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

Type II Diabetes Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01698528
• Other study ID #: CHS 2012-18
• Status: Completed
• Phase: N/A
• Start date: October 2012
• Est. completion date: October 2015

Study information

• Verified date: September 2018
• Source: Joslin Diabetes Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type II Diabetes

Intervention

Device:
• Tablet Computer

Locations

Country	Name	City	State
United States	Joslin Diabetes Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Joslin Diabetes Center	Massachusetts Institute of Technology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Glycemic Control as Determined by the Change in Absolute HbA1c Level	The primary outcome of interest is absolute decrease in A1c by end of 3 months.	3 months
Secondary	Number of Participants Reaching Target of HbA1c = 7%	Secondary outcomes will include % of participants reaching glycemic target of A1c=7.	3 months
Secondary	Change in Average Participation Satisfaction	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.	3 months
Secondary	Number of Participants With Hypoglycemia	Number of participants had hypoglycemia during the trial period	3 months
Secondary	Time Health Care Providers and Subjects Spend on Managing the Insulin Titration	time health care providers and subjects spend on managing the insulin titration through appointment, phone call, emails, faxes	3 months