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

NCT ID: NCT02225691

Last Updated: 2014-11-20

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 400 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2016-03-31

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.

Conditions

Diabetes Mellitus, Type 2; Diabetes Mellitus, Type 1

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Paired testing of blood glucose Accu-Chek®

Intervention Type: 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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: DEVICE

Other Intervention Names

Accu-Chek® Active blood glucose meters

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai 6th People's Hospital

OTHER

Sponsor Role: lead

Responsible Party

Weiping Jia

The director of the endocrinology and metabolism department of the Shanghai 6th People's Hospital

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Weiping Jia, MD, PHD

Role: PRINCIPAL_INVESTIGATOR

Shanghai 6th People's Hospital

Locations

Weiping Jia

Shanghai, , China

Countries

China

Central Contacts

Weiping Jia, MD,PHD

Role: CONTACT

wpjia@sjtu.edu.cn

＋8602164369181

Facility Contacts

Weiping Jia, MD,PHD

Role: primary

wpjia@sjtu.edu.cn

+8602164369181

References

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.

Reference Type: DERIVED

PMID: 30144264 (View on PubMed)

Other Identifiers

2014-32

Identifier Type: -

Identifier Source: org_study_id