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

Joslin Diabetes Center

Status: Completed

Conditions: Type II Diabetes

Treatments: Device: Tablet Computer

Study type: Interventional

Funder types: Other

Identifiers

NCT01698528

CHS 2012-18

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Intervention Group

Experimental group

Description:

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.

Treatment:

Device: Tablet Computer

Control Group

No Intervention group

Description:

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.