Mobile Diabetes Management
Sponsor
University of Maryland, Baltimore (Other)
Overall Status
Completed
CT.gov ID
NCT01107015
Collaborator
(none)
213
1
4
39
5.5
Study Details
Study Description
Brief Summary
The Mobile Diabetes Intervention Study trial is evaluating a diabetes coaching system, using mobile phones and patient/ physician internet portals to allow patient-specific treatment and communication by their primary care physician. We hypothesize that timely information provided to patients and their physicians can result in reduction of A1c over 1 year.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Study Type:
Interventional
Actual Enrollment
:
213 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Investigator)
Primary Purpose:
Treatment
Official Title:
Mobile Diabetes Management
Study Start Date
:
Jun 1, 2008
Actual Primary Completion Date
:
Aug 1, 2010
Actual Study Completion Date
:
Sep 1, 2011
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Group 1: Usual Care Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG) |
|
| Active Comparator: Group 2: patient intervention Home diabetes monitoring by patient using mobile phone to communicate information and receive feedback |
Device: Tailored Patient Intervention
Patients select one of two mobile phone models, receive a one-year unlimited mobile phone data and phone service plan, receive the study treatment phone software and have access to the web-based individual patient portal. Given system-driven guidance on when to test blood glucose (bg) based on disease status, medication regimen, and time of poorest control. 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.
|
| Active Comparator: 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 |
Device: Patient-physician intervention
Patients select one of two mobile phone models, receive a one-year unlimited mobile phone data and phone service plan, receive the study treatment phone software and have access to the web-based individual patient portal. Given system-driven guidance on when to test blood glucose (bg) based on disease status, medication regimen, and time of poorest control. 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.
|
| Active Comparator: 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 |
Device: Patient and PCP intervention with analyzed data
Patients select one of two mobile phone models, receive a one-year unlimited mobile phone data and phone service plan, receive the study treatment phone software and have access to the web-based individual patient portal. Given system-driven guidance on when to test blood glucose (bg) based on disease status, medication regimen, and time of poorest control. 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.
|
Outcome Measures
Primary Outcome Measures
- HBA1c at One Year [one year]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 64 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
-
Type 2 diabetic [patient]
-
A1c equal to or greater than 7.5 [patient]
-
18-64 years of age at time of recruitment [patient]
-
Access to the internet (does not need to be at their home, elsewhere is fine e.g. work) [patient]
-
E-mail account [patient]
-
Must speak English [patient]
Exclusion Criteria:
-
No insulin pump [patient]
-
No current alcohol or drug abuse- must be sober 1 year [patient]
-
Not currently pregnant [patient]
-
No terminal diagnosis [patient]
-
No dementia or Alzheimer's [patient]
-
No active chemotherapy [patient]
-
No significant hearing impairment [patient]
-
Poorly corrected vision that would impede use of phone [patient]
-
No mute or aphasia [patient]
-
No diagnosis of schizophrenia, bipolar disorder, or major psychosis [patient]
-
No Medicaid or Medicare
-
No uninsured
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Maryland, Baltimore | Baltimore | Maryland | United States | 21201 |
Sponsors and Collaborators
- University of Maryland, Baltimore
Investigators
- Principal Investigator: Charlene C Quinn, RN, PhD, University of Maryland, Baltimore
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
Responsible Party:
Charlene C. Quinn,
Associate Professor,
University of Maryland, Baltimore
ClinicalTrials.gov Identifier:
NCT01107015
Other Study ID Numbers:
- HP-00041426
First Posted:
Apr 20, 2010
Last Update Posted:
Dec 11, 2019
Last Verified:
Dec 1, 2019
Keywords provided by Charlene C. Quinn,
Associate Professor,
University of Maryland, Baltimore
Additional relevant MeSH terms:
Study Results
Participant Flow
| Recruitment Details | |
|---|---|
| Pre-assignment Detail |
| Arm/Group Title | Group 1: Usual Care | Group 2: Patient Intervention | Group 3: Patient-physician Intervention | Group 4: Data Analyzed Intervention |
|---|---|---|---|---|
| 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 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 | 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 | 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 |
| Period Title: Overall Study | ||||
| STARTED | 62 | 38 | 33 | 80 |
| COMPLETED | 56 | 23 | 22 | 62 |
| NOT COMPLETED | 6 | 15 | 11 | 18 |
Baseline Characteristics
| Arm/Group Title | Group 1: Usual Care | Group 2: Patient Intervention | Group 3: Patient-physician Intervention | Group 4: Data Analyzed Intervention | Total |
|---|---|---|---|---|---|
| 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 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. | 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. | 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 of all reporting groups |
| Overall Participants | 56 | 23 | 22 | 62 | 163 |
| Age (Count of Participants) | |||||
| <=18 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Between 18 and 65 years |
56
100%
|
23
100%
|
22
100%
|
62
100%
|
163
100%
|
| >=65 years |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Age (years) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [years] |
53.2
(8.4)
|
52.8
(8.0)
|
53.7
(8.2)
|
52.0
(8.0)
|
52.8
(8.2)
|
| Sex: Female, Male (Count of Participants) | |||||
| Female |
28
50%
|
11
47.8%
|
10
45.5%
|
31
50%
|
80
49.1%
|
| Male |
28
50%
|
12
52.2%
|
12
54.5%
|
31
50%
|
83
50.9%
|
| Race (NIH/OMB) (Count of Participants) | |||||
| American Indian or Alaska Native |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Asian |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Native Hawaiian or Other Pacific Islander |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Black or African American |
27
48.2%
|
10
43.5%
|
10
45.5%
|
17
27.4%
|
64
39.3%
|
| White |
26
46.4%
|
12
52.2%
|
9
40.9%
|
39
62.9%
|
86
52.8%
|
| More than one race |
3
5.4%
|
1
4.3%
|
3
13.6%
|
6
9.7%
|
13
8%
|
| Unknown or Not Reported |
0
0%
|
0
0%
|
0
0%
|
0
0%
|
0
0%
|
| Region of Enrollment (Count of Participants) | |||||
| United States |
56
100%
|
23
100%
|
22
100%
|
62
100%
|
163
100%
|
| HbA1c (percentage of HbA1c) [Mean (Standard Deviation) ] | |||||
| Mean (Standard Deviation) [percentage of HbA1c] |
9.2
(1.7)
|
9.3
(1.8)
|
9.0
(1.8)
|
9.9
(2.1)
|
9.4
(2.0)
|
Outcome Measures
| Title | HBA1c at One Year |
|---|---|
| Description | |
| Time Frame | one year |
Outcome Measure Data
| Analysis Population Description |
|---|
| [Not Specified] |
| Arm/Group Title | Group 1: Usual Care | Group 2: Patient Intervention | Group 3: Patient-physician Intervention | Group 4: Data Analyzed Intervention |
|---|---|---|---|---|
| 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 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. | 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. | 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. |
| Measure Participants | 56 | 23 | 22 | 62 |
| Mean (Standard Deviation) [percentage of HbA1c] |
8.5
(1.8)
|
7.7
(1.0)
|
7.9
(1.4)
|
7.9
(1.7)
|
Statistical Analysis 1
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Usual Care, Group 2: Patient Intervention, Group 3: Patient-physician Intervention, Group 4: Data Analyzed Intervention |
|---|---|---|
| Comments | Linear mixed-effects models were used to compare mean changes in primary and secondary outcomes between UC and each active intervention. The primary analysis examined 12-month changes for glycated hemoglobin. Secondary analyses jointly compared 3-, 6-, 9-, and 12-month changes between groups. Random effects accounted for within-practice clustering and within-patient correlation. | |
| Type of Statistical Test | Other | |
| Comments | Sample size was determined on the basis of the primary outcome, change in glycated hemoglobin. The comparison of UC, which included 56 patients from nine practices, to CPDS, which included 62 patients from seven practices, had 80% power to detect a difference in mean glycated hemoglobin changes of 0.65 SD, corresponding to 1.0% if SD was 1.58%, using a two-sided test with 0.05 type I error after accounting for a within cluster correlation of 0.10. | |
| Statistical Test of Hypothesis | p-Value | 0.027 |
| Comments | CO (P = 0.027) and CPP (0.40) mean HbA1c levels decreased over 12 months. | |
| Method | Mixed Models Analysis | |
| Comments | ||
Statistical Analysis 2
| Statistical Analysis Overview | Comparison Group Selection | Group 1: Usual Care, Group 4: Data Analyzed Intervention |
|---|---|---|
| Comments | Linear mixed-effects models were used to compare mean changes in primary and secondary outcomes between UC and each active intervention. The primary analysis examined 12-month changes for glycated hemoglobin. | |
| Type of Statistical Test | Superiority | |
| Comments | ||
| Statistical Test of Hypothesis | p-Value | 0.001 |
| Comments | ||
| Method | Mixed Models Analysis | |
| Comments | ||
| Method of Estimation | Estimation Parameter | Mean Difference (Net) |
| Estimated Value | 0.05 | |
| Confidence Interval |
(2-Sided) % to |
|
| Parameter Dispersion |
Type: Value: |
|
| Estimation Comments | ||
Adverse Events
| Time Frame | One year intervention period. | |||||||
|---|---|---|---|---|---|---|---|---|
| Adverse Event Reporting Description | Participants were contacted monthly to inquire about adverse events. | |||||||
| Arm/Group Title | Group 1: Usual Care | Group 2: Patient Intervention | Group 3: Patient-physician Intervention | Group 4: Data Analyzed Intervention | ||||
| 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 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. | 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. | 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. | ||||
All Cause Mortality |
||||||||
| Group 1: Usual Care | Group 2: Patient Intervention | Group 3: Patient-physician Intervention | Group 4: Data Analyzed Intervention | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/62 (0%) | 0/38 (0%) | 0/33 (0%) | 0/80 (0%) | ||||
Serious Adverse Events |
||||||||
| Group 1: Usual Care | Group 2: Patient Intervention | Group 3: Patient-physician Intervention | Group 4: Data Analyzed Intervention | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/62 (0%) | 0/38 (0%) | 0/33 (0%) | 0/80 (0%) | ||||
Other (Not Including Serious) Adverse Events |
||||||||
| Group 1: Usual Care | Group 2: Patient Intervention | Group 3: Patient-physician Intervention | Group 4: Data Analyzed Intervention | |||||
| Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | Affected / at Risk (%) | # Events | |
| Total | 0/62 (0%) | 0/38 (0%) | 0/33 (0%) | 0/80 (0%) | ||||
Limitations/Caveats
[Not Specified]
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 | Univeristy of Maryland Baltimore |
| Phone | 4107062406 |
| cquinn@som.umaryland.edu |
Responsible Party:
Charlene C. Quinn,
Associate Professor,
University of Maryland, Baltimore
ClinicalTrials.gov Identifier:
NCT01107015
Other Study ID Numbers:
- HP-00041426
First Posted:
Apr 20, 2010
Last Update Posted:
Dec 11, 2019
Last Verified:
Dec 1, 2019