Type 1 Diabetes
Conditions
Keywords
Adolescents, Young Adults, Continuous Glucose monitoring (CGM)
Brief summary
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.
Detailed description
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.
Interventions
DEVICEInPen®
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.
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
13 Years to 21 Years
Healthy volunteers
No
Inclusion criteria
* Individuals between the ages of 13 and 21 years. * Patients with Type 1 diabetes for at least 6 months * Defined as either a c peptide \<1 , one or more positive diabetes autoantibodies, or a clinical diagnosis with age of onset prior to puberty * Patients who currently receive insulin injections with a CGM. * English speaking. * Have access to a smart phone. on an insulin to carbohydrate ratio
Exclusion criteria
* Individuals less than 13 * Non-English speaking. * No access to a smart phone. * Intellectual disability that would impact their ability to utilize the technology * Known pregnant women taking chronic steroids (equivalent equal to or greater then 5mg of prednisone daily)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Glucose Time in Range | 3 months | The percentage of time that glucose readings are in goal range (70-180 mg/dL) |
| InPen® Missed Insulin Injections | 30 and 90 days | Number of missed insulin injections after 30 and 90 days of InPen and CGM |
| Change in Hemoglobin A1c | Baseline, 3 months | 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 |
| Glucose | 3 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Transition Readiness | Baseline, 3 months | 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. |
| Change in Self-Efficacy for Managing Chronic Conditions - Managing Medications and Treatment Score | Baseline, 3 months | 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. |
| Change in Diabetes Distress Scale Score | Baseline, 3 months | 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 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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. | 5 |
| 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. | 8 |
| Total | 13 |
Baseline characteristics
| Characteristic | Standard of Care and CGM, Then InPen® and CGM | Total | InPen® and CGM, Then Standard of Care and CGM |
|---|---|---|---|
| Age, Continuous | 15.9 years STANDARD_DEVIATION 1.89 | 15.9 years STANDARD_DEVIATION 1.6 | 16.0 years STANDARD_DEVIATION 1.22 |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 8 participants | 13 participants | 5 participants |
| Sex: Female, Male Female | 2 Participants | 2 Participants | 0 Participants |
| Sex: Female, Male Male | 6 Participants | 11 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 13 |
| other Total, other adverse events | 0 / 13 | 0 / 13 |
| serious Total, serious adverse events | 0 / 13 | 0 / 13 |
Outcome results
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
Time frame: Baseline, 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| InPen® and Continues Glucose Monitoring (CGM) | Change in Hemoglobin A1c | -0.1 percent of glycated hemoglobin | Standard Deviation 0.6 |
| Standard of Care and Continues Glucose Monitoring (CGM) | Change in Hemoglobin A1c | -0.3 percent of glycated hemoglobin | Standard Deviation 0.7 |
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
Time frame: 3 months
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| InPen® and Continues Glucose Monitoring (CGM) | Glucose | 198 mg/dL |
| Standard of Care and Continues Glucose Monitoring (CGM) | Glucose | 180 mg/dL |
Primary
Glucose Time in Range
The percentage of time that glucose readings are in goal range (70-180 mg/dL)
Time frame: 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| InPen® and Continues Glucose Monitoring (CGM) | Glucose Time in Range | 46 percentage of time in range | Standard Deviation 22 |
| Standard of Care and Continues Glucose Monitoring (CGM) | Glucose Time in Range | 49 percentage of time in range | Standard Deviation 20 |
Primary
InPen® Missed Insulin Injections
Number of missed insulin injections after 30 and 90 days of InPen and CGM
Time frame: 30 and 90 days
Population: Only InPen \& CGM subjects data were collected and analyzed for this outcome measure.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| InPen® and Continues Glucose Monitoring (CGM) | InPen® Missed Insulin Injections | 30 days | 51.2 missed insulin injections | Standard Deviation 26.3 |
| InPen® and Continues Glucose Monitoring (CGM) | InPen® Missed Insulin Injections | 90 days | 212.6 missed insulin injections | Standard Deviation 76.1 |
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
Time frame: Baseline, 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| InPen® and Continues Glucose Monitoring (CGM) | Change in Diabetes Distress Scale Score | -0.038 score on a scale | Standard Deviation 0.231 |
| Standard of Care and Continues Glucose Monitoring (CGM) | Change in Diabetes Distress Scale Score | 0.075 score on a scale | Standard Deviation 0.283 |
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.
Time frame: Baseline, 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| InPen® and Continues Glucose Monitoring (CGM) | Change in Self-Efficacy for Managing Chronic Conditions - Managing Medications and Treatment Score | 0.058 score on a scale | Standard Deviation 0.464 |
| Standard of Care and Continues Glucose Monitoring (CGM) | Change in Self-Efficacy for Managing Chronic Conditions - Managing Medications and Treatment Score | 0.074 score on a scale | Standard Deviation 0.514 |
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.
Time frame: Baseline, 3 months
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| InPen® and Continues Glucose Monitoring (CGM) | Change in Transition Readiness | 0.149 score on a scale | Standard Deviation 0.785 |
| Standard of Care and Continues Glucose Monitoring (CGM) | Change in Transition Readiness | -0.029 score on a scale | Standard Deviation 0.739 |