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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03138447
Recruitment Status : Recruiting
First Posted : May 3, 2017
Last Update Posted : May 3, 2017
Information provided by (Responsible Party):
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.

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
Allocation: Non-Randomized
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)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Basal Insulin Dose [ Time Frame: 90 days ]
    Change in basal insulin dose from entry into study to completion of study.

Secondary Outcome Measures :
  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.

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT03138447

United States, Maryland
MODEL Clinical Research Recruiting
Towson, Maryland, United States, 21204
Contact: Karen Klein    443-524-1789   
Principal Investigator: Philip A Levin, MD         
Sponsors and Collaborators
Amalgam Rx, Inc.

Responsible Party: Amalgam Rx, Inc. Identifier: NCT03138447     History of Changes
Other Study ID Numbers: IS001
First Posted: May 3, 2017    Key Record Dates
Last Update Posted: May 3, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Amalgam Rx, Inc.:
digital health

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Hypoglycemic Agents
Physiological Effects of Drugs