Clinical trial NCT01107015: Mobile Diabetes Management
Official title: Mobile Diabetes Management
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes
Keywords: Diabetes
Glucose control
Diabetes monitoring
Care management
Electronic communication
Mobile phone technology
Self care
Lead sponsor: University of Maryland, Baltimore
Sponsor class: OTHER
First posted: 2010-04-20
Enrollment: 213
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: HBA1c at One Year
timeFrame: one year
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: University of Maryland, Baltimore
state: Maryland
Study officials:
affiliation: University of Maryland, Baltimore
name: Geppi
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.