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

Primary Purpose

Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Paired testing of blood glucose Accu-Chek®
Sponsored by
Shanghai 6th People's Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Diabetes Mellitus, Type 2 focused on measuring type 1 diabetes, type 2 diabetes, paired testing

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Weiping Jia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

paired testing of blood glucose

control arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Baseline change in HbA1c at month 3 and 6 between paired testing and control arms for each of the 3 patient segments.

Secondary Outcome Measures

Proportion of patients who achieve good glycemic control (HbA1c≤7%)

Full Information

First Posted
August 22, 2014
Last Updated
November 19, 2014
Sponsor
Shanghai 6th People's Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02225691
Brief Title
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

2. Study Status

Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
December 2014 (undefined)
Primary Completion Date
September 2015 (Anticipated)
Study Completion Date
March 2016 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Shanghai 6th People's Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2, Diabetes Mellitus, Type 1
Keywords
type 1 diabetes, type 2 diabetes, paired testing

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
paired testing of blood glucose
Arm Type
Experimental
Arm Description
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.
Arm Title
control arm
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Paired testing of blood glucose Accu-Chek®
Other Intervention Name(s)
Accu-Chek® Active blood glucose meters
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
Proportion of patients who achieve good glycemic control (HbA1c≤7%)
Time Frame
6 months
Other Pre-specified Outcome Measures:
Title
Baseline change in quality of life score (based on Chinese Normal Audit of Diabetes-Dependent Quality of Life Questionnaire)
Time Frame
6 months
Title
Baseline change in self-care scores (based on Diabetes Self-Efficacy Scale Questionnaire)
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Weiping Jia, MD,PHD
Phone
＋8602164369181
Email
wpjia@sjtu.edu.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Weiping Jia, MD, PHD
Organizational Affiliation
Shanghai 6th People's Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Weiping Jia
City
Shanghai
ZIP/Postal Code
200233
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Weiping Jia, MD,PHD
Phone
+8602164369181
Email
wpjia@sjtu.edu.cn
First Name & Middle Initial & Last Name & Degree
Weiping Jia, MD,PHD

12. IPD Sharing Statement

Citations:
PubMed Identifier
30144264
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.
Results Reference
derived

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

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