Trial Outcomes & Findings for A Study of Rapid-Acting Mealtime Insulin in Children and Adolescents With Newly Diagnosed Type 1 Diabetes Mellitus (NCT NCT04157738)
NCT ID: NCT04157738
Last Updated: 2021-09-30
Results Overview
The capacity for recruitment was assessed, including all subjects that signed the Informed Consent Form (ICF).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
24 participants
Primary outcome timeframe
4 months post-intervention
Results posted on
2021-09-30
Participant Flow
Participant milestones
| Measure |
Fixed Group
Children and adolescents with newly-diagnosed T1DM will receive a fixed mealtime carbohydrate with a fixed mealtime insulin dose, that is a simplified regimen that provides a set amount of insulin for a set amount of carbohydrates, and ensures that each dose and each meal is consistent.
Rapid-Acting Insulin: Prior to discharge, all subjects will receive a regimen that includes a Meal-time insulin and carbohydrate regimen (number of units of insulin, number of carbohydrates, and/or ICR)
Long acting insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)
|
Insulin to Carbohydrate Ratio (ICR) Group
Children and adolescents with newly-diagnosed T1DM will receive an Insulin to carbohydrate ratio (ICR) with variable carbohydrate intake mealtime regimen
Rapid-Acting Insulin: Prior to discharge, all subjects will receive a regimen that includes a Meal-time insulin and carbohydrate regimen (number of units of insulin, number of carbohydrates, and/or ICR)
Long acting insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)
|
|---|---|---|
|
Overall Study
STARTED
|
12
|
12
|
|
Overall Study
COMPLETED
|
11
|
10
|
|
Overall Study
NOT COMPLETED
|
1
|
2
|
Reasons for withdrawal
| Measure |
Fixed Group
Children and adolescents with newly-diagnosed T1DM will receive a fixed mealtime carbohydrate with a fixed mealtime insulin dose, that is a simplified regimen that provides a set amount of insulin for a set amount of carbohydrates, and ensures that each dose and each meal is consistent.
Rapid-Acting Insulin: Prior to discharge, all subjects will receive a regimen that includes a Meal-time insulin and carbohydrate regimen (number of units of insulin, number of carbohydrates, and/or ICR)
Long acting insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)
|
Insulin to Carbohydrate Ratio (ICR) Group
Children and adolescents with newly-diagnosed T1DM will receive an Insulin to carbohydrate ratio (ICR) with variable carbohydrate intake mealtime regimen
Rapid-Acting Insulin: Prior to discharge, all subjects will receive a regimen that includes a Meal-time insulin and carbohydrate regimen (number of units of insulin, number of carbohydrates, and/or ICR)
Long acting insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)
|
|---|---|---|
|
Overall Study
Moved out of state
|
0
|
2
|
|
Overall Study
Did not show up to the Follow-up appointment
|
1
|
0
|
Baseline Characteristics
A Study of Rapid-Acting Mealtime Insulin in Children and Adolescents With Newly Diagnosed Type 1 Diabetes Mellitus
Baseline characteristics by cohort
| Measure |
Fixed Group
n=12 Participants
Children and adolescents with newly-diagnosed T1DM will receive a fixed mealtime carbohydrate with a fixed mealtime insulin dose, that is a simplified regimen that provides a set amount of insulin for a set amount of carbohydrates, and ensures that each dose and each meal is consistent.
Rapid-Acting Insulin: Prior to discharge, all subjects will receive a regimen that includes a Meal-time insulin and carbohydrate regimen (number of units of insulin, number of carbohydrates, and/or ICR)
Long acting insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)
|
Insulin to Carbohydrate Ratio (ICR) Group
n=12 Participants
Children and adolescents with newly-diagnosed T1DM will receive an Insulin to carbohydrate ratio (ICR) with variable carbohydrate intake mealtime regimen
Rapid-Acting Insulin: Prior to discharge, all subjects will receive a regimen that includes a Meal-time insulin and carbohydrate regimen (number of units of insulin, number of carbohydrates, and/or ICR)
Long acting insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)
|
Total
n=24 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
10 years
n=5 Participants
|
11 years
n=7 Participants
|
11 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
12 participants
n=5 Participants
|
12 participants
n=7 Participants
|
24 participants
n=5 Participants
|
|
Onset with Acidosis
Yes
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Onset with Acidosis
No
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Pubertal at onset
Yes
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Pubertal at onset
No
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 4 months post-interventionThe capacity for recruitment was assessed, including all subjects that signed the Informed Consent Form (ICF).
Outcome measures
| Measure |
Fixed Group
n=12 Participants
Children and adolescents with newly-diagnosed T1DM will receive a fixed mealtime carbohydrate with a fixed mealtime insulin dose, that is a simplified regimen that provides a set amount of insulin for a set amount of carbohydrates, and ensures that each dose and each meal is consistent.
Rapid-Acting Insulin: Prior to discharge, all subjects will receive a regimen that includes a Meal-time insulin and carbohydrate regimen (number of units of insulin, number of carbohydrates, and/or ICR)
Long acting insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)
|
Insulin to Carbohydrate Ratio (ICR) Group
n=12 Participants
Children and adolescents with newly-diagnosed T1DM will receive an Insulin to carbohydrate ratio (ICR) with variable carbohydrate intake mealtime regimen
Rapid-Acting Insulin: Prior to discharge, all subjects will receive a regimen that includes a Meal-time insulin and carbohydrate regimen (number of units of insulin, number of carbohydrates, and/or ICR)
Long acting insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)
|
|---|---|---|
|
Number of All Consented Participants
|
12 Participants
|
12 Participants
|
PRIMARY outcome
Timeframe: 4 months post-interventionNumber of participants that were able to complete all study visits, including the visits in-person at 1 month and 4 months post-randomization.
Outcome measures
| Measure |
Fixed Group
n=12 Participants
Children and adolescents with newly-diagnosed T1DM will receive a fixed mealtime carbohydrate with a fixed mealtime insulin dose, that is a simplified regimen that provides a set amount of insulin for a set amount of carbohydrates, and ensures that each dose and each meal is consistent.
Rapid-Acting Insulin: Prior to discharge, all subjects will receive a regimen that includes a Meal-time insulin and carbohydrate regimen (number of units of insulin, number of carbohydrates, and/or ICR)
Long acting insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)
|
Insulin to Carbohydrate Ratio (ICR) Group
n=12 Participants
Children and adolescents with newly-diagnosed T1DM will receive an Insulin to carbohydrate ratio (ICR) with variable carbohydrate intake mealtime regimen
Rapid-Acting Insulin: Prior to discharge, all subjects will receive a regimen that includes a Meal-time insulin and carbohydrate regimen (number of units of insulin, number of carbohydrates, and/or ICR)
Long acting insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)
|
|---|---|---|
|
Number of Participants That Completed All Visits
|
11 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: 1 month post-intervention and 4 months post-interventionCaregiver treatment adherence was assessed using a blood glucose log. Subjects and caregivers recorded blood glucose levels and the amount/type of insulin given. This data was used to calculate adherence as a percentage ranging from 0% (no adherence) to 100% (full adherence).
Outcome measures
| Measure |
Fixed Group
n=12 Participants
Children and adolescents with newly-diagnosed T1DM will receive a fixed mealtime carbohydrate with a fixed mealtime insulin dose, that is a simplified regimen that provides a set amount of insulin for a set amount of carbohydrates, and ensures that each dose and each meal is consistent.
Rapid-Acting Insulin: Prior to discharge, all subjects will receive a regimen that includes a Meal-time insulin and carbohydrate regimen (number of units of insulin, number of carbohydrates, and/or ICR)
Long acting insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)
|
Insulin to Carbohydrate Ratio (ICR) Group
n=10 Participants
Children and adolescents with newly-diagnosed T1DM will receive an Insulin to carbohydrate ratio (ICR) with variable carbohydrate intake mealtime regimen
Rapid-Acting Insulin: Prior to discharge, all subjects will receive a regimen that includes a Meal-time insulin and carbohydrate regimen (number of units of insulin, number of carbohydrates, and/or ICR)
Long acting insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)
|
|---|---|---|
|
Caregiver Treatment Adherence at 1 Month and 4 Months Post-intervention
< 4 times/day at 1-month visit
|
3.2 percentage of participants
Interval 0.0 to 16.1
|
10.2 percentage of participants
Interval 2.4 to 21.4
|
|
Caregiver Treatment Adherence at 1 Month and 4 Months Post-intervention
≥ 4 times/day at 1-month visit
|
96.8 percentage of participants
Interval 83.9 to 100.0
|
89.8 percentage of participants
Interval 78.6 to 97.6
|
|
Caregiver Treatment Adherence at 1 Month and 4 Months Post-intervention
< 4 times/day at 4-month visit
|
2.6 percentage of participants
Interval 0.0 to 12.6
|
16.1 percentage of participants
Interval 2.0 to 39.2
|
|
Caregiver Treatment Adherence at 1 Month and 4 Months Post-intervention
≥ 4 times/day at 4-month visit
|
97.0 percentage of participants
Interval 87.4 to 100.0
|
83.9 percentage of participants
Interval 61.8 to 98.0
|
SECONDARY outcome
Timeframe: Baseline, 1 month post-intervention, 4 months post-interventionPopulation: Number of participants analyzed include subjects that had visits in-person at 1 month and 4 months post-randomization.
Caregiver anxiety was measured with the "parental stress scale". Caregivers completed the "parental stress scale" at initial enrollment and at each clinic follow up visit. The Parental Stress Scale includes 18 questions that are rated from 1 (strongly disagree) to 5 (strongly agree). Scoring ranges from 18 - 90. The higher the score, the higher the stress and anxiety level.
Outcome measures
| Measure |
Fixed Group
n=12 Participants
Children and adolescents with newly-diagnosed T1DM will receive a fixed mealtime carbohydrate with a fixed mealtime insulin dose, that is a simplified regimen that provides a set amount of insulin for a set amount of carbohydrates, and ensures that each dose and each meal is consistent.
Rapid-Acting Insulin: Prior to discharge, all subjects will receive a regimen that includes a Meal-time insulin and carbohydrate regimen (number of units of insulin, number of carbohydrates, and/or ICR)
Long acting insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)
|
Insulin to Carbohydrate Ratio (ICR) Group
n=12 Participants
Children and adolescents with newly-diagnosed T1DM will receive an Insulin to carbohydrate ratio (ICR) with variable carbohydrate intake mealtime regimen
Rapid-Acting Insulin: Prior to discharge, all subjects will receive a regimen that includes a Meal-time insulin and carbohydrate regimen (number of units of insulin, number of carbohydrates, and/or ICR)
Long acting insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)
|
|---|---|---|
|
Caregiver Anxiety
Baseline
|
29.1 score on a scale
Interval 24.3 to 34.0
|
30.2 score on a scale
Interval 25.3 to 35.0
|
|
Caregiver Anxiety
1 month post-intervention
|
27.0 score on a scale
Interval 22.2 to 31.8
|
35.9 score on a scale
Interval 30.7 to 41.1
|
|
Caregiver Anxiety
4 months post-intervention
|
27.6 score on a scale
Interval 22.7 to 32.6
|
34.4 score on a scale
Interval 29.3 to 39.4
|
SECONDARY outcome
Timeframe: 1 month post-intervention, 4 months post-interventionThe GV was calculated in all subjects using the average blood glucose levels collected from the daily blood glucose paper log. A subjective qualification system was used to label each subject's GV based on their blood glucose levels and an established glucose monitoring (GM) data system. Subjects are considered to have appropriate GV if their blood glucose levels are in the range of 80 mg/dL - 180 mg/dL. Percentage of participants within each specific average BG range is shown.
Outcome measures
| Measure |
Fixed Group
n=12 Participants
Children and adolescents with newly-diagnosed T1DM will receive a fixed mealtime carbohydrate with a fixed mealtime insulin dose, that is a simplified regimen that provides a set amount of insulin for a set amount of carbohydrates, and ensures that each dose and each meal is consistent.
Rapid-Acting Insulin: Prior to discharge, all subjects will receive a regimen that includes a Meal-time insulin and carbohydrate regimen (number of units of insulin, number of carbohydrates, and/or ICR)
Long acting insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)
|
Insulin to Carbohydrate Ratio (ICR) Group
n=10 Participants
Children and adolescents with newly-diagnosed T1DM will receive an Insulin to carbohydrate ratio (ICR) with variable carbohydrate intake mealtime regimen
Rapid-Acting Insulin: Prior to discharge, all subjects will receive a regimen that includes a Meal-time insulin and carbohydrate regimen (number of units of insulin, number of carbohydrates, and/or ICR)
Long acting insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)
|
|---|---|---|
|
Glycemic Variability (GV) at 1 Month and 4 Months Post-intervention
BG < 50 mg/dL at 1 month post-intervention
|
0.5 percentage of participants
Interval 0.0 to 0.6
|
0.5 percentage of participants
Interval 0.0 to 0.7
|
|
Glycemic Variability (GV) at 1 Month and 4 Months Post-intervention
BG 50-79 mg/dL at 1 month post-intervention
|
8.9 percentage of participants
Interval 4.7 to 14.7
|
8.3 percentage of participants
Interval 5.2 to 10.0
|
|
Glycemic Variability (GV) at 1 Month and 4 Months Post-intervention
BG 80-180 mg/dL at 1 month post-intervention
|
67.5 percentage of participants
Interval 48.9 to 70.0
|
63.2 percentage of participants
Interval 54.0 to 74.6
|
|
Glycemic Variability (GV) at 1 Month and 4 Months Post-intervention
BG 181-350 mg/dL at 1 month post-intervention
|
25.8 percentage of participants
Interval 13.3 to 37.7
|
26.8 percentage of participants
Interval 17.1 to 34.0
|
|
Glycemic Variability (GV) at 1 Month and 4 Months Post-intervention
BG >350 mg/dL at 1 month post-intervention
|
0.8 percentage of participants
Interval 0.0 to 1.6
|
0.3 percentage of participants
Interval 0.0 to 2.0
|
|
Glycemic Variability (GV) at 1 Month and 4 Months Post-intervention
BG < 50 mg/dL at 4 month post-intervention
|
0.0 percentage of participants
Interval 0.0 to 0.2
|
0.4 percentage of participants
Interval 0.0 to 1.5
|
|
Glycemic Variability (GV) at 1 Month and 4 Months Post-intervention
BG 50-79 mg/dL at 4 month post-intervention
|
8.6 percentage of participants
Interval 5.3 to 12.4
|
7.3 percentage of participants
Interval 4.2 to 11.4
|
|
Glycemic Variability (GV) at 1 Month and 4 Months Post-intervention
BG 80-180 mg/dL at 4 month post-intervention
|
63.3 percentage of participants
Interval 57.1 to 80.4
|
69.0 percentage of participants
Interval 59.5 to 75.9
|
|
Glycemic Variability (GV) at 1 Month and 4 Months Post-intervention
BG 181-350 mg/dL at 4 month post-intervention
|
28.7 percentage of participants
Interval 8.2 to 35.5
|
21.8 percentage of participants
Interval 5.8 to 28.0
|
|
Glycemic Variability (GV) at 1 Month and 4 Months Post-intervention
BG >350 mg/dL at 4 month post-intervention
|
0.1 percentage of participants
Interval 0.0 to 0.8
|
0.4 percentage of participants
Interval 0.0 to 2.7
|
Adverse Events
Fixed Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Insulin to Carbohydrate Ratio (ICR) Group
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Fixed Group
n=12 participants at risk
Children and adolescents with newly-diagnosed T1DM will receive a fixed mealtime carbohydrate with a fixed mealtime insulin dose, that is a simplified regimen that provides a set amount of insulin for a set amount of carbohydrates, and ensures that each dose and each meal is consistent.
Rapid-Acting Insulin: Prior to discharge, all subjects will receive a regimen that includes a Meal-time insulin and carbohydrate regimen (number of units of insulin, number of carbohydrates, and/or ICR)
Long acting insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)
|
Insulin to Carbohydrate Ratio (ICR) Group
n=12 participants at risk
Children and adolescents with newly-diagnosed T1DM will receive an Insulin to carbohydrate ratio (ICR) with variable carbohydrate intake mealtime regimen
Rapid-Acting Insulin: Prior to discharge, all subjects will receive a regimen that includes a Meal-time insulin and carbohydrate regimen (number of units of insulin, number of carbohydrates, and/or ICR)
Long acting insulin: Prior to discharge, all subjects will receive a regimen that includes a daily dose of long-acting insulin (Glargine)
|
|---|---|---|
|
Metabolism and nutrition disorders
Severe Hypoglycemia
|
0.00%
0/12 • Data collected during follow up (until 4 months post-intervention).
|
0.00%
0/12 • Data collected during follow up (until 4 months post-intervention).
|
|
General disorders
Altered Mentas Status
|
0.00%
0/12 • Data collected during follow up (until 4 months post-intervention).
|
0.00%
0/12 • Data collected during follow up (until 4 months post-intervention).
|
|
Metabolism and nutrition disorders
Diabetic Keoacidosis
|
0.00%
0/12 • Data collected during follow up (until 4 months post-intervention).
|
0.00%
0/12 • Data collected during follow up (until 4 months post-intervention).
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place