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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Evaluation of a Prototype Diabetes Management System Applied to Insulin Initiation and Titration|
- 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.
- 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
|Study Start Date:||October 2012|
|Estimated Study Completion Date:||September 2013|
|Estimated Primary Completion Date:||September 2013 (Final data collection date for primary outcome measure)|
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.
|Contact: Paige E Ricci, B.Sfirstname.lastname@example.org|
|Contact: William Hsu, M.D.||email@example.com|
|United States, Massachusetts|
|Joslin Diabetes Center||Recruiting|
|Boston, Massachusetts, United States, 02215|
|Contact: Paige E Ricci, B.S 857-244-0336 firstname.lastname@example.org|
|Contact: William Hsu, M.D. 617-338-0527 email@example.com|
|Principal Investigator: William Hsu, M.D.|
|Sub-Investigator: John Moore, M.D., PhD|
|Sub-Investigator: Scott Gilroy|
|Sub-Investigator: Paige Ricci, B.S|
|Sub-Investigator: Frank Moss|
|Sub-Investigator: Sue Ghiloni, BSRN|
|Sub-Investigator: Martin Abrahamson, MD|
|Sub-Investigator: Hung Le, BS|
|Principal Investigator:||William Hsu, M.D.||Joslin Diabetes Center|