Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2
Conditions
Keywords
type 1 diabetes, type 2 diabetes, paired testing
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.
Interventions
DEVICEPaired 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.
Sponsors
Shanghai 6th People's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| 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
| Measure | Time frame |
|---|---|
| Proportion of patients who achieve good glycemic control (HbA1c≤7%) | 6 months |
Other
| 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 |
Countries
China
Contacts
Primary ContactWeiping Jia, MD,PHD
Outcome results
None listed