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Evaluation of a Prototype Diabetes Management System Applied to Insulin Initiation and Titration

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Massachusetts Institute of Technology
Information provided by (Responsible Party):
Joslin Diabetes Center
ClinicalTrials.gov Identifier:
NCT01698528
First received: October 1, 2012
Last updated: March 25, 2014
Last verified: March 2014

October 1, 2012
March 25, 2014
October 2012
July 2014   (final data collection date for primary outcome measure)
Glycemic control as determined by the change in absolute HbA1c level [ Time Frame: 3 months ] [ Designated as safety issue: No ]
The primary outcome of interest is absolute decrease in A1c by end of 3 months.
Same as current
Complete list of historical versions of study NCT01698528 on ClinicalTrials.gov Archive Site
  • Glycemic control as defined by reaching glycemic target of HbA1c ≤ 7% [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Secondary outcomes will include % reaching glycemic target of A1c≤7.
  • Patient Satisfaction [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    The volunteer's satisfaction with their diabetes care will be measured before and after the study
  • Frequency of hypoglycemia [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
    frequency for hypoglycemia during the study period
  • time health care providers and subjects spend on managing the insulin titration [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    time health care providers and subjects spend on managing the insulin titration through appointment, phone call, emails, faxes
Same as current
Not Provided
Not Provided
 
Evaluation of a Prototype Diabetes Management System Applied to Insulin Initiation and Titration
Evaluation of a Prototype Diabetes Management System Applied to Insulin Initiation and Titration

The purpose of this study is to determine if using a diabetes management technology system, including a tablet computer, to track diabetes care and communicate with a clinician coach (a doctor or nurse from the Joslin Clinic) makes starting and adjusting insulin easier and safer for people with type 2 diabetes. Hypothesis: The use of a diabetes management technology system with a clinician coach helps more individuals starting basal insulin achieve better glycemic control with less hypoglycemia compared with standard clinical practice at Joslin Diabetes Center.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Type II Diabetes
Device: Tablet Computer
Other Name: Toshiba tablet computer
  • Experimental: Intervention Group
    The experimental arm will be provided with a tablet computer with a newly designed software to help manage his or her diabetes care. This arm will communicate with his or her provider through the tablet computer to initiate and titrate basal insulin dose based on the 303 protocol. The individuals in this arm will also track their glucose values and medication adherence using the tablet computer by documenting when medication was taken or insulin was injected.
    Intervention: Device: Tablet Computer
  • No Intervention: Control Group
    The individuals in the control group will receive usual care from the study Clinic as they always have. These individuals will be tracking their diabetes in the same way they have been by communicating with their health care provider and his or her office via fax/phone/e-mail. These individuals will not be provided with a tablet computer.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
40
July 2015
July 2014   (final data collection date for primary outcome measure)

Inclusion:

  • 18 years or older
  • Has type 2 diabetes, starting on basal insulin therapy
  • Hemoglobin A1c between 9-14%
  • Has Wi-Fi internet connection at home
  • Is willing to monitor blood glucose at least once per day
  • Is willing to inject and self-titrate insulin dose
  • Able to read and communicate in English proficiently

Exclusion:

  • Has severe visual impairment impacting visual acuity
  • Has severe hearing impairment impacting communication
  • Has Type 1 diabetes
  • Pregnant or lactating women
  • Alcohol dependency
  • Require multiple daily insulin injections
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01698528
CHS 2012-18
Yes
Joslin Diabetes Center
Joslin Diabetes Center
Massachusetts Institute of Technology
Principal Investigator: William Hsu, M.D. Joslin Diabetes Center
Joslin Diabetes Center
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP