Locations (1)

Weiping Jia; 🇨🇳 Shanghai, China