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

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

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.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
• Intervention / Treatment: Device: Paired testing of blood glucose Accu-Chek®

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 Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Weiping Jia, MD,PHD; Phone Number: +8602164369181; Email: wpjia@sjtu.edu.cn

Study Locations

• China
  • Shanghai, China, 200233
    • Weiping Jia
    • Contact: Weiping Jia, MD,PHD; Phone Number: +8602164369181; Email: wpjia@sjtu.edu.cn
    • Principal Investigator: Weiping Jia, MD,PHD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: paired testing of blood glucose; 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®; 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.; Other Names: Accu-Chek® Active blood glucose meters
No Intervention: control arm; 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?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Time Frame
Baseline change in quality of life score (based on Chinese Normal Audit of Diabetes-Dependent Quality of Life Questionnaire)	6 months
Baseline change in self-care scores (based on Diabetes Self-Efficacy Scale Questionnaire)	6 months

Collaborators and Investigators

• Sponsor: Shanghai 6th People's Hospital
• Investigators: Principal Investigator: Weiping Jia, MD, PhD, Shanghai 6th People's Hospital

Publications and helpful links

General Publications

• Shen Y, Zhu W, Lu L, Lu F, Kan K, Bao Y, Zhou J, Jia W. Contribution of structured self-monitoring of blood glucose to self-efficacy in poorly controlled diabetes patients in China. Diabetes Metab Res Rev. 2019 Jan;35(1):e3067. doi: 10.1002/dmrr.3067. Epub 2018 Sep 24.

Study record dates

Study Major Dates

• Study Start: December 1, 2014
• Primary Completion (Anticipated): September 1, 2015
• Study Completion (Anticipated): March 1, 2016

Study Registration Dates

• First Submitted: August 22, 2014
• First Submitted That Met QC Criteria: August 25, 2014
• First Posted (Estimate): August 26, 2014

Study Record Updates

• Last Update Posted (Estimate): November 20, 2014
• Last Update Submitted That Met QC Criteria: November 19, 2014
• Last Verified: November 1, 2014

More Information

Terms related to this study

• Keywords: type 2 diabetes; type 1 diabetes; paired testing
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1
• Other Study ID Numbers: 2014-32

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No