ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 15 of 50 for:    diabetes type 1 AND (woman OR women OR female) AND blood glucose

Smart Glucose Meter Project

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.
ClinicalTrials.gov Identifier: NCT01341587
Recruitment Status : Terminated (participants lost to follow-up;)
First Posted : April 25, 2011
Results First Posted : March 12, 2018
Last Update Posted : March 12, 2018
Sponsor:
Collaborators:
Maryland Industrial Partnerships
Telcare, Inc
Information provided by (Responsible Party):
Charlene C. Quinn, University of Maryland

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions: Type 1 Diabetes
Type 2 Diabetes
Intervention: Device: Telcare Blood Glucose Meter (BGM)

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Control Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG)
Intervention

Home diabetes monitoring by patient using cellular enabled glucometer to communicate information and receive feedback.

Care provider can access raw and analyzed patient data; Physician receives report summary.

Telcare Blood Glucose Meter (BGM): Cellular enabled glucometer


Participant Flow:   Overall Study
    Control   Intervention
STARTED   4   10 
COMPLETED   0   0 
NOT COMPLETED   4   10 
Lost to Follow-up                2                0 
stopped using the meters                2                10 



  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Control Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG)
Intervention

Home diabetes monitoring by patient using cellular enabled glucometer to communicate information and receive feedback.

Care provider can access raw and analyzed patient data; Physician receives report summary.

Telcare Blood Glucose Meter (BGM): Cellular enabled glucometer

Total Total of all reporting groups

Baseline Measures
   Control   Intervention   Total 
Overall Participants Analyzed 
[Units: Participants]
 4   10   14 
Age 
[Units: Years]
Mean (Standard Deviation)
 51.3  (18)   52.8  (13.4)   52.3  (14.1) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      2  50.0%      4  40.0%      6  42.9% 
Male      2  50.0%      6  60.0%      8  57.1% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
     
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0% 
Black or African American      4 100.0%      9  90.0%      13  92.9% 
White      0   0.0%      1  10.0%      1   7.1% 
More than one race      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
United States   4   10   14 


  Outcome Measures

1.  Primary:   Change in HbA1c   [ Time Frame: 6 months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information

Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Charlene C. Quinn
Organization: University of Maryland Baltimore
phone: 4107062406
e-mail: cquinn@som.umaryland.edu



Responsible Party: Charlene C. Quinn, University of Maryland
ClinicalTrials.gov Identifier: NCT01341587     History of Changes
Other Study ID Numbers: HP-00045527
First Submitted: February 7, 2011
First Posted: April 25, 2011
Results First Submitted: February 8, 2018
Results First Posted: March 12, 2018
Last Update Posted: March 12, 2018