DiabetesNCT01107015
Mobile Diabetes Management
A study testing Tailored Patient Intervention, Patient-physician intervention and Patient and PCP intervention with analyzed data in people with Diabetes, run by University of Maryland, Baltimore at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Diabetes
- What is being tested?
- Tailored Patient Intervention, Patient-physician intervention and Patient and PCP intervention with analyzed data
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 213 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2008to Sep 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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]
Who cannot join
- 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]
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Maryland, Baltimore
Baltimore, Maryland, 21201
About this study
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.
- Conditions
- Diabetes
- Being tested
- Tailored Patient Intervention, Patient-physician intervention, Patient and PCP intervention with analyzed data
- Keywords
- Diabetes, Glucose control, Diabetes monitoring, Care management, Electronic communication, Mobile phone technology, Self care
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tailored Patient InterventionDevice
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.
Patient-physician interventionDevice
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.
Patient and PCP intervention with analyzed dataDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Usual Care | No intervention | Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG) |
| Group 2: patient intervention | Active comparator | Home diabetes monitoring by patient using mobile phone to communicate information and receive feedback Receives: Device: Tailored Patient Intervention |
| Group 3: patient-physician intervention | Active comparator | Home diabetes monitoring by patient using mobile phone to communicate and receive feedback; Physician can access unanalyzed information from the patient's electronic logbook Receives: Device: Patient-physician intervention |
| Group 4: data analyzed intervention | Active comparator | 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 Receives: Device: Patient and PCP intervention with analyzed data |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBA1c at One Year
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2010 (estimated)
- Study startJun 2008
- Primary completionAug 2010
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 213 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Maryland, Baltimore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geppi, Study director, University of Maryland, Baltimore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01107015
- Sponsor's protocol ID
- HP-00041426
- Status last verified
- Dec 2019
- First submitted
- 17 Apr 2010
- Last updated
- 31 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Quinn CC, Gruber-Baldini AL, Shardell M, Weed K, Clough SS, Peeples M, Terrin M, Bronich-Hall L, Barr E, Lender D. Mobile diabetes intervention study: testing a personalized treatment/behavioral communication intervention for blood glucose control. Contemp Clin Trials. 2009 Jul;30(4):334-46. doi: 10.1016/j.cct.2009.02.004. Epub 2009 Feb 27.
PubMed 19250979Quinn CC, Swasey KK, Torain JM, Shardell MD, Terrin ML, Barr EA, Gruber-Baldini AL. An mHealth Diabetes Intervention for Glucose Control: Health Care Utilization Analysis. JMIR Mhealth Uhealth. 2018 Oct 15;6(10):e10776. doi: 10.2196/10776.
PubMed 30322839Quinn CC, Butler EC, Swasey KK, Shardell MD, Terrin MD, Barr EA, Gruber-Baldini AL. Mobile Diabetes Intervention Study of Patient Engagement and Impact on Blood Glucose: Mixed Methods Analysis. JMIR Mhealth Uhealth. 2018 Feb 2;6(2):e31. doi: 10.2196/mhealth.9265.
PubMed 29396389Quinn CC, Swasey KK, Crabbe JCF, Shardell MD, Terrin ML, Barr EA, Gruber-Baldini AL. The Impact of a Mobile Diabetes Health Intervention on Diabetes Distress and Depression Among Adults: Secondary Analysis of a Cluster Randomized Controlled Trial. JMIR Mhealth Uhealth. 2017 Dec 7;5(12):e183. doi: 10.2196/mhealth.8910.
PubMed 29217502
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mobile Diabetes Management
- ClinicalTrials.gov ID
- NCT01107015
- Acronym / sponsor ID
- HP-00041426
- Conditions
- Diabetes
- Keywords
- Diabetes, Glucose control, Diabetes monitoring, Care management, Electronic communication, Mobile phone technology, Self care
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 213 participants (actual)
- Lead sponsor
- University of Maryland, BaltimoreUniversity, hospital or other
- Study start
- Jun 2008
- Primary completion
- Aug 2010 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 20 Apr 2010 (estimated)
- Results
- Posted 1 Mar 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group 1: Usual Care | No intervention | –Provider-driven care, based in office, no special diabetes management; Patient self-monitoring of blood glucose (SMBG) |
| Group 2: patient intervention | Active comparator | Device: Tailored Patient InterventionHome diabetes monitoring by patient using mobile phone to communicate information and receive feedback |
| Group 3: patient-physician intervention | Active comparator | Device: Patient-physician interventionHome diabetes monitoring by patient using mobile phone to communicate and receive feedback; Physician can access unanalyzed information from the patient's electronic logbook |
| Group 4: data analyzed intervention | Active comparator | Device: Patient and PCP intervention with analyzed dataHome 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 |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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]
Key exclusion criteria (12 listed)
- 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]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tailored Patient InterventionPatients 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. | Device | Group 2: patient intervention |
| Patient-physician interventionPatients 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. | Device | Group 3: patient-physician intervention |
| Patient and PCP intervention with analyzed dataPatients 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. | Device | Group 4: data analyzed intervention |
Primary outcome
HBA1c at One Year
Time frame: one year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 19250979Quinn CC, Gruber-Baldini AL, Shardell M, Weed K, Clough SS, Peeples M, Terrin M, Bronich-Hall L, Barr E, Lender D. Mobile diabetes intervention study: testing a personalized treatment/behavioral communication intervention for blood glucose control. Contemp Clin Trials. 2009 Jul;30(4):334-46. doi: 10.1016/j.cct.2009.02.004. Epub 2009 Feb 27.
- Derived from this study: PubMed 30322839Quinn CC, Swasey KK, Torain JM, Shardell MD, Terrin ML, Barr EA, Gruber-Baldini AL. An mHealth Diabetes Intervention for Glucose Control: Health Care Utilization Analysis. JMIR Mhealth Uhealth. 2018 Oct 15;6(10):e10776. doi: 10.2196/10776.
- Derived from this study: PubMed 29396389Quinn CC, Butler EC, Swasey KK, Shardell MD, Terrin MD, Barr EA, Gruber-Baldini AL. Mobile Diabetes Intervention Study of Patient Engagement and Impact on Blood Glucose: Mixed Methods Analysis. JMIR Mhealth Uhealth. 2018 Feb 2;6(2):e31. doi: 10.2196/mhealth.9265.
- Derived from this study: PubMed 29217502Quinn CC, Swasey KK, Crabbe JCF, Shardell MD, Terrin ML, Barr EA, Gruber-Baldini AL. The Impact of a Mobile Diabetes Health Intervention on Diabetes Distress and Depression Among Adults: Secondary Analysis of a Cluster Randomized Controlled Trial. JMIR Mhealth Uhealth. 2017 Dec 7;5(12):e183. doi: 10.2196/mhealth.8910.
- Quinn CC, Shardell MD, Terrin ML, Barr EA, Ballew SH, Gruber-Baldini AL. Cluster-randomized trial of a mobile phone personalized behavioral intervention for blood glucose control.Diabetes Care. 2011 Sep;34(9):1934-42. Epub 2011 Jul 25.Link provided by the sponsor.
Related trials for Diabetes
Recruiting
Clinical Study to Evaluate the Impact of the Accu-Chek SmartGuide CGM Solution on the Mean Change in Time in Range Compared With Self-Monitoring of Blood Glucose in Participants With Type 1 and Type 2 Diabetes Mellitus
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus
Not yet recruitingPhase 2
Effects of Meal Macronutrients on Postprandial Lipids
Nephrotic Syndrome, Lipodystrophy
Enrolling by invitation
MTM2MTG Pilot Ancillary Study
Diet, Healthy, HbA1c
Active, not recruitingPhase 3
Compassionate Use of Metreleptin in Previously Treated People With Generalized Lipodystrophy
Lipodystrophy, Diabetes
Active, not recruitingPhase 2
Islet Cell Transplant for Type 1 Diabetes
Type 1 Diabetes Mellitus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geppi study director
University of Maryland, Baltimore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tailored Patient Intervention, Patient-physician intervention and Patient and PCP intervention with analyzed data in people with Diabetes, run by University of Maryland, Baltimore at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 1 Mar 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBA1c at One Year (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01107015, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2023.