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Safety and Efficacy of the GlucoMe APP in Patients With Uncontrolled Diabetes Treated With MDI

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03017287
Recruitment Status : Terminated (Poor accrual)
First Posted : January 11, 2017
Last Update Posted : September 23, 2020
Information provided by (Responsible Party):

Brief Summary:
The study will evaluate the safety and efficacy of computerized GlucoMe App in patients with uncontrolled diabetes treated with MDI.

Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 or 2 Device: GlucoMe App Not Applicable

Detailed Description:

GlucoMe is an interactive system, which provides glucose management tools to both the patient and health care team (HCT). The system includes a decision support system to be used by the HCT aiming to aid clinical decision making with mathematical models. The system does not intend to replace clinical judgement and all recommendations are to be approved by the HCT.

Forty (40) diabetic patients on multiple daily insulin injection (MDI) with abnormal HbA1c and identified as potential end users of the device will be recruited to the study and screened according to the study inclusion and exclusion criteria. Patient's daily blood glucose will be measured and the GlucoMe App will give its recommendations for change in insulin dose, as well as recommendations for pre and post-meal carbohydrate and exercise. Patient's daily blood glucose levels will be followed by the HCT biweekly for 12 weeks and patients will be instructed to change their insulin doses according to the decision of the treating physician. At the end of the study, the HCT's recommendations for treatment adjustment will be compared to those of the system for both safety and efficacy. Study subjects and the HCT will be asked to complete a questionnaire regarding the GlucoMe system usability.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Safety and Efficacy of the GlucoMe APP in Patients With Uncontrolled Diabetes Treated With MDI
Study Start Date : January 2017
Actual Primary Completion Date : May 2017
Actual Study Completion Date : August 2017

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: GlucoMe App
Self monitoring of glucose blood measurements using the GlucoMe glucose monitoring glucose device and App
Device: GlucoMe App
Assessment of the the GlucoMe App

Primary Outcome Measures :
  1. Hypoglycemic and Hyperglycemic Events [ Time Frame: At 12 weeks of the study ]
    Number and severity of hypoglycemic and severe hyperglycemic events

  2. Correlation between GlucoMe and HCT recommendations [ Time Frame: At 12 weeks of the study ]
    Correlation between GlucoMe and HCT recommendations for changing insulin dose and the treating physician/HCT advice.

Secondary Outcome Measures :
  1. Target HbA1C/glucose achievement [ Time Frame: At 12 weeks of the study ]
    Percent of patients that achieve HbA1C/glucose targets

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

Inclusion Criteria:

  1. Both type 1 and type 2 diabetes
  2. HbA1c 7-11%
  3. Treated with MDI for at least 3 months
  4. Ability to use the system at home, mobile phone

Exclusion Criteria:

  1. Active CAD, CVA during last 6 months
  2. Treatment with steroids or other glucose modifying drugs
  3. Chronic infection/cancer/other severe disease

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 identifier (NCT number): NCT03017287

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Diabitic Unit of the Wolfson Medical Center
Holon, Israel
Sponsors and Collaborators
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Responsible Party: GlucoMe Identifier: NCT03017287    
Other Study ID Numbers: Clin-002-00
First Posted: January 11, 2017    Key Record Dates
Last Update Posted: September 23, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by GlucoMe:
Glucose blood measurements, glucometer, BGM, Diabetes App
Additional relevant MeSH terms:
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Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases