An Observational Study to Understand Challenges Associated With Progression of Insulin Therapy in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify specific patient, physician, and health system related factors associated with the progression to a more intensive regimen from initial insulin therapy for patients with type 2 diabetes.

Official Title
-----------------
A Multinational Observational Study Assessing Insulin Use: Understanding the Challenges Associated With Progression of Therapy - The MOSAIc Type 2 Diabetes Study

Conditions
-----------------
Diabetes Mellitus, Type 2

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have been diagnosed with type 2 diabetes Have presented within the normal course of care Have been on their initial insulin therapy for ≥3 months (with or without any combination of approved non-insulin anti-diabetic medications) Are not simultaneously participating in a study that includes an investigational drug or procedure at entry into the study Have been fully informed and have given written consent for the use of their data Have a sufficient understanding of the primary language of the country such that they will be able to complete the questionnaires Have not initiated basal bolus therapy (three mealtime insulin injections) Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MOSAIc Participants<br>Participants enrolled in Multinational Observational Study Assessing Insulin use (MOSAIc) who had complete treatment data during the study. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Insulin-Related Treatment Change From Initial Insulin Therapy | Multivariable logistic regression model examined baseline participant-, physician-, and healthcare system-related factors associated with the occurrence of any change in insulin therapy. Discrimination domain of the Interpersonal Processes of Care Survey [IPC] ranges from 1-5 with higher scores indicating more discrimination and Diabetes Distress Scale ranges from 1-6 with higher scores indicating more distress. | Baseline through 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Hypoglycemic and Severe Hypoglycemic Episodes | Hypoglycemia and severe hypoglycemia episodes are self-reported by all participants with complete treatment data from one month prior to the baseline visit until the last visit (24 months). Patients were asked at each visit to self-report any hypoglycemia since their last visit. At the baseline visit participants were asked their hypoglycemia information for the month prior to the baseline visit. | Baseline through 24 months | 
| Number of Participants Adherent to Prescribed Insulin Therapy During the Study (Study Adherent) | MOSAIC participants answered the question: How often did you miss your insulin shots during the last 7 days?. At each visit, participants were defined as visit adherent if the participant answered I did not miss any shots or I missed some of my shots. They were defined as not visit adherent if he/she answered any of the following: I missed about half of my shots, I missed most of my shots, or I missed all of my shots. A participant is defined to be study adherent if at least: 4 out of 5 visit adherent. | Baseline through 24 months | 
| Number of Participants Who Achieved Their Personalized HbA1c Target by the End of the Study | As diabetes management practices vary across the countries represented in MOSAIC, a more apt measure of reaching goal is the personalized target that was set for each patient at the beginning of the study. | Baseline through 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes, Insulin, Progression, Patient Reported Measures, Adherence, Heterogeneity, Hypoglycemia