Effect of Paired Testing to Poorly Controlled Chinese Diabetes on Glycemic Control and Self Care
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|ClinicalTrials.gov Identifier: NCT02225691|
Recruitment Status : Unknown
Verified November 2014 by Weiping Jia, Shanghai 6th People's Hospital.
Recruitment status was: Not yet recruiting
First Posted : August 26, 2014
Last Update Posted : November 20, 2014
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1||Device: Paired testing of blood glucose Accu-Chek®||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||400 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Effect of Introducing Daily Paired Testing to Poorly Controlled Chinese Diabetes Patients on Glycemic Control and Self Care|
|Study Start Date :||December 2014|
|Estimated Primary Completion Date :||September 2015|
|Estimated Study Completion Date :||March 2016|
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 Name: 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.
- 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 ]
- Proportion of patients who achieve good glycemic control (HbA1c≤7%) [ Time Frame: 6 months ]
- Baseline change in quality of life score (based on Chinese Normal Audit of Diabetes-Dependent Quality of Life Questionnaire) [ Time Frame: 6 months ]
- Baseline change in self-care scores (based on Diabetes Self-Efficacy Scale Questionnaire) [ Time Frame: 6 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02225691
|Contact: Weiping Jia, MD,PHD||＋email@example.com|
|Weiping Jia||Not yet recruiting|
|Shanghai, China, 200233|
|Contact: Weiping Jia, MD,PHD +8602164369181 firstname.lastname@example.org|
|Principal Investigator: Weiping Jia, MD,PHD|
|Principal Investigator:||Weiping Jia, MD, PHD||Shanghai 6th People's Hospital|