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NCT Number: NCT03138447

A Digital Health Tool for Insulin Titration (DHIT) Individuals With Type 2 Diabetes: A Prospective Outcomes Study With a Retrospective Control Group

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.

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Key information

Conditions

Diabetes Mellitus, Type 2 Diabetes Mellitus Endocrine System Diseases Glucose Metabolism Disorders Hyperinsulinism Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

MODEL Clinical Research

Towson, Maryland, 21204, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Basal Insulin Titration Application

Device

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 outcomes

  1. Basal Insulin Dose

    Time frame: 90 days

    Change in basal insulin dose from entry into study to completion of study.

Secondary outcomes

  1. 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.

  2. 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.

  3. Titration Adherence

    Time frame: 90 days

    Proportion of participants who adhered to their basal insulin dose adjustments according to their algorithm.

  4. Change in A1C

    Time frame: 90 days

    Change in hemoglobin A1C measure at the completion of the study as compared to baseline.

  5. Change in Diabetes Distress

    Time frame: 90 days

    Change in measures of diabetes distress at the completion of the study as compared to baseline.

  6. Participant Satisfaction

    Time frame: 90 days

    Demonstration of satisfaction with the app at the completion of the study.

  7. 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.

Sponsors and collaborators

Lead sponsor

Amalgam Rx, Inc.

Industry

Registry information

Official study title

A Digital Health Tool for Insulin Titration (DHIT) for Individuals With Type 2 Diabetes: A Prospective Outcomes Study With a Retrospective Control Group.

Acronym: DHIT

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
May 3, 2017
Registry last updated
Mar 13, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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