Clinical trial NCT02225691: Effect of Paired Testing to Poorly Controlled Chinese Diabetes on Glycemic Control and Self Care
Official title: Effect of Introducing Daily Paired Testing to Poorly Controlled Chinese Diabetes Patients on Glycemic Control and Self Care
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Keywords: type 1 diabetes
type 2 diabetes
paired testing
Lead sponsor: Shanghai 6th People's Hospital
Sponsor class: OTHER
First posted: 2014-08-26
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Baseline change in HbA1c at month 3 and 6 between paired testing and control arms for each of the 3 patient segments.
timeFrame: 6 months
Secondary outcomes:
measure: Proportion of patients who achieve good glycemic control (HbA1c≤7%)
timeFrame: 6 months
Other outcomes:
measure: Baseline change in quality of life score (based on Chinese Normal Audit of Diabetes-Dependent Quality of Life Questionnaire)
timeFrame: 6 months
measure: Baseline change in self-care scores (based on Diabetes Self-Efficacy Scale Questionnaire)
timeFrame: 6 months
Locations:
city: Shanghai
country: China
facility: Weiping Jia
Study officials:
affiliation: Shanghai 6th People's Hospital
name: Weiping Jia, MD, PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.