Diabetes
Conditions
Keywords
Diabetes, Glucose control, Diabetes monitoring, Care management, Electronic communication, Mobile phone technology, Self care
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.
Interventions
DEVICETailored 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.
DEVICEPatient-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.
DEVICEPatient 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.
Sponsors
University of Maryland, Baltimore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 64 Years
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HBA1c at One Year | one year |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1: Usual Care Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG) | 56 |
| Group 2: Patient Intervention 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. | 23 |
| 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
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. | 22 |
| 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: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 | 62 |
| Total | 163 |
Baseline characteristics
| Characteristic | Group 1: Usual Care | Group 2: Patient Intervention | Group 3: Patient-physician Intervention | Group 4: Data Analyzed Intervention | Total |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 56 Participants | 23 Participants | 22 Participants | 62 Participants | 163 Participants |
| Age, Continuous | 53.2 years STANDARD_DEVIATION 8.4 | 52.8 years STANDARD_DEVIATION 8 | 53.7 years STANDARD_DEVIATION 8.2 | 52.0 years STANDARD_DEVIATION 8 | 52.8 years STANDARD_DEVIATION 8.2 |
| HbA1c | 9.2 percentage of HbA1c STANDARD_DEVIATION 1.7 | 9.3 percentage of HbA1c STANDARD_DEVIATION 1.8 | 9.0 percentage of HbA1c STANDARD_DEVIATION 1.8 | 9.9 percentage of HbA1c STANDARD_DEVIATION 2.1 | 9.4 percentage of HbA1c STANDARD_DEVIATION 2 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 27 Participants | 10 Participants | 10 Participants | 17 Participants | 64 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 1 Participants | 3 Participants | 6 Participants | 13 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 26 Participants | 12 Participants | 9 Participants | 39 Participants | 86 Participants |
| Region of Enrollment United States | 56 Participants | 23 Participants | 22 Participants | 62 Participants | 163 Participants |
| Sex: Female, Male Female | 28 Participants | 11 Participants | 10 Participants | 31 Participants | 80 Participants |
| Sex: Female, Male Male | 28 Participants | 12 Participants | 12 Participants | 31 Participants | 83 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 62 | 0 / 38 | 0 / 33 | 0 / 80 |
| other Total, other adverse events | 0 / 62 | 0 / 38 | 0 / 33 | 0 / 80 |
| serious Total, serious adverse events | 0 / 62 | 0 / 38 | 0 / 33 | 0 / 80 |
Outcome results
Primary
HBA1c at One Year
Time frame: one year
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group 1: Usual Care | HBA1c at One Year | 8.5 percentage of HbA1c | Standard Deviation 1.8 |
| Group 2: Patient Intervention | HBA1c at One Year | 7.7 percentage of HbA1c | Standard Deviation 1 |
| Group 3: Patient-physician Intervention | HBA1c at One Year | 7.9 percentage of HbA1c | Standard Deviation 1.4 |
| Group 4: Data Analyzed Intervention | HBA1c at One Year | 7.9 percentage of HbA1c | Standard Deviation 1.7 |
Comparison: 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.p-value: 0.027Mixed Models Analysis
Comparison: 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.p-value: 0.001Mixed Models Analysis