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
|Condition or disease||Intervention/treatment||Phase|
|Type II Diabetes||Device: Tablet Computer||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Evaluation of a Prototype Diabetes Management System Applied to Insulin Initiation and Titration|
|Study Start Date :||October 2012|
|Actual Primary Completion Date :||October 2015|
|Actual Study Completion Date :||October 2015|
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.
Device: Tablet Computer
Other Name: Toshiba 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.
- 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.
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01698528
|United States, Massachusetts|
|Joslin Diabetes Center|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||William Hsu, M.D.||Joslin Diabetes Center|