An interventional study of Paired testing of blood glucose Accu-Chek® in Diabetes Mellitus, Type 2 and Diabetes Mellitus, Type 1, sponsored by Shanghai 6th People's Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2014-11-20.
Sponsored by Shanghai 6th People's Hospital · Not applicable, Interventional, and Supportive 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.
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.
10,925 studies on the registry are indexed under Diabetes Mellitus; 1,319 are open to participants now.
This study's planned enrollment of 400 is above the median of 80 across 8,367 interventional studies indexed under Diabetes Mellitus.
Browse Diabetes Mellitus studies →Shanghai 6th People's Hospital is the lead sponsor of 69 studies on the registry; 40 are open to participants now.
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Exclusion Criteria:
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®
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.
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.
Also known as: Accu-Chek® Active blood glucose meters
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
This study is status unknown, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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Shanghai 6th People's Hospital