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

Smart Glucose Meter Project

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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)
Enrollment 14

Recruitment Details  
Pre-assignment Details  
Arm/Group Title Control Intervention
Hide Arm/Group Description Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG)

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

Period Title: Overall Study
Started 4 10
Completed 0 0
Not Completed 4 10
Reason Not Completed
Lost to Follow-up             2             0
stopped using the meters             2             10
Arm/Group Title Control Intervention Total
Hide Arm/Group Description Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG)

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 of all reporting groups
Overall Number of Baseline Participants 4 10 14
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 4 participants 10 participants 14 participants
51.3  (18) 52.8  (13.4) 52.3  (14.1)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 10 participants 14 participants
Female
2
  50.0%
4
  40.0%
6
  42.9%
Male
2
  50.0%
6
  60.0%
8
  57.1%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 4 participants 10 participants 14 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  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 4 participants 10 participants 14 participants
4
 100.0%
10
 100.0%
14
 100.0%
1.Primary Outcome
Title Change in HbA1c
Hide Description Determine whether this intervention leads to significant improvements in patient HbA1c from baseline to 6 months
Time Frame 6 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Results for change were not collected because the study was stopped. Participants were lost to follow-up and stopped using the meters
Arm/Group Title Control Intervention
Hide Arm/Group Description:
Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG)

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

Overall Number of Participants Analyzed 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Control Intervention
Hide Arm/Group Description Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG)

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

All-Cause Mortality
Control Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Control Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/10 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 1%
Control Intervention
Affected / at Risk (%) Affected / at Risk (%)
Total   0/4 (0.00%)   0/10 (0.00%) 
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
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