Trial Outcomes & Findings for Mobile Diabetes Management (NCT NCT01107015)
NCT ID: NCT01107015
Last Updated: 2023-05-31
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
213 participants
Primary outcome timeframe
one year
Results posted on
2023-05-31
Participant Flow
Participant milestones
| Measure |
Group 1: Usual Care
Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG)
|
Group 2: Patient Intervention
Home diabetes monitoring by patient using mobile phone to communicate information and receive feedback
Patients may provide their PCPs with printed copies of their logbooks and other information but physicians do not have access to the patient portal system. Patient action plans summarizing the patient-entered data and identif
|
Group 3: Patient-physician Intervention
Home diabetes monitoring by patient using mobile phone to communicate and receive feedback; Physician can access unanalyzed information from the patient's electronic logbook
PCPs are provided access to a web portal where they may choose to review their patients' electronic logbooks. This is "raw" patient data that have not be
|
Group 4: Data Analyzed Intervention
Home diabetes monitoring by patient using mobile phone to communicate information and receive feedback; Physician can access raw and analyzed patient data; Physician receives report summary and treatment recommendations
Patient and PCP intervention with analyzed data: Messages are sent to the patient's mobile phone giving feedback on entered data. Entered data are captured in real-time in the web-based logbook. PCPs are provided access to a secure web portal where they can see their patients' electro
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
62
|
38
|
33
|
80
|
|
Overall Study
COMPLETED
|
56
|
23
|
22
|
62
|
|
Overall Study
NOT COMPLETED
|
6
|
15
|
11
|
18
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mobile Diabetes Management
Baseline characteristics by cohort
| Measure |
Group 1: Usual Care
n=56 Participants
Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG)
|
Group 2: Patient Intervention
n=23 Participants
Home diabetes monitoring by patient using mobile phone to communicate information and receive feedback
Tailored Patient Intervention: Patients enter bg data, carbohydrates consumed, diabetes medications taken. Messages are sent to the patient's mobile phone giving feedback on entered data. Entered data are captured in real-time in the web-based logbook. Patients may provide their PCPs with printed copies of their logbooks and other information but physicians do not have access to the patient portal system. Patient action plans summarizing the patient-entered data and identifying possible self-management actions for improving their diabetes control are electronically sent to the patients every 2.5 months.
|
Group 3: Patient-physician Intervention
n=22 Participants
Home diabetes monitoring by patient using mobile phone to communicate and receive feedback; Physician can access unanalyzed information from the patient's electronic logbook
Patient-physician intervention: . Patients enter bg data, carbohydrates consumed, diabetes medications taken and miscellaneous comments regarding diabetes self-care. Messages are sent to the patient's mobile phone giving feedback on entered data. PCPs are provided access to a web portal. This is "raw" patient data that have not been analyzed.
|
Group 4: Data Analyzed Intervention
n=62 Participants
Home diabetes monitoring by patient using mobile phone to communicate information and receive feedback; Physician can access raw and analyzed patient data; Physician receives report summary and treatment recommendations
Patient and PCP intervention with analyzed data:Patients enter bg data, carbohydrates consumed, diabetes medications taken and miscellaneous comments regarding diabetes self-care. Messages are sent to the patient's mobile phone giving feedback on entered data. Entered data are captured in real-time in the web-based logbook. PCPs are provided access to a secure web portal where they can see their patients' electro
|
Total
n=163 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
56 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
62 Participants
n=7 Participants
|
163 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Continuous
|
53.2 years
STANDARD_DEVIATION 8.4 • n=99 Participants
|
52.8 years
STANDARD_DEVIATION 8.0 • n=107 Participants
|
53.7 years
STANDARD_DEVIATION 8.2 • n=206 Participants
|
52.0 years
STANDARD_DEVIATION 8.0 • n=7 Participants
|
52.8 years
STANDARD_DEVIATION 8.2 • n=31 Participants
|
|
Sex: Female, Male
Female
|
28 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
31 Participants
n=7 Participants
|
80 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
31 Participants
n=7 Participants
|
83 Participants
n=31 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Black or African American
|
27 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
17 Participants
n=7 Participants
|
64 Participants
n=31 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
39 Participants
n=7 Participants
|
86 Participants
n=31 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
6 Participants
n=7 Participants
|
13 Participants
n=31 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Region of Enrollment
United States
|
56 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
62 Participants
n=7 Participants
|
163 Participants
n=31 Participants
|
|
HbA1c
|
9.2 percentage of HbA1c
STANDARD_DEVIATION 1.7 • n=99 Participants
|
9.3 percentage of HbA1c
STANDARD_DEVIATION 1.8 • n=107 Participants
|
9.0 percentage of HbA1c
STANDARD_DEVIATION 1.8 • n=206 Participants
|
9.9 percentage of HbA1c
STANDARD_DEVIATION 2.1 • n=7 Participants
|
9.4 percentage of HbA1c
STANDARD_DEVIATION 2.0 • n=31 Participants
|
PRIMARY outcome
Timeframe: one yearOutcome measures
| Measure |
Group 1: Usual Care
n=56 Participants
Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG)
|
Group 2: Patient Intervention
n=23 Participants
Home diabetes monitoring by patient using mobile phone to communicate information and receive feedback
Tailored Patient Intervention: Patients enter bg data, carbohydrates consumed, diabetes medications taken and miscellaneous comments regarding diabetes self-care. Messages are sent to the patient's mobile phone giving feedback on entered data. Entered data are captured in real-time in the web-based logbook. Patients may provide their PCPs with printed copies of their logbooks and other information but physicians do not have access to the patient portal system. Patient action plans summarizing the patient-entered data and identifying possible self-management actions for improving their diabetes control are electronically sent to the patients every 2.5 months.
|
Group 3: Patient-physician Intervention
n=22 Participants
Home diabetes monitoring by patient using mobile phone to communicate and receive feedback; Physician can access unanalyzed information from the patient's electronic logbook
Patient-physician intervention: Patients enter bg data, carbohydrates consumed, diabetes medications taken and miscellaneous comments regarding diabetes self-care. Messages are sent to the patient's mobile phone giving feedback on entered data. Entered data are captured in real-time in the web-based logbook. PCPs are provided access to a web portal where they may choose to review their patients' electronic logbooks. This is "raw" patient data that have not been analyzed.
|
Group 4: Data Analyzed Intervention
n=62 Participants
Home diabetes monitoring by patient using mobile phone to communicate information and receive feedback; Physician can access raw and analyzed patient data; Physician receives report summary and treatment recommendations
Patient and PCP intervention with analyzed data: Patients enter bg data, carbohydrates consumed, diabetes medications taken and miscellaneous comments regarding diabetes self-care. Messages are sent to the patient's mobile phone giving feedback on entered data. Entered data are captured in real-time in the web-based logbook. PCPs are provided access to a secure web portal where they can see their patients' electronic logbooks. PCPs are provided with data analysis reports. The PCP is reminded that all data analysis is based on patient-entered, unvalidated data. The PCP has the option to use this information and remains responsible for all treatment decisions.
|
|---|---|---|---|---|
|
HBA1c at One Year
|
8.5 percentage of HbA1c
Standard Deviation 1.8
|
7.7 percentage of HbA1c
Standard Deviation 1.0
|
7.9 percentage of HbA1c
Standard Deviation 1.4
|
7.9 percentage of HbA1c
Standard Deviation 1.7
|
Adverse Events
Group 1: Usual Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 2: Patient Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 3: Patient-physician Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Group 4: Data Analyzed Intervention
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Cindy Geppi
University of Maryland, Baltimore
Phone: 4107062406
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place