Trial Outcomes & Findings for A Study to Assess the Effect of Smart Insulin Pens on Glycemic Control and Diabetes-related Burdens (NCT NCT05036343)

Results Overview

The percentage of time that glucose readings are in goal range (70-180 mg/dL)

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

13 participants

Primary outcome timeframe

3 months

Results posted on

2024-01-02

Participant Flow

Participant milestones

Participant milestones
Measure	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.	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.
First Intervention (90 Days) STARTED	5	8
First Intervention (90 Days) COMPLETED	5	8
First Intervention (90 Days) NOT COMPLETED	0	0
Second Intervention (90 Days) STARTED	5	8
Second Intervention (90 Days) COMPLETED	5	8
Second Intervention (90 Days) NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	InPen® and CGM, Then Standard of Care and CGM n=5 Participants 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.	Standard of Care and CGM, Then InPen® and CGM n=8 Participants 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.	Total n=13 Participants Total of all reporting groups
Age, Continuous	16.0 years STANDARD_DEVIATION 1.22 • n=5 Participants	15.9 years STANDARD_DEVIATION 1.89 • n=8 Participants	15.9 years STANDARD_DEVIATION 1.6 • n=13 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	2 Participants n=8 Participants	2 Participants n=13 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	6 Participants n=8 Participants	11 Participants n=13 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	5 participants n=5 Participants	8 participants n=8 Participants	13 participants n=13 Participants

PRIMARY outcome

Timeframe: 3 months

The percentage of time that glucose readings are in goal range (70-180 mg/dL)

Outcome measures

Outcome measures
Measure	InPen® and Continues Glucose Monitoring (CGM) n=13 Participants Subjects who received InPen® and CGM in either the first or last 90 days of the study	Standard of Care and Continues Glucose Monitoring (CGM) n=13 Participants Subjects who received standard of care and CGM in either the first or last 90 days of the study
Glucose Time in Range	46 percentage of time in range Standard Deviation 22	49 percentage of time in range Standard Deviation 20

PRIMARY outcome

Timeframe: 30 and 90 days

Population: Only InPen \& CGM subjects data were collected and analyzed for this outcome measure.

Number of missed insulin injections after 30 and 90 days of InPen and CGM

Outcome measures

Outcome measures
Measure	InPen® and Continues Glucose Monitoring (CGM) n=13 Participants Subjects who received InPen® and CGM in either the first or last 90 days of the study	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
InPen® Missed Insulin Injections 30 days	51.2 missed insulin injections Standard Deviation 26.3	—
InPen® Missed Insulin Injections 90 days	212.6 missed insulin injections Standard Deviation 76.1	—

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	InPen® and Continues Glucose Monitoring (CGM) n=13 Participants Subjects who received InPen® and CGM in either the first or last 90 days of the study	Standard of Care and Continues Glucose Monitoring (CGM) n=13 Participants Subjects who received standard of care and CGM in either the first or last 90 days of the study
Change in Hemoglobin A1c	-0.1 percent of glycated hemoglobin Standard Deviation 0.6	-0.3 percent of glycated hemoglobin Standard Deviation 0.7

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	InPen® and Continues Glucose Monitoring (CGM) n=13 Participants Subjects who received InPen® and CGM in either the first or last 90 days of the study	Standard of Care and Continues Glucose Monitoring (CGM) n=13 Participants Subjects who received standard of care and CGM in either the first or last 90 days of the study
Glucose	198 mg/dL Interval 178.0 to 212.0	180 mg/dL Interval 167.0 to 213.0

SECONDARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	InPen® and Continues Glucose Monitoring (CGM) n=13 Participants Subjects who received InPen® and CGM in either the first or last 90 days of the study	Standard of Care and Continues Glucose Monitoring (CGM) n=13 Participants Subjects who received standard of care and CGM in either the first or last 90 days of the study
Change in Diabetes Distress Scale Score	-0.038 score on a scale Standard Deviation 0.231	0.075 score on a scale Standard Deviation 0.283

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	InPen® and Continues Glucose Monitoring (CGM) n=13 Participants Subjects who received InPen® and CGM in either the first or last 90 days of the study	Standard of Care and Continues Glucose Monitoring (CGM) n=13 Participants Subjects who received standard of care and CGM in either the first or last 90 days of the study
Change in Transition Readiness	0.149 score on a scale Standard Deviation 0.785	-0.029 score on a scale Standard Deviation 0.739

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	InPen® and Continues Glucose Monitoring (CGM) n=13 Participants Subjects who received InPen® and CGM in either the first or last 90 days of the study	Standard of Care and Continues Glucose Monitoring (CGM) n=13 Participants Subjects who received standard of care and CGM in either the first or last 90 days of the study
Change in Self-Efficacy for Managing Chronic Conditions - Managing Medications and Treatment Score	0.058 score on a scale Standard Deviation 0.464	0.074 score on a scale Standard Deviation 0.514

Adverse Events

InPen® and Continues Glucose Monitoring (CGM)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard of Care and Continues Glucose Monitoring (CGM)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ana L. Creo, M.D.

Mayo Clinic

Phone: 507-284-3300

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place