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

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ClinicalTrials.gov Identifier: NCT01698528
Recruitment Status : Completed
First Posted : October 3, 2012
Results First Posted : September 14, 2017
Last Update Posted : September 14, 2017
Sponsor:
Collaborator:
Information provided by (Responsible Party):

October 1, 2012
October 3, 2012
April 20, 2017
September 14, 2017
September 14, 2017
October 2012
October 2015   (Final data collection date for primary outcome measure)
Glycemic Control as Determined by the Change in Absolute HbA1c Level [ Time Frame: 3 months ]
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
  • Number of Participants Reaching Target of HbA1c ≤ 7% [ Time Frame: 3 months ]
    Secondary outcomes will include % of participants reaching glycemic target of A1c≤7.
  • Change in Average Participation Satisfaction [ Time Frame: 3 months ]
    The volunteer's satisfaction with their diabetes care will be measured at the beginning and at the end of the study. Diabetes Treatment Satisfaction Questionnaire (DTSQ) was used for assessing the satisfactory level. DTSQ consisted of 8 questions, each question with a score scale of 0-6 (very dissatisfied to very satisfied), leading to a final score range of 0-48. The change in the DTSQ comparing before (time 0) and end of the study (t=3months) was measured. The average change in the intervention group and control group were listed in the outcome measure data table.
  • Number of Participants With Hypoglycemia [ Time Frame: 3 months ]
    Number of participants had hypoglycemia during the trial period
  • Time Health Care Providers and Subjects Spend on Managing the Insulin Titration [ Time Frame: 3 months ]
    time health care providers and subjects spend on managing the insulin titration through appointment, phone call, emails, faxes
  • Glycemic control as defined by reaching glycemic target of HbA1c ≤ 7% [ Time Frame: 3 months ]
    Secondary outcomes will include % reaching glycemic target of A1c≤7.
  • Patient Satisfaction [ Time Frame: 3 months ]
    The volunteer's satisfaction with their diabetes care will be measured before and after the study
  • Frequency of hypoglycemia [ Time Frame: 3 months ]
    frequency for hypoglycemia during the study period
  • Time Health Care Providers and Subjects Spend on Managing the Insulin Titration [ Time Frame: 3 months ]
    time health care providers and subjects spend on managing the insulin titration through appointment, phone call, emails, faxes
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
Intervention Model: Parallel Assignment
Masking: None (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.
 
Completed
40
October 2015
October 2015   (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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01698528
CHS 2012-18
Yes
Not Provided
Not Provided
Joslin Diabetes Center
Joslin Diabetes Center
Massachusetts Institute of Technology
Principal Investigator: William Hsu, M.D. Joslin Diabetes Center
Joslin Diabetes Center
August 2017

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