Back to resultsA Digital Health Tool for Insulin Titration (DHIT) Individuals With Type 2 Diabetes: A Prospective Outcomes Study With a Retrospective Control Group (DHIT)
Primary Purpose
Diabetes Mellitus, Type 2
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Basal Insulin Titration Application
Sponsored by
About this trial
This is an interventional treatment trial for Diabetes Mellitus, Type 2 focused on measuring insulin, basal, titration, digital health
Eligibility Criteria
Inclusion Criteria:
- Prospective cohort: The participants will be patients with type 2 diabetes mellitus who are not at goal on their current dose of prescribed basal insulin (e.g. Lantus, Toujeo, Levemir, Tresiba, or Basaglar). Participants shall be age 21 or older, prescribed basal insulin within the past 18 months, own a compatible mobile phone, able to receive/make calls and read messages on their phone. There is no predefined gender or ethnic group. Participants should be generally healthy and not expected to be hospitalized for surgery or other medical care during the study period.
- Retrospective cohort: This will be a chart review. Participants will be matched to the prospective cohort for age, gender and baseline A1C. Patients should have been prescribed one of the basal insulins above.
Exclusion Criteria:
- Prospective cohort: Participants with stage 4 or 5 kidney disease, active malignancies, variable glucocorticoid doses during the study period, severe visual impairment, or dementia will be excluded. Also, participants prescribed rapid-acting or premixed insulins (any insulin not on the above list) will be excluded.
- Retrospective cohort: Same as above.
Sites / Locations
- MODEL Clinical Research
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Prospective Cohort
Retrospective Cohort
Arm Description
Outcomes
Primary Outcome Measures
Basal Insulin Dose
Change in basal insulin dose from entry into study to completion of study.
Secondary Outcome Measures
Change in Fasting Glucose
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
Proportion of participants whose fasting blood glucose is in the ADA target range by the end of the 90 day study period.
Titration Adherence
Proportion of participants who adhered to their basal insulin dose adjustments according to their algorithm.
Change in A1C
Change in hemoglobin A1C measure at the completion of the study as compared to baseline.
Change in Diabetes Distress
Change in measures of diabetes distress at the completion of the study as compared to baseline.
Participant Satisfaction
Demonstration of satisfaction with the app at the completion of the study.
Office Contacts
Reduction in number of HCP contacts (live office visits and phone calls) regarding insulin management during 90 day period.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03138447
Brief Title
A Digital Health Tool for Insulin Titration (DHIT) Individuals With Type 2 Diabetes: A Prospective Outcomes Study With a Retrospective Control Group
Acronym
DHIT
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.
Study Type
Interventional
2. Study Status
Record Verification Date
March 2019
Overall Recruitment Status
Completed
Study Start Date
March 30, 2017 (Actual)
Primary Completion Date
January 30, 2019 (Actual)
Study Completion Date
January 30, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Amalgam Rx, Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The digital health tool is an application ("app") available on iOS and Android enabled mobile phones. Health Care Providers ("HCPs") configure algorithms which can be tailored to individual patient's needs and then prescribe the app to support optimal basal insulin titration and dosing. In this study, participants will be recruited from a medical practice in which an HCP has prescribed a once-daily basal insulin. Participants will be trained on the use of the app utilizing their own mobile phone. During training, a brief self-assessment survey will be administered. After 90 days of usage, a telephone survey will be conducted. The baseline A1C results and the end of study A1C results will be collected from the patients' routine clinical care records. Data from the retrospective control group will be collected from a chart review of the same practice.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetes Mellitus, Type 2
Keywords
insulin, basal, titration, digital health
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Non-Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Prospective Cohort
Arm Type
Experimental
Arm Title
Retrospective Cohort
Arm Type
No Intervention
Intervention Type
Device
Intervention Name(s)
Basal Insulin Titration Application
Intervention Description
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.
Primary Outcome Measure Information:
Title
Basal Insulin Dose
Description
Change in basal insulin dose from entry into study to completion of study.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Change in Fasting Glucose
Description
Change in the average fasting blood glucose in the final week of the study as compared to the first week of the study.
Time Frame
90 days
Title
Fasting Glucose in Target
Description
Proportion of participants whose fasting blood glucose is in the ADA target range by the end of the 90 day study period.
Time Frame
90 days
Title
Titration Adherence
Description
Proportion of participants who adhered to their basal insulin dose adjustments according to their algorithm.
Time Frame
90 days
Title
Change in A1C
Description
Change in hemoglobin A1C measure at the completion of the study as compared to baseline.
Time Frame
90 days
Title
Change in Diabetes Distress
Description
Change in measures of diabetes distress at the completion of the study as compared to baseline.
Time Frame
90 days
Title
Participant Satisfaction
Description
Demonstration of satisfaction with the app at the completion of the study.
Time Frame
90 days
Title
Office Contacts
Description
Reduction in number of HCP contacts (live office visits and phone calls) regarding insulin management during 90 day period.
Time Frame
90 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
- Prospective cohort: The participants will be patients with type 2 diabetes mellitus who are not at goal on their current dose of prescribed basal insulin (e.g. Lantus, Toujeo, Levemir, Tresiba, or Basaglar). Participants shall be age 21 or older, prescribed basal insulin within the past 18 months, own a compatible mobile phone, able to receive/make calls and read messages on their phone. There is no predefined gender or ethnic group. Participants should be generally healthy and not expected to be hospitalized for surgery or other medical care during the study period.
- Retrospective cohort: This will be a chart review. Participants will be matched to the prospective cohort for age, gender and baseline A1C. Patients should have been prescribed one of the basal insulins above.
Exclusion Criteria:
- Prospective cohort: Participants with stage 4 or 5 kidney disease, active malignancies, variable glucocorticoid doses during the study period, severe visual impairment, or dementia will be excluded. Also, participants prescribed rapid-acting or premixed insulins (any insulin not on the above list) will be excluded.
- Retrospective cohort: Same as above.
Facility Information:
Facility Name
MODEL Clinical Research
City
Towson
State/Province
Maryland
ZIP/Postal Code
21204
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Digital Health Tool for Insulin Titration (DHIT) Individuals With Type 2 Diabetes: A Prospective Outcomes Study With a Retrospective Control Group
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