Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to see if the use of the InPen® for teens and young adults up to age 21 years with type 1 diabetes helps to decrease burden and improve glycemic control.
Investigators will perform a randomized, cross-over prospective interventional study. Half of the participants will be randomized to the InPen® and the other half will continue with their conventional insulin injection protocol. After 90 days, participants will switch to the second arm. Randomization will occur via block randomization. Teaching to use the InPen® will be done by Sarah Jackson, DO with supervision by Ana Creo, MD, which can be done by a telemedicine visit if it does not align with clinic visit. You will be followed for three months with hemoglobin A1c at the beginning and the end of the study. Data from the (Continuous Glucose Monitor (CGM) and InPen® will be analyzed including time in glucose goal range (70-180 mg/dL), glucose standard deviation, percentage of time that is spent high (>180-250 mg/dL), very high(> 250 mg/dL), low(54-70 mg/dL) and very low(<54 mg/dL), along with total daily insulin dose. Data on missed insulin doses will be assessed via data from the InPen®. You will be randomized to traditional injections we will ask them to record missed insulin doses weekly. You should still adjust insulin doses at home, like they do at baseline. If insulin adjustments are made while in one arm of the study they should still continue that dosing when they cross over. Investigators will also assess quality of life and fatigue related to technology with surveys prior to start of the study and at the end. Specifically, investigators will assess diabetes distress, transition readiness, and parental experience of childhood illness scales. Investigators will also utilize the insulin delivery satisfaction survey to assess how you view your current regimen and then how you view the effects of the InPen in managing your type 1 diabetes.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| InPen® and CGM, then standard of care and CGM | Experimental | Adolescents and young adults (13-21 years) identified with having type 1 diabetes and currently receiving insulin injections with a continuous glucose monitor (CGM) will use the InPen® and CGM for the first 90 days then switch to standard of care with traditional insulin injections and CGM for 90 days. |
|
| Standard of care and CGM, then InPen® and CGM | Experimental | Adolescents and young adults (13-21 years) identified with having type 1 diabetes and currently receiving insulin injections with a continuous glucose monitor (CGM) will receive standard of care with traditional insulin injections and CGM for first 90 days then switch to the InPen® and CGM for 90 days. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| InPen® | Device | A smartpen that has been FDA approved for children with diabetes age seven years and older that uses an app on a smartphone to help calculate insulin doses using the amount of carbohydrates that will be consumed at a meal along with what the current blood sugar reading is, to give a correction dose as well. The InPen app also serves as a log book to record insulin doses given, blood sugar at the time of a meal, and amount of carbohydrate eaten. |
| Measure | Description | Time Frame |
|---|---|---|
| Glucose Time in Range | The percentage of time that glucose readings are in goal range (70-180 mg/dL) | 3 months |
| InPen® Missed Insulin Injections | Number of missed insulin injections after 30 and 90 days of InPen and CGM | 30 and 90 days |
| Change in Hemoglobin A1c | Hemoglobin is a protein within red blood cells. As glucose enters the bloodstream, it binds to hemoglobin, or glycates. The more glucose that enters the bloodstream, the higher the amount of glycated hemoglobin. An A1C level below 5.7 percent is considered normal. Unit of measure = percent of glycated hemoglobin | Baseline, 3 months |
| Glucose | Mean glucose levels at 6 months. Sugar in the form of glucose in the blood. The concentration of glucose in the blood. A healthy normal range is 70 to 99 mg/dL | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Diabetes Distress Scale Score | Measured using the Diabetes Distress Scale (DDS) which identifies 17 potential problem areas that people with diabetes may experience and asked subjects to rate their perceived degree of distressed during the past month; using a scale of 1 = "Not a problem at all", 6 = "A very serious problem." Total scores range from 17-102, lower scores indicating less distress and higher scores indicating more distress |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ana Creo, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
Not provided
| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | InPen® and CGM, Then Standard of Care and CGM | Adolescents and young adults (13-21 years) identified with having type 1 diabetes and currently receiving insulin injections with a continuous glucose monitor (CGM) used the InPen® and CGM for the first 90 days then switched to standard of care with traditional insulin injections and CGM for 90 days. InPen®: A smartpen that has been FDA approved for children with diabetes age seven years and older that uses an app on a smartphone to help calculate insulin doses using the amount of carbohydrates that will be consumed at a meal along with what the current blood sugar reading is, to give a correction dose as well. The InPen app also serves as a log book to record insulin doses given, blood sugar at the time of a meal, and amount of carbohydrate eaten. |
| FG001 | Standard of Care and CGM, Then InPen® and CGM | Adolescents and young adults (13-21 years) identified with having type 1 diabetes and currently receiving insulin injections with a continuous glucose monitor (CGM) received standard of care with traditional insulin injections and CMG for first 90 days then switched to the InPen® and CMG for 90 days. InPen®: A smartpen that has been FDA approved for children with diabetes age seven years and older that uses an app on a smartphone to help calculate insulin doses using the amount of carbohydrates that will be consumed at a meal along with what the current blood sugar reading is, to give a correction dose as well. The InPen app also serves as a log book to record insulin doses given, blood sugar at the time of a meal, and amount of carbohydrate eaten. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Intervention (90 Days) |
| |||||||||||||
| Second Intervention (90 Days) |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | InPen® and CGM, Then Standard of Care and CGM | Adolescents and young adults (13-21 years) identified with having type 1 diabetes and currently receiving insulin injections with a continuous glucose monitor (CGM) used the InPen® and CMG for the first 90 days then switched to standard of care with traditional insulin injections and CMG for 90 days. InPen®: A smartpen that has been FDA approved for children with diabetes age seven years and older that uses an app on a smartphone to help calculate insulin doses using the amount of carbohydrates that will be consumed at a meal along with what the current blood sugar reading is, to give a correction dose as well. The InPen app also serves as a log book to record insulin doses given, blood sugar at the time of a meal, and amount of carbohydrate eaten. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Glucose Time in Range | The percentage of time that glucose readings are in goal range (70-180 mg/dL) | Posted | Mean | Standard Deviation | percentage of time in range | 3 months |
|
Adverse Events were assessed for all subjects during first treatment period (90 days) and second treatment period (90 days) for a total of approximately 6 months.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | InPen® and Continues Glucose Monitoring (CGM) | Subjects who received InPen® and CGM in either the first or last 90 days of the study |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Ana L. Creo, M.D. | Mayo Clinic | 507-284-3300 | Creo.Ana@mayo.edu |
Not provided
| 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 | Aug 12, 2021 | Oct 5, 2023 | Prot_SAP_000.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Baseline, 3 months |
| Change in Transition Readiness | Mean change in transition readiness as measured by using the Transition Readiness Assessment Questionnaire (TRAQ). A 20-item questionnaire assessing the skill levels that are important for transition to adult health care; using a scale of 1 = "No, I do not know how", 5 = "Yes, I always do this when I need to." Total scores range from 20 - 100, lower scores indicating lower readiness and higher scores indicating greater readiness. | Baseline, 3 months |
| Change in Self-Efficacy for Managing Chronic Conditions - Managing Medications and Treatment Score | Measured using the Self-Efficacy for Managing Chronic Conditions - Managing Medications and Treatment questionnaire. A 14-item questionnaire rating the confidence level for managing chronic conditions, medications and treatment; using a scale of 1 = "I am not at all confident", 5 = "I am very confident." Total scores range from 14-70, lower scores indicating lower confidence and higher scores indicating higher confidence. | Baseline, 3 months |
| NOT COMPLETED |
|
| BG001 | Standard of Care and CGM, Then InPen® and CGM | Adolescents and young adults (13-21 years) identified with having type 1 diabetes and currently receiving insulin injections with a continuous glucose monitor (CGM) received standard of care with traditional insulin injections and CMG for first 90 days then switched to the InPen® and CMG for 90 days. InPen®: A smartpen that has been FDA approved for children with diabetes age seven years and older that uses an app on a smartphone to help calculate insulin doses using the amount of carbohydrates that will be consumed at a meal along with what the current blood sugar reading is, to give a correction dose as well. The InPen app also serves as a log book to record insulin doses given, blood sugar at the time of a meal, and amount of carbohydrate eaten. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|
| Participants |
|
|
| Primary | InPen® Missed Insulin Injections | Number of missed insulin injections after 30 and 90 days of InPen and CGM | Only InPen & CGM subjects data were collected and analyzed for this outcome measure. | Posted | Mean | Standard Deviation | missed insulin injections | 30 and 90 days |
|
|
|
| Primary | Change in Hemoglobin A1c | Hemoglobin is a protein within red blood cells. As glucose enters the bloodstream, it binds to hemoglobin, or glycates. The more glucose that enters the bloodstream, the higher the amount of glycated hemoglobin. An A1C level below 5.7 percent is considered normal. Unit of measure = percent of glycated hemoglobin | Posted | Mean | Standard Deviation | percent of glycated hemoglobin | Baseline, 3 months |
|
|
|
| Primary | Glucose | Mean glucose levels at 6 months. Sugar in the form of glucose in the blood. The concentration of glucose in the blood. A healthy normal range is 70 to 99 mg/dL | Posted | Median | Inter-Quartile Range | mg/dL | 3 months |
|
|
|
| Secondary | Change in Diabetes Distress Scale Score | Measured using the Diabetes Distress Scale (DDS) which identifies 17 potential problem areas that people with diabetes may experience and asked subjects to rate their perceived degree of distressed during the past month; using a scale of 1 = "Not a problem at all", 6 = "A very serious problem." Total scores range from 17-102, lower scores indicating less distress and higher scores indicating more distress | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months |
|
|
|
| Secondary | Change in Transition Readiness | Mean change in transition readiness as measured by using the Transition Readiness Assessment Questionnaire (TRAQ). A 20-item questionnaire assessing the skill levels that are important for transition to adult health care; using a scale of 1 = "No, I do not know how", 5 = "Yes, I always do this when I need to." Total scores range from 20 - 100, lower scores indicating lower readiness and higher scores indicating greater readiness. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months |
|
|
|
| Secondary | Change in Self-Efficacy for Managing Chronic Conditions - Managing Medications and Treatment Score | Measured using the Self-Efficacy for Managing Chronic Conditions - Managing Medications and Treatment questionnaire. A 14-item questionnaire rating the confidence level for managing chronic conditions, medications and treatment; using a scale of 1 = "I am not at all confident", 5 = "I am very confident." Total scores range from 14-70, lower scores indicating lower confidence and higher scores indicating higher confidence. | Posted | Mean | Standard Deviation | score on a scale | Baseline, 3 months |
|
|
|
| 0 |
| 13 |
| 0 |
| 13 |
| 0 |
| 13 |
| EG001 | Standard of Care and Continues Glucose Monitoring (CGM) | Subjects who received standard of care and CGM in either the first or last 90 days of the study | 0 | 13 | 0 | 13 | 0 | 13 |
Not provided
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |