Evaluation of a Prototype Diabetes Management System Applied to Insulin Initiation and Titration
- Conditions
- Type II Diabetes
- Interventions
- Device: Tablet Computer
- Registration Number
- NCT01698528
- Lead Sponsor
- Joslin Diabetes Center
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group Tablet Computer 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.
- Primary Outcome Measures
Name Time Method Glycemic Control as Determined by the Change in Absolute HbA1c Level 3 months The primary outcome of interest is absolute decrease in A1c by end of 3 months.
- Secondary Outcome Measures
Name Time Method Number of Participants Reaching Target of HbA1c ≤ 7% 3 months Secondary outcomes will include % of participants reaching glycemic target of A1c≤7.
Number of Participants With Hypoglycemia 3 months Number of participants had hypoglycemia during the trial period
Time Health Care Providers and Subjects Spend on Managing the Insulin Titration 3 months time health care providers and subjects spend on managing the insulin titration through appointment, phone call, emails, faxes
Change in Average Participation Satisfaction 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, with higher scores indicating greater satisfaction. 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.
Trial Locations
- Locations (1)
Joslin Diabetes Center
🇺🇸Boston, Massachusetts, United States