Type 1 Diabetes
Conditions
Keywords
post-prandial hyperglycemia
Brief summary
This study aims to compare the post-meal blood glucose values of two drugs in a real-world setting.
Detailed description
This is a randomized, open-label trial that aims to compare the glycemic excursion following food intake following post-meal injection of Glulisine (Apidra) insulin and Lispro (Humalog) insulin in a real-world setting. Children participating in the Florida Camp for Children and Youth with Diabetes will be randomized to receive either Glulisine or Apidra to cover carbohydrates after meals. The difference in blood glucose values will be analyzed before and 2 hours after meals to see if there is a difference in post-prandial hyperglycemia between groups.
Interventions
DRUGApidra
Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
DRUGHumalog
Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians.
DRUGNovolog
Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.)
Sponsors
Sanofi
University of Florida
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
9 Years to 14 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of type 1 Diabetes * Children and Youth attending Florida Diabetes Camp in DeLand, FL
Exclusion criteria
* only campers participating in sessions I and II are eligible to participate
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Lunch. | averaged over 5 days | Blood glucose concentrations were measured prior to and 90 minutes following lunch. Analysis was based on intention to treat. While missing data was imputed, it was known that this data was 'not missing at random' thus violating standard statistical assumptions with imputation. Therefore imputed data was not included in the final model. The number of participants for analysis was based upon a convenience sample of individuals attending Florida Camp for Children and Youth with Diabetes at Camp Winona. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Dinner | averaged over 5 days | Blood glucose concentrations were measured prior to and 120 minutes following dinner. Analysis was based on intention to treat. While missing data was imputed, it was known that this data was 'not missing at random' thus violating standard statistical assumptions with imputation. Therefore imputed data was not included in the final model. |
| Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Breakfast | averaged over 5 days | Blood glucose concentrations were measured prior to and 120 minutes following breakfast. Analysis was based on intention to treat. While missing data was imputed, it was known that this data was 'not missing at random' thus violating standard statistical assumptions with imputation. Therefore imputed data was not included in the final model. |
Countries
United States
Participant flow
Recruitment details
The study was conducted at the Florida Camp for Children & Youth with Diabetes during the summers of 2011 and 2012. In the summer of 2012 an additional arm was added to the study to include Novolog.
Pre-assignment details
There were 107 participants consented to the study. 8 participants were withdrawn prior to randomization to the study.
Participants by arm
| Arm | Count |
|---|---|
| Humalog Subjects on this treatment arm will receive Humalog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. | 41 |
| Apidra Subjects on this treatment arm will receive Apidra insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. | 40 |
| Novolog Subjects on this treatment arm will receive Novolog insulin for their bolus doses, with doses optimized individually to achieve glycemic targets at daily medical rounds with their cabin physicians. (NOTE: This arm was only for one year of the study which was the 2012 camp session.) | 18 |
| Total | 99 |
Baseline characteristics
| Characteristic | Humalog | Apidra | Novolog | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 41 Participants | 40 Participants | 18 Participants | 99 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment United States | 41 participants | 40 participants | 18 participants | 99 participants |
| Sex: Female, Male Female | 21 Participants | 21 Participants | 11 Participants | 53 Participants |
| Sex: Female, Male Male | 20 Participants | 19 Participants | 7 Participants | 46 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 41 / 41 | 40 / 40 | 18 / 18 |
| serious Total, serious adverse events | 0 / 41 | 0 / 40 | 0 / 18 |
Outcome results
Primary
The Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Lunch.
Blood glucose concentrations were measured prior to and 90 minutes following lunch. Analysis was based on intention to treat. While missing data was imputed, it was known that this data was 'not missing at random' thus violating standard statistical assumptions with imputation. Therefore imputed data was not included in the final model. The number of participants for analysis was based upon a convenience sample of individuals attending Florida Camp for Children and Youth with Diabetes at Camp Winona.
Time frame: averaged over 5 days
Population: Post-Prandial Blood Glucose Values \[Within 90 minutes following the completion of participant lunch\]
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humalog | The Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Lunch. | 146.69 mg/dl | Standard Deviation 79.19 |
| Apidra | The Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Lunch. | 143.68 mg/dl | Standard Deviation 79.48 |
| Novolog | The Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Lunch. | 149.02 mg/dl | Standard Deviation 71.56 |
p-value: 0.97195% CI: [129.73, 160.47]ANOVA
Secondary
Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Breakfast
Blood glucose concentrations were measured prior to and 120 minutes following breakfast. Analysis was based on intention to treat. While missing data was imputed, it was known that this data was 'not missing at random' thus violating standard statistical assumptions with imputation. Therefore imputed data was not included in the final model.
Time frame: averaged over 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humalog | Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Breakfast | 225.62 mg/dl | Standard Deviation 111.48 |
| Apidra | Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Breakfast | 225.46 mg/dl | Standard Deviation 81.14 |
| Novolog | Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Breakfast | 208.64 mg/dl | Standard Deviation 76.53 |
p-value: 0.80695% CI: [197.22, 243.71]ANOVA
Secondary
Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Dinner
Blood glucose concentrations were measured prior to and 120 minutes following dinner. Analysis was based on intention to treat. While missing data was imputed, it was known that this data was 'not missing at random' thus violating standard statistical assumptions with imputation. Therefore imputed data was not included in the final model.
Time frame: averaged over 5 days
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Humalog | Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Dinner | 170.57 mg/dl | Standard Deviation 50.54 |
| Apidra | Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Dinner | 160.96 mg/dl | Standard Deviation 73.54 |
| Novolog | Difference Between Pre- and 120 Minute Post-prandial Blood Glucose Concentrations at Dinner | 153.46 mg/dl | Standard Deviation 62.72 |
p-value: 0.69895% CI: [144.91, 177.28]ANOVA