Diabetes Mellitus, Type 2
Conditions
Keywords
Diabetes, Insulin, Progression, Patient Reported Measures, Adherence, Heterogeneity, Hypoglycemia
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.
Interventions
None listed
Sponsors
Eli Lilly and Company
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Insulin-Related Treatment Change From Initial Insulin Therapy | Baseline through 24 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Hypoglycemic and Severe Hypoglycemic Episodes | Baseline through 24 months | 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. |
| Number of Participants Adherent to Prescribed Insulin Therapy During the Study (Study Adherent) | Baseline through 24 months | 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. |
| Number of Participants Who Achieved Their Personalized HbA1c Target by the End of the Study | Baseline through 24 months | 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. |
Countries
Argentina, Brazil, Canada, China, Germany, India, Israel, Italy, Japan, Mexico, Puerto Rico, Russia, Saudi Arabia, South Korea, Spain, Turkey (Türkiye), United Arab Emirates, United Kingdom, United States
Participant flow
Pre-assignment details
Participants who had complete treatment data are participants with complete insulin, oral antidiabetic medication (OAM), and glucagon-like peptide (GLP) data at all 5 visits.
Participants by arm
| Arm | Count |
|---|---|
| MOSAIc Participants Participants enrolled in MOSAIc who had complete treatment data during the study. | 2,528 |
| Total | 2,528 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Death | 82 |
| Overall Study | Lost to Follow-up | 196 |
| Overall Study | Lost to follow up + Subject Decision | 2 |
| Overall Study | Other | 422 |
| Overall Study | Physician Decision | 57 |
| Overall Study | Withdrawal by Subject | 158 |
Baseline characteristics
| Characteristic | MOSAIc Participants |
|---|---|
| Age, Continuous | 61 years STANDARD_DEVIATION 10.8 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 497 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1133 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 898 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 35 Participants |
| Race (NIH/OMB) Asian | 1029 Participants |
| Race (NIH/OMB) Black or African American | 71 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 78 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 43 Participants |
| Race (NIH/OMB) White | 1272 Participants |
| Region of Enrollment Argentina | 101 Participants |
| Region of Enrollment Brazil | 78 Participants |
| Region of Enrollment Canada | 107 Participants |
| Region of Enrollment China | 225 Participants |
| Region of Enrollment Germany | 101 Participants |
| Region of Enrollment India | 631 Participants |
| Region of Enrollment Israel | 36 Participants |
| Region of Enrollment Italy | 77 Participants |
| Region of Enrollment Japan | 99 Participants |
| Region of Enrollment Mexico | 126 Participants |
| Region of Enrollment Puerto Rico | 96 Participants |
| Region of Enrollment Russia | 158 Participants |
| Region of Enrollment Saudi Arabia | 148 Participants |
| Region of Enrollment South Korea | 83 Participants |
| Region of Enrollment Spain | 108 Participants |
| Region of Enrollment Turkey | 100 Participants |
| Region of Enrollment United Arab Emirates | 48 Participants |
| Region of Enrollment United Kingdom | 24 Participants |
| Region of Enrollment United States | 182 Participants |
| Sex: Female, Male Female | 1270 Participants |
| Sex: Female, Male Male | 1258 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 82 / 4,299 |
| other Total, other adverse events | 1,199 / 2,528 |
| serious Total, serious adverse events | 130 / 2,528 |
Outcome results
Primary
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.
Time frame: Baseline through 24 months
Population: All participants enrolled in MOSAIc who had complete treatment data during the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MOSAIc Participants | Number of Participants With Insulin-Related Treatment Change From Initial Insulin Therapy | 2171 Participants |
Comparison: Public insurance95% CI: [0.54, 0.92]
Comparison: Diabetes support service available95% CI: [1.5, 2.46]
Comparison: Baseline HbA1c \> 7.80 (reference:HbA1c≤7.80 median)95% CI: [1.38, 2.49]
Comparison: Baseline HbA1c missing (reference:HbA1c≤7.80 median)95% CI: [1.15, 2.07]
Comparison: Diabetes duration \> 11 years95% CI: [1.13, 1.88]
Comparison: Age (per year increase)95% CI: [0.97, 1]
Comparison: Baseline insulin therapy: combination95% CI: [3.3, 33.41]
Comparison: Baseline insulin therapy: prandial only95% CI: [1.77, 18.37]
Comparison: Baseline insulin therapy: pre-mixed only95% CI: [3.02, 5.73]
Comparison: Discrimination domain of the IPC95% CI: [0.39, 0.65]
Comparison: Diabetes Distress Scale total score \> 295% CI: [0.57, 0.95]
Secondary
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.
Time frame: Baseline through 24 months
Population: All participants enrolled in MOSAIc who had complete treatment data during the study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| MOSAIc Participants | Number of Hypoglycemic and Severe Hypoglycemic Episodes | Total hypoglycemic episodes during study | 7950 episodes |
| MOSAIc Participants | Number of Hypoglycemic and Severe Hypoglycemic Episodes | Total severe hypoglycemic episodes during study | 225 episodes |
Secondary
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.
Time frame: Baseline through 24 months
Population: All participants enrolled in MOSAIc who had complete treatment data during the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MOSAIc Participants | Number of Participants Adherent to Prescribed Insulin Therapy During the Study (Study Adherent) | 2446 Participants |
Secondary
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.
Time frame: Baseline through 24 months
Population: All participants enrolled in MOSAIc who had complete treatment data during the study.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| MOSAIc Participants | Number of Participants Who Achieved Their Personalized HbA1c Target by the End of the Study | 392 Participants |