A Digital Health Tool for Insulin Titration (DHIT) Individuals With Type 2 Diabetes: A Prospective Outcomes Study With a Retrospective Control Group (DHIT)
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|ClinicalTrials.gov Identifier: NCT03138447|
Recruitment Status : Recruiting
First Posted : May 3, 2017
Last Update Posted : May 3, 2017
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2||Device: Basal Insulin Titration Application||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||The design of this protocol involves a prospective and retrospective cohort. The prospective cohort includes 30 participants. In the retrospective chart review, participants will be matched to the prospective group for age, gender, and baseline A1C. (For this study, the use of the word 'matched' means that the retrospective patient charts will be matched as close as possible from available patient data within the Bay West Endocrinology medical record database and may not always be an exact match to the prospective group for age, gender, and baseline A1c.) The chart review will thus be conducted after the last subject is enrolled in the prospective arm of the study.|
|Masking:||None (Open Label)|
|Official Title:||A Digital Health Tool for Insulin Titration (DHIT) for Individuals With Type 2 Diabetes: A Prospective Outcomes Study With a Retrospective Control Group.|
|Actual Study Start Date :||March 30, 2017|
|Estimated Primary Completion Date :||September 2017|
|Estimated Study Completion Date :||November 2017|
|Experimental: Prospective Cohort||
Device: Basal Insulin Titration Application
Healthcare Providers ("HCP") and the principal investigator ("PI") will use an HCP portal to initiate a basal insulin titration algorithm. HCPs can customize the titration algorithm for every participant. Once a participant is prescribed an algorithm, they can download a mobile app on their phone with their HCPs corresponding titration plan. The app will prompt participants to enter their fasting glucose daily. Based on their fasting glucose and their HCPs titration plan, the application will display the participants daily basal insulin dose.
|No Intervention: Retrospective Cohort|
- Basal Insulin Dose [ Time Frame: 90 days ]Change in basal insulin dose from entry into study to completion of study.
- Change in Fasting Glucose [ Time Frame: 90 days ]Change in the average fasting blood glucose in the final week of the study as compared to the first week of the study.
- Fasting Glucose in Target [ Time Frame: 90 days ]Proportion of participants whose fasting blood glucose is in the ADA target range by the end of the 90 day study period.
- Titration Adherence [ Time Frame: 90 days ]Proportion of participants who adhered to their basal insulin dose adjustments according to their algorithm.
- Change in A1C [ Time Frame: 90 days ]Change in hemoglobin A1C measure at the completion of the study as compared to baseline.
- Change in Diabetes Distress [ Time Frame: 90 days ]Change in measures of diabetes distress at the completion of the study as compared to baseline.
- Participant Satisfaction [ Time Frame: 90 days ]Demonstration of satisfaction with the app at the completion of the study.
- Office Contacts [ Time Frame: 90 days ]Reduction in number of HCP contacts (live office visits and phone calls) regarding insulin management during 90 day period.
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): NCT03138447
|United States, Maryland|
|MODEL Clinical Research||Recruiting|
|Towson, Maryland, United States, 21204|
|Contact: Karen Klein 443-524-1789 firstname.lastname@example.org|
|Principal Investigator: Philip A Levin, MD|