A Digital Health Tool for Insulin Titration (DHIT) Individuals With Type 2 Diabetes: A Prospective Outcomes Study With a Retrospective Control Group
- Conditions
- Diabetes Mellitus, Type 2
- Interventions
- Device: Basal Insulin Titration Application
- Registration Number
- NCT03138447
- Lead Sponsor
- Amalgam Rx, Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
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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.
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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.
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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.
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Retrospective cohort: Same as above.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Prospective Cohort Basal Insulin Titration Application -
- Primary Outcome Measures
Name Time Method Basal Insulin Dose 90 days Change in basal insulin dose from entry into study to completion of study.
- Secondary Outcome Measures
Name Time Method Participant Satisfaction 90 days Demonstration of satisfaction with the app at the completion of the study.
Change in Fasting Glucose 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 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 90 days Proportion of participants who adhered to their basal insulin dose adjustments according to their algorithm.
Change in A1C 90 days Change in hemoglobin A1C measure at the completion of the study as compared to baseline.
Change in Diabetes Distress 90 days Change in measures of diabetes distress at the completion of the study as compared to baseline.
Office Contacts 90 days Reduction in number of HCP contacts (live office visits and phone calls) regarding insulin management during 90 day period.
Trial Locations
- Locations (1)
MODEL Clinical Research
🇺🇸Towson, Maryland, United States