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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
Sponsor:
Information provided by (Responsible Party):
Weiping Jia, Shanghai 6th People's Hospital

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.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 2 Diabetes Mellitus, Type 1 Device: Paired testing of blood glucose Accu-Chek® Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
Allocation: Randomized
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Blood Sugar
Drug Information available for: Dextrose

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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 Measures :
  1. Proportion of patients who achieve good glycemic control (HbA1c≤7%) [ Time Frame: 6 months ]

Other Outcome Measures:
  1. Baseline change in quality of life score (based on Chinese Normal Audit of Diabetes-Dependent Quality of Life Questionnaire) [ Time Frame: 6 months ]
  2. Baseline change in self-care scores (based on Diabetes Self-Efficacy Scale Questionnaire) [ Time Frame: 6 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

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


Contacts
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Contact: Weiping Jia, MD,PHD +8602164369181 wpjia@sjtu.edu.cn

Locations
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China
Weiping Jia Not yet recruiting
Shanghai, China, 200233
Contact: Weiping Jia, MD,PHD    +8602164369181    wpjia@sjtu.edu.cn   
Principal Investigator: Weiping Jia, MD,PHD         
Sponsors and Collaborators
Shanghai 6th People's Hospital
Investigators
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Principal Investigator: Weiping Jia, MD, PHD Shanghai 6th People's Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Weiping Jia, The director of the endocrinology and metabolism department of the Shanghai 6th People's Hospital, Shanghai 6th People's Hospital
ClinicalTrials.gov Identifier: NCT02225691     History of Changes
Other Study ID Numbers: 2014-32
First Posted: August 26, 2014    Key Record Dates
Last Update Posted: November 20, 2014
Last Verified: November 2014

Keywords provided by Weiping Jia, Shanghai 6th People's Hospital:
type 1 diabetes
type 2 diabetes
paired testing

Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 2
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases