My Dose Coach Mobile App to Support Insulin Titration and Maintenance

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-02-15

Study Completion Date

2023-02-16

Brief Summary

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The purpose of this research study is to evaluate an electronic application (app) designed to help people with type 2 diabetes (T2DM) adjust their insulin doses. The app is called My Dose Coach. This research study is being done in 2 phases. Specifically in Phase 1, the study is assessing the role of the My Dose Coach app in helping participants make insulin adjustments to get their blood glucoses to the target level that is planned for with the diabetes team, called the dosing or titration phase, when first starting insulin. In Phase 2, the study is assessing the role of the My Dose Coach app in helping participants keep blood glucoses in the target range, called the maintenance phase.

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Detailed Description

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Despite the increasing body of knowledge of diabetes treatment strategies, a majority of patients with T2DM are still in a persistent state of poor glycemic control and unable to meet target goals. Inertia surrounding insulin initiation and titration is a specific problem. Various approaches have been proposed to help overcome clinical inertia, including support of patient self-management, and education for both physicians and people with diabetes. Presently, paper-based guides are available in which clinicians/educators rely on to help their patients in determining and recording appropriate insulin doses. Unfortunately, this process often sets the stage for reluctance and fear of insulin initiation and delays titration with implications for long-term poor self-management and adherence. Therefore, Sanofi developed the My Dose Coach electronic app to assist with optimizing titration of basal insulins and supporting proper insulin maintenance. The primary objective of this two phase study is to demonstrate that patients who are trained on the My Dose Coach app to titrate insulin will have greater improvements in hemoglobin A1c and will be more likely to achieve glycemic control at three months as compared to usual care practice, and, for the intervention group only, those who do attain glycemic goals will be able to maintain glycemic control for an additional three months. The secondary objective of this study is to examine the feasibility of integrating digital solutions into clinical workflow and user acceptability of My Dose Coach.

Conditions

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Diabetes Mellitus Type 2 - Insulin-Treated

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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My Dose Coach (Insulin Dosing Support App)

Phase 1 Titration: Patients receive insulin therapy education from diabetes educator (DE). Plus, DE trains patients to use My Dose Coach (MDC) for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients are asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reach glycemic target are invited to Phase 2. Other patients are invited to continue titrating for another 3 months.

Phase 2 Maintenance: At 3-mo clinic visit, an EP or DE trains patients the MDC Maintenance Module to support proper insulin dosing. Patients are asked to return for follow-up clinic visits at mo 6.

Patients are surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability.

Group Type EXPERIMENTAL

Smartphone application and web portal

Intervention Type DEVICE

My Dose Coach is indicated for single patient use outside the clinic setting by a previously diagnosed Type 2 Diabetic who has been prescribed a once-daily long-acting basal insulin. MDC is intended as an aid to the patient to provide dose suggestions based upon the HCP's independent professional judgment. Before My Dose Coach can be used, the HCP configures the dose instructions for the specific patient and activates the application using the specific patient Instructions. The application uses the dose plan instructions provided by the patient's HCP to provide dose suggestions of once-daily long-acting basal insulin (i.e. basal insulin titration) that are based on the patient's Fasting Blood Glucose (FBG) as well as hypoglycemia occurrence.

MDC includes a Maintenance Module designed to support patients in maintaining proper insulin dosingby enabling logging of administered doses of prescribed diabetes medications and BGM and providing dosing and measurement reminders.

Standard Insulin Therapy Education

Intervention Type BEHAVIORAL

Standard best practices for training patients to administer insulin therapy include 1) a thorough patient assessment prior to therapy initiation to address barriers, including evaluation for diminished cognitive capacity or other problem that may impair safe insulin self-administration, and assessment of health literacy and numeracy skills; 2) observation of a patient's injection practice, with re-education provided as needed; 3) use of appropriate language is necessary when teaching injection technique; 4) dose preparation, which includes inspecting the insulin dose for accuracy (following manufacturer instructions); and 5) review of signs, symptoms and treatment of hypoglycemia must be included as a critical component of the training.

Usual Care Group

A retrospective comparative group will be selected from eligible patients who previously were treated at the University of Pittsburgh Medical Center (UPMC) Diabetes Outpatient Clinics following standard insulin therapy education. Patients in the usual care group will be identified using data available in the electronic medical record system. Propensity score matching will be used to pair intervention and usual care participants during phase 1 of the study (baseline to 3 months).

Group Type ACTIVE_COMPARATOR

Standard Insulin Therapy Education

Intervention Type BEHAVIORAL

Standard best practices for training patients to administer insulin therapy include 1) a thorough patient assessment prior to therapy initiation to address barriers, including evaluation for diminished cognitive capacity or other problem that may impair safe insulin self-administration, and assessment of health literacy and numeracy skills; 2) observation of a patient's injection practice, with re-education provided as needed; 3) use of appropriate language is necessary when teaching injection technique; 4) dose preparation, which includes inspecting the insulin dose for accuracy (following manufacturer instructions); and 5) review of signs, symptoms and treatment of hypoglycemia must be included as a critical component of the training.

Interventions

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Smartphone application and web portal

My Dose Coach is indicated for single patient use outside the clinic setting by a previously diagnosed Type 2 Diabetic who has been prescribed a once-daily long-acting basal insulin. MDC is intended as an aid to the patient to provide dose suggestions based upon the HCP's independent professional judgment. Before My Dose Coach can be used, the HCP configures the dose instructions for the specific patient and activates the application using the specific patient Instructions. The application uses the dose plan instructions provided by the patient's HCP to provide dose suggestions of once-daily long-acting basal insulin (i.e. basal insulin titration) that are based on the patient's Fasting Blood Glucose (FBG) as well as hypoglycemia occurrence.

MDC includes a Maintenance Module designed to support patients in maintaining proper insulin dosingby enabling logging of administered doses of prescribed diabetes medications and BGM and providing dosing and measurement reminders.

Intervention Type DEVICE

Standard Insulin Therapy Education

Standard best practices for training patients to administer insulin therapy include 1) a thorough patient assessment prior to therapy initiation to address barriers, including evaluation for diminished cognitive capacity or other problem that may impair safe insulin self-administration, and assessment of health literacy and numeracy skills; 2) observation of a patient's injection practice, with re-education provided as needed; 3) use of appropriate language is necessary when teaching injection technique; 4) dose preparation, which includes inspecting the insulin dose for accuracy (following manufacturer instructions); and 5) review of signs, symptoms and treatment of hypoglycemia must be included as a critical component of the training.

Intervention Type BEHAVIORAL

Other Intervention Names

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My Dose Coach

Eligibility Criteria

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Inclusion Criteria

Intervention Group

* Patient receiving care at a UPMC Diabetes Outpatient and/or Inpatient settings
* Adult male and female patients 18 to 75 years old
* HbA1c \> 7.5%
* Recommended to start self titration of basal insulin
* Access to and able to use an iOS (Apple phone operating system) or Android enabled device and have reliable internet access
* Willing and able to use the MDC app
* Able to comprehend basic diabetes survival skills, signs and symptoms of hypoglycemia and treatment of BG

Usual Care Group

* Adult male and female patients 18 to 75 years old
* HbA1c \> 7.5%
* Started on basal insulin in a UPMC Diabetes Outpatient facility within the past three years of study start
* Has blood glucose data available in electronic medical records (EMR) (At least two HbA1c measurements corresponding to baseline and a subsequent time point after insulin titration)