mHealth Titration and Management
|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. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03908762|
Recruitment Status : Unknown
Verified April 2019 by Amalgam Rx, Inc..
Recruitment status was: Recruiting
First Posted : April 9, 2019
Last Update Posted : April 9, 2019
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus, Type 2 Diabetic Complication||Device: iSage App with connected glucometer Behavioral: Magnet||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of a Digital Therapeutic and Connected Devices to Support Insulin Titration|
|Actual Study Start Date :||January 1, 2019|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||March 2020|
The provider will choose a treatment algorithm embedded within the app and set the parameters to make insulin dose adjustments no less frequently than every 7 days. The app is downloaded by the patient while in the examination room, and the patient is instructed to perform daily fasting glucose fingerstick measurements and follow the app's recommendations for insulin adjustment. Data on telephone or visit contact with a healthcare provider will be collected via the EMR. Hypoglycemic events (defined as blood glucose <70 mg/dl, measured or perceived) are recorded in the iSage application as well as patient report. Providers are asked to review the patients transmitted blood sugar logs as necessary, and those reviews are recorded. Return visits are managed by the HCP and will be logged as resource utilization.
Device: iSage App with connected glucometer
Providers prescribe an insulin dosing plan to patients and provide them with a connected glucometer. The patient's plan is administered through a mobile application. In addition, patients receive education and guidance on insulin administration.
Active Comparator: Conventional Management
Our clinic uses a modified treat-to-target algorithm which is summarized on a 3 x 5 refrigerator magnet. In the case of glargine or detemir (Basaglar, Lantus, Levemir) adjustments of 1 unit of insulin/day are made until the fasting blood sugars (2 of 3 consecutive values) are 80-130 mg/dl. In the instance of Toujeo or Tresiba, adjustments of 2 units are made every 5 days. Volunteers will have meters downloaded (or interviewed where necessary) to obtain data on fasting blood sugar and episodes of hypoglycemia (perceived or measured <70 mg/dl). The PCP is free to request glucose logs and set return appointments as needed to manage the patient.
Patients are given a refrigerator magnet with an insulin titration algorithm and are asked to follow the instructions on the magnet.
- Change in A1C [ Time Frame: 3 Months ]Mean and Median Change from Baseline
- A1C in Target [ Time Frame: Baseline to 3 months ]Percentage of patients with an A1C < 7
- Rate of Hypoglycemia [ Time Frame: Baseline to 3 months ]Percentage of glucose readings <70
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): NCT03908762
|United States, Kansas|
|Cray Diabetes Self-Management Center||Recruiting|
|Kansas City, Kansas, United States, 66160|
|Contact: Teri Lavenbarg 913-588-6022 firstname.lastname@example.org|
|Principal Investigator: David Robbins|
|Sub-Investigator: Kristin Grdinovac|