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Technical issues with app and prolonged recruitment
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| Name | Class |
|---|---|
| Sanofi | INDUSTRY |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| My Dose Coach (Insulin Dosing Support App) | Experimental | 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. |
|
| Usual Care Group | Active Comparator | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smartphone application and web portal | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Glycemic Control at 3 Months | Average change in hemoglobin A1c from baseline to 3 months | Baseline to 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Fasting Blood Glucose at 3 Months | Change in fasting blood glucose from baseline to 3 months for the intervention group. | Baseline to 3 months |
| Change From Baseline in Fasting Blood Glucose at 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Participant Use of My Dose Coach | Patient use of My Dose Coach app was track through the app's data analytics software platform. High app use was defined as logging in app >3days per week. | As reported across study period, up to 6 months |
| Number of Technical Complaints |
Inclusion Criteria:
Intervention Group
Usual Care Group
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Linda Siminerio, RN, PhD, CDE | Professor | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 15735199 | Result | Polonsky WH, Fisher L, Earles J, Dudl RJ, Lees J, Mullan J, Jackson RA. Assessing psychosocial distress in diabetes: development of the diabetes distress scale. Diabetes Care. 2005 Mar;28(3):626-31. doi: 10.2337/diacare.28.3.626. | |
| 22228744 | Result | Fisher L, Hessler DM, Polonsky WH, Mullan J. When is diabetes distress clinically meaningful?: establishing cut points for the Diabetes Distress Scale. Diabetes Care. 2012 Feb;35(2):259-64. doi: 10.2337/dc11-1572. Epub 2012 Jan 6. |
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A consent form used in enrolling participants will be posted.
After the clinical trial is closed to recruitment, and no later than 60 days after the last study visit by any subject, as required by the protocol.
ICF will be added to Clinicaltrials.gov record.
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Usual care is a historical comparison group, therefore usual care participants were not considered to be enrolled into the study.
Participants were identified at participating community-based primary care practices, diabetes outpatient clinics and hospital inpatient units.
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| ID | Title | Description |
|---|---|---|
| FG000 | My Dose Coach (Insulin Dosing Support App) | Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo. Phase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo. Patients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability. |
| FG001 | Usual Care Group | A retrospective comparative group was 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 were identified using data available in the electronic medical record system. Propensity score matching were used to pair intervention and usual care participants. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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|
Usual care participants were identified through retrospective chart review; they were not formally enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| BG000 | Intervention | Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo. Phase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo. Patients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Glycemic Control at 3 Months | Average change in hemoglobin A1c from baseline to 3 months | Using propensity score matching, 33 intervention participants were paired with 33 usual care participants to compare changes in hemoglobin A1c from baseline to 3 months. | Posted | Mean | Standard Deviation | % glycated hemoglobin | Baseline to 3 months |
|
6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Intervention | Phase 1 Titration: Patients received insulin therapy education from diabetes educator (DE) and were trained to use the My Dose Coach (MDC) app for titration guidance according to an algorithm prepared by endocrinology provider (EP). Patients were asked to return for a 3-month (mo) follow-up clinic visit. Patients who successfully reached glycemic target were invited to Phase 2. Those who did not reach glycemic target were invited to continue titrating with the app for another 3 mo. Phase 2 Maintenance: At 3-mo clinic visit, an EP or DE trained patients the MDC Maintenance Module to support proper insulin dosing for another 3 mo. Patients were surveyed (0, 3, 6 mo) to assess changes in behavioral and psychosocial factors that influence diabetes self-management and MDC acceptability. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mild Hypoglycemic Event | Endocrine disorders | Systematic Assessment | Mild/asymptomatic hypoglycemia - blood glucose <70 mg/dl and no symptoms |
The trial was implemented during the COVID-19 pandemic and there were restrictions and challenges with meeting enrollment goals. Early on in the study, a technical issue with the intervention app was discovered and required that the study be paused while the issue was addressed, further impacting enrollment goals. Also, the study design included a historic control group to make best use of available resources, which limited comparisons among study groups.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Linda Siminerio | University of Pittsburgh | 412-559-0359 | similx@upmc.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 29, 2021 | Dec 19, 2023 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 26, 2021 | Dec 19, 2023 | ICF_001.pdf |
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|
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| Standard Insulin Therapy Education | 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. |
|
Change in fasting blood glucose from baseline to 6 months for the intervention group.
| Baseline to 6 months |
| Change From 3 Months in Fasting Blood Glucose at 6 Months | Chang in fasting blood glucose from month 3 to 6 for the intervention group. | Months 3 to 6 |
| Change From Baseline in Hemoglobin A1c at 6 Months | Average change in hemoglobin A1c from baseline to 6 months for the intervention group. | Baseline to 6 months |
| Change From 3 Months in Hemoglobin A1c at 6 Months | Average change in hemoglobin A1c from 3 months to 6 months for the intervention group. | Months 3 to 6 |
| Proportion of Patients Who Achieve Glycemic Targets | Achieving glycemic target defined as reduction in hemoglobin A1c <7% by 3 months after baseline | 3 months |
| Proportion of Patients Who Maintain Glycemic Targets | Maintaining glycemic target defined as maintaining a hemoglobin A1c <7% at 6 months for those who achieved this target at 3 months in the intervention group. | 6 months |
| Change From Baseline in Diabetes Distress at 3 Months | Diabetes distress was evaluated with the 17-item Diabetes Distress Scale, which assesses four dimensions of distress - emotional, regimen, interpersonal and physician, and has shown a consistent pattern of relationships with HbA1c, diabetes self-efficacy, diet and physical activity in multiple samples of patients with T2DM. Individual items are scored from 1 to 6; total scores are the average of all individual item scores; higher scores indicate greater distress. Possible scores range from 1 to 6. | Baseline to 3 months |
| Change From Baseline in Diabetes Distress at 6 Months | Diabetes distress was evaluated with the 17-item Diabetes Distress Scale, which assesses four dimensions of distress - emotional, regimen, interpersonal and physician, and has shown a consistent pattern of relationships with HbA1c, diabetes self-efficacy, diet and physical activity in multiple samples of patients with T2DM. Individual items are scored from 1 to 6; total scores are the average of all individual item scores; higher scores indicate greater distress. Possible scores range from 1 to 6. | Baseline to 6 months |
| Change From 3 Months in Diabetes Distress at 6 Months | Diabetes distress was evaluated with the 17-item Diabetes Distress Scale, which assesses four dimensions of distress - emotional, regimen, interpersonal and physician, and has shown a consistent pattern of relationships with HbA1c, diabetes self-efficacy, diet and physical activity in multiple samples of patients with T2DM. Individual items are scored from 1 to 6; total scores are the average of all individual item scores; higher scores indicate greater distress. Possible scores range from 1 to 6. | Month 3 to month 6 |
| Participant Acceptability of Insulin Dosing Support System for Insulin Titration | Participants rated their acceptability of My Dose Coach using a study-specific survey. Individual items are scored from 1 to 5; total scores are the average of all individual item scores; . Possible score range 1 to 5. The higher the score, the better the rating or acceptability of the insulin dosing support system. | 3 months |
| Participant Satisfaction With Insulin Treatment | The Diabetes Medication Systems Rating Questionnaire-Short Form, was also be used to inform patient acceptability and satisfaction with insulin. This questionnaire includes 20 items to assess convenience, negative events, interference, self-monitoring of blood glucose burden, efficacy, social burden, psychological well-being, treatment satisfaction and treatment preference. All items are scored 0 to 100. Composite score is calculated as means of completed items. Possible score range is 0 to 100. The higher the score, the higher the level of satisfaction. | 6 months |
| Number of Hypoglycemic Events | Total number of hypoglycemic events where blood glucose <70mg/dl. | As reported across study period, up to 6 months |
| Number of Participants Who Experienced Severe Hypoglycemic Events. | Severe hypoglycemic events were defined a hypoglycemic events that required assistance of another person to resuscitate because blood glucoses are too low to maintain consciousness. | As reported across study period, up to 6 months |
Number of technical complaints made by participants about My Dose Coach app |
| As reported across study period, up to 6 months |
| Frequency of Escalation of Care | Frequency of endocrinology and other medical visits beyond protocol will be used to assess escalation of care | As reported across study period, up to 6 months |
| Type of Technical Complaints | Type of technical complaints made by participants about My Dose Coach app | As reported across study period, up to 6 months |
| Type of Escalation of Care | Type of endocrinology and other medical visits beyond protocol were used to assess escalation of care | As reported across study period, up to 6 months |
| 24673614 | Result | Peyrot M, Xu Y, Rubin RR. Development and validation of the Diabetes Medication System Rating Questionnaire-Short Form. Diabet Med. 2014 Oct;31(10):1237-44. doi: 10.1111/dme.12453. Epub 2014 Apr 18. |
| Withdrawal by Subject |
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| Lost to Follow-up |
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| Death |
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| BG001 | Usual Care | A retrospective comparative group was 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 were identified using data available in the electronic medical record system. Propensity score matching were used to pair intervention and usual care participants. |
| BG002 | Total | Total of all reporting groups |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
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| Hemoglobin A1c | Mean | Standard Deviation | % glycated hemoglobin |
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| OG001 | Usual Care | A retrospective comparative group was 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 were identified using data available in the electronic medical record system. Propensity score matching were used to pair intervention and usual care participants. |
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| Secondary | Change From Baseline in Fasting Blood Glucose at 3 Months | Change in fasting blood glucose from baseline to 3 months for the intervention group. | Population includes all intervention participants who completed the study and had fasting blood glucose values at both baseline and 3 month timepoints. Fasting blood glucose values were not collected for the historic usual care group so they were not included for analysis. | Posted | Mean | Standard Deviation | mg/dL | Baseline to 3 months |
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| Secondary | Change From Baseline in Fasting Blood Glucose at 6 Months | Change in fasting blood glucose from baseline to 6 months for the intervention group. | Participants in the intervention group who completed the study and had fasting blood glucose values recorded at time points of comparison. Data were not collected for the historic usual care group so they were not included for analysis of this outcome. | Posted | Mean | Standard Deviation | mg/dl | Baseline to 6 months |
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| Secondary | Change From 3 Months in Fasting Blood Glucose at 6 Months | Chang in fasting blood glucose from month 3 to 6 for the intervention group. | Participants in the intervention group who completed the study and had fasting blood glucose values recorded at time points of comparison. Data were not collected for the historic usual care group so they were not included for analysis of this outcome. | Posted | Mean | Standard Deviation | mg/dL | Months 3 to 6 |
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| Secondary | Change From Baseline in Hemoglobin A1c at 6 Months | Average change in hemoglobin A1c from baseline to 6 months for the intervention group. | All participants in the intervention group with available hemoglobin A1 data at the specified time points were included. Data were not collected for the historic usual care group so they were not included for analysis of this outcome. | Posted | Mean | Standard Deviation | % glycated hemoglobin | Baseline to 6 months |
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| Secondary | Change From 3 Months in Hemoglobin A1c at 6 Months | Average change in hemoglobin A1c from 3 months to 6 months for the intervention group. | All participants in the intervention group who had hemoglobin A1c values available at time points of comparison were included. Data were not collected for the historic usual care group so they were not included for analysis for this outcome. | Posted | Mean | Standard Deviation | % glycated hemoglobin | Months 3 to 6 |
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| Secondary | Proportion of Patients Who Achieve Glycemic Targets | Achieving glycemic target defined as reduction in hemoglobin A1c <7% by 3 months after baseline | Intervention group includes those participants who completed the study and had 3 month hemoglobin A1c values. Usual care is a historical comparative group. | Posted | Number | proportion of participants | 3 months |
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| Secondary | Proportion of Patients Who Maintain Glycemic Targets | Maintaining glycemic target defined as maintaining a hemoglobin A1c <7% at 6 months for those who achieved this target at 3 months in the intervention group. | Participants in the intervention group who reached their target glycemic goal (hemoglobin A1c <7%) at 3 months and had hemoglobin A1c values available at 6 months. Data were not collected for the historic usual care group so they were not included for analysis for this outcome. | Posted | Number | proportion of participants | 6 months |
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| Secondary | Change From Baseline in Diabetes Distress at 3 Months | Diabetes distress was evaluated with the 17-item Diabetes Distress Scale, which assesses four dimensions of distress - emotional, regimen, interpersonal and physician, and has shown a consistent pattern of relationships with HbA1c, diabetes self-efficacy, diet and physical activity in multiple samples of patients with T2DM. Individual items are scored from 1 to 6; total scores are the average of all individual item scores; higher scores indicate greater distress. Possible scores range from 1 to 6. | All participants in the intervention group who completed the study. Data were not collected for the historic usual care group so they were not included for analysis for this outcome. | Posted | Mean | Standard Deviation | Score on scale | Baseline to 3 months |
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| Secondary | Change From Baseline in Diabetes Distress at 6 Months | Diabetes distress was evaluated with the 17-item Diabetes Distress Scale, which assesses four dimensions of distress - emotional, regimen, interpersonal and physician, and has shown a consistent pattern of relationships with HbA1c, diabetes self-efficacy, diet and physical activity in multiple samples of patients with T2DM. Individual items are scored from 1 to 6; total scores are the average of all individual item scores; higher scores indicate greater distress. Possible scores range from 1 to 6. | All intervention participants who completed the study. Data were not collected for the historic usual care group so they were not included for analysis for this outcome. | Posted | Mean | Standard Deviation | Score on scale | Baseline to 6 months |
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| Secondary | Change From 3 Months in Diabetes Distress at 6 Months | Diabetes distress was evaluated with the 17-item Diabetes Distress Scale, which assesses four dimensions of distress - emotional, regimen, interpersonal and physician, and has shown a consistent pattern of relationships with HbA1c, diabetes self-efficacy, diet and physical activity in multiple samples of patients with T2DM. Individual items are scored from 1 to 6; total scores are the average of all individual item scores; higher scores indicate greater distress. Possible scores range from 1 to 6. | All participants who completed the intervention. Data were not collected for the historic usual care group so they were not included for analysis for this outcome. | Posted | Mean | Standard Deviation | Score on scale | Month 3 to month 6 |
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| Secondary | Participant Acceptability of Insulin Dosing Support System for Insulin Titration | Participants rated their acceptability of My Dose Coach using a study-specific survey. Individual items are scored from 1 to 5; total scores are the average of all individual item scores; . Possible score range 1 to 5. The higher the score, the better the rating or acceptability of the insulin dosing support system. | All participants in the intervention who completed the study. | Posted | Mean | Standard Deviation | Score on scale | 3 months |
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| Secondary | Participant Satisfaction With Insulin Treatment | The Diabetes Medication Systems Rating Questionnaire-Short Form, was also be used to inform patient acceptability and satisfaction with insulin. This questionnaire includes 20 items to assess convenience, negative events, interference, self-monitoring of blood glucose burden, efficacy, social burden, psychological well-being, treatment satisfaction and treatment preference. All items are scored 0 to 100. Composite score is calculated as means of completed items. Possible score range is 0 to 100. The higher the score, the higher the level of satisfaction. | All participants who completed the intervention. Data were not collected for the historic usual care group so they were not included for analysis for this outcome. | Posted | Mean | Standard Deviation | Score on scale | 6 months |
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| Secondary | Number of Hypoglycemic Events | Total number of hypoglycemic events where blood glucose <70mg/dl. | All participants in the intervention who completed the study. Did not collect on historic control group. | Posted | Number | Events | As reported across study period, up to 6 months |
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| Secondary | Number of Participants Who Experienced Severe Hypoglycemic Events. | Severe hypoglycemic events were defined a hypoglycemic events that required assistance of another person to resuscitate because blood glucoses are too low to maintain consciousness. | All participants in the intervention who completed the study. Did not collect on historic control group. | Posted | Count of Participants | Participants | As reported across study period, up to 6 months |
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| Other Pre-specified | Participant Use of My Dose Coach | Patient use of My Dose Coach app was track through the app's data analytics software platform. High app use was defined as logging in app >3days per week. | All intervention participants who completed the study. | Posted | Count of Participants | Participants | As reported across study period, up to 6 months |
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| Other Pre-specified | Number of Technical Complaints | Number of technical complaints made by participants about My Dose Coach app | All participants enrolled in intervention. | Posted | Number | Number of complaints | As reported across study period, up to 6 months |
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| Other Pre-specified | Frequency of Escalation of Care | Frequency of endocrinology and other medical visits beyond protocol will be used to assess escalation of care | All participants enrolled in the intervention. Data were not collected for the historic usual care group so they were not included for analysis for this outcome. | Posted | Number | Number of visits | As reported across study period, up to 6 months |
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| Other Pre-specified | Type of Technical Complaints | Type of technical complaints made by participants about My Dose Coach app | All participants enrolled in intervention | Posted | Number | Type of complaints | As reported across study period, up to 6 months |
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| Other Pre-specified | Type of Escalation of Care | Type of endocrinology and other medical visits beyond protocol were used to assess escalation of care | All patients enrolled in the intervention. Did not collect on historic control group. | Posted | Number | Type of escalation of care | As reported across study period, up to 6 months |
|
|
|
| 2 |
| 60 |
| 0 |
| 60 |
| 15 |
| 60 |
| EG001 | Usual Care | A retrospective comparative group was 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 were identified using data available in the electronic medical record system. Propensity score matching were used to pair intervention and usual care participants. | 0 | 33 | 0 | 33 | 0 | 33 |
|
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