- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02498054
Diabetic Mellitus Patients Glucose Range Awareness After Experiencing a New Blood Glucose Meter Feature
September 12, 2016 updated by: LifeScan
A single visit & single arm study in 80 subjects with diabetes to determine if a short educational experience with a new blood glucose meter feature improves the ability of each subject to better classify glucose results into acceptable glucose ranges.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Edinburgh, United Kingdom, EH16 4SA
- NHS Lothian
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Diagnosed with Type 1 diabetes Mellitus (T1DM) or Type 2 diabetes Mellitus (T2DM) for ≥ 3 months
- Currently performing self monitoring of blood glucose (SMBG) at home
- Aged ≥16 years
Exclusion Criteria:
- Previous use of any blood glucose meter with the colour range indicator feature to be evaluated in this study.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Education with new meter feature.
Subjects experience a computer stimulation of a new meter feature ( colour range indicator) to help subjects interpret whether blood glucose results are low, in-range or high based on accepted guidance.
|
The blood glucose meter has default settings for the colour range indicator which can be customized by the subjects and/or their healthcare professional.
This colour range indicator will be presented to the subjects as a computer simulation to show subjects a range of typical blood glucose values and how this new feature would classify these results as being low (blue), in-range (green) or high (red).
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Success rate to categorize blood glucose values into accepted ranges.
Time Frame: On average within 30 mins post intervention.
|
On average within 30 mins post intervention.
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Actual time taken to categorize blood glucose values into accepted ranges on the questionnaire provided.
Time Frame: On average within 30 mins post intervention.
|
On average within 30 mins post intervention.
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Mike Grady, Phd, LifeScan
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (Actual)
August 1, 2015
Study Completion (Actual)
August 1, 2015
Study Registration Dates
First Submitted
July 9, 2015
First Submitted That Met QC Criteria
July 14, 2015
First Posted (Estimate)
July 15, 2015
Study Record Updates
Last Update Posted (Estimate)
September 14, 2016
Last Update Submitted That Met QC Criteria
September 12, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- 3135718
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes Mellitus
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.CompletedDiabetes Mellitus, Type 1 | Type 1 Diabetes | Diabetes type1 | Type 1 Diabetes Mellitus | Autoimmune Diabetes | Diabetes Mellitus, Insulin-Dependent | Juvenile-Onset Diabetes | Diabetes, Autoimmune | Insulin-Dependent Diabetes Mellitus 1 | Diabetes Mellitus, Insulin-Dependent, 1 | Diabetes Mellitus, Brittle | Diabetes Mellitus, Juvenile-Onset and other conditionsUnited States
-
Guang NingRecruitingType 2 Diabetes Mellitus | Type1 Diabetes Mellitus | Monogenetic Diabetes | Pancreatogenic Diabetes | Drug-Induced Diabetes Mellitus | Other Forms of Diabetes MellitusChina
-
Medical College of WisconsinMedical University of South CarolinaCompletedDiabetes Mellitus | Type 2 Diabetes Mellitus | Adult-Onset Diabetes Mellitus | Non-Insulin-Dependent Diabetes Mellitus | Noninsulin Dependent Diabetes Mellitus, Type IIUnited States
-
Hanmi Pharmaceutical Company LimitedUnknownType2 Diabetes Mellitus | Type1 Diabetes MellitusUnited States
-
Meir Medical CenterCompletedDiabetes Mellitus Type 2 | Diabetes Mellitus, Non-insulin Dependant | Diabetes Mellitus, on Oral Hypoglycemic Treatment | Adult Type Diabetes MellitusIsrael
-
Peking Union Medical College HospitalUnknownType 2 Diabetes Mellitus | Type 1 Diabetes Mellitus | Gestational Diabetes Mellitus | Pancreatogenic Diabetes Mellitus | Pregestational Diabetes Mellitus | Diabetes Patients in Perioperative PeriodChina
-
SanofiCompletedType 1 Diabetes Mellitus-Type 2 Diabetes MellitusHungary, Russian Federation, Germany, Poland, Japan, United States, Finland
-
Joslin Diabetes CenterCambridge Medical Technologies, LLCCompletedType 2 Diabetes Mellitus | Type1 Diabetes MellitusUnited States
-
Medical University of South CarolinaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)CompletedDiabetes Mellitus, Type 2 | Diabetes Mellitus, Type II | Diabetes Mellitus, Adult-Onset | Diabetes Mellitus, Non-Insulin-Dependent | Diabetes Mellitus, Noninsulin DependentUnited States
-
Medical College of WisconsinMedical University of South Carolina; National Institute of Diabetes and Digestive...Active, not recruitingDiabetes Mellitus, Type 2 | Diabetes Mellitus, Type II | Diabetes Mellitus, Adult-Onset | Diabetes Mellitus, Non-Insulin-Dependent | Diabetes Mellitus, Noninsulin DependentUnited States
Clinical Trials on Education with new meter feature.
-
Fisher and Paykel HealthcareCompleted
-
Mahidol UniversityUnknownHypertension | Salt; ExcessThailand
-
Mahidol UniversityWorld Health Organization; Thai health promotion foundation.RecruitingHypertension | Salt; ExcessThailand
-
University of MichiganCompletedChild BehaviorUnited States
-
Edwards LifesciencesCompletedAbdominal Surgery | Pelvic Surgery | Non-Cardiac/ Non-Thoracic Surgery | Major Peripheral Vascular SurgeryUnited States
-
University of Eastern FinlandCompleted
-
Biotronik SE & Co. KGCompletedVentricular Fibrillation | Ventricular Tachycardia | Congestive Heart FailureDenmark, Germany, Israel, Australia, Austria, Czech Republic, Latvia
-
Abbott Medical DevicesActive, not recruitingParkinson DiseaseUnited States, Spain, Germany, United Kingdom
-
Hopital FochCompleted