Mobile Diabetes Management

NCT01107015 | Completed Results DMC

• 1 other identifier: HP-00041426
• Study Type: interventional
• Target: 213
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes

Keywords

Diabetes; Glucose control; Diabetes monitoring; Care management; Electronic communication; Mobile phone technology; Self care

Outcome Measures

Primary Outcomes (1)

• HBA1c at One Year

  one year

Study Arms (4)

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

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

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

Device: Patient and PCP intervention with analyzed data

Interventions

Tailored Patient Intervention DEVICE

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.

Group 2: patient intervention

Patient-physician intervention DEVICE

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.

Group 3: patient-physician intervention

Patient and PCP intervention with analyzed data DEVICE

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.

Group 4: data analyzed intervention

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Type 2 diabetic \[patient\]
• A1c equal to or greater than 7.5 \[patient\]
• 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 \[patient\]

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

University of Maryland, Baltimore

Baltimore, Maryland, 21201, United States

Location

Related Publications (4)

• 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.

  PMID: 19250979 BACKGROUND

• Quinn 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.

  PMID: 30322839 DERIVED

• Quinn 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.

  PMID: 29396389 DERIVED

• Quinn 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.

  PMID: 29217502 DERIVED

Related Links

• 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.

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Results Point of Contact

• Title: Cindy Geppi
• Organization: University of Maryland, Baltimore

4107062406

Study Officials

• Geppi

  University of Maryland, Baltimore

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 17, 2010
• First Posted: April 20, 2010
• Study Start: June 1, 2008
• Primary Completion: August 1, 2010
• Study Completion: September 1, 2011
• Last Updated: May 31, 2023
• Results First Posted: March 1, 2018

Record last verified: 2019-12

Locations

US (1)