Detemir: Role in Type 1 Diabetes
| Status: | Completed |
|---|---|
| Conditions: | Diabetes |
| Therapuetic Areas: | Endocrinology |
| Healthy: | No |
| Age Range: | 10 - 25 |
| Updated: | 7/19/2018 |
| Start Date: | August 2007 |
| End Date: | May 2010 |
Role of Insulin Aspart and Detemir to Assess Glucose Excursion in Children With Type 1 Diabetes
Study of blood sugars in the children with Type 1 Diabetes Mellitus (T1DM), who are given
insulin detemir and a rapid acting insulin (aspart). It is hypothesized that there is no
difference in the patterns of blood sugars when detemir is given in the same syringe or in
separate syringes with rapid acting insulin.
insulin detemir and a rapid acting insulin (aspart). It is hypothesized that there is no
difference in the patterns of blood sugars when detemir is given in the same syringe or in
separate syringes with rapid acting insulin.
One of the barriers to good glycemic control in children with type 1 diabetes is multiple
daily insulin injections. Mixing rapid-acting (detemir) and slow- acting insulins (aspart) in
the same syringe would decrease the number of injections and may improve adherence
This study hypothesized that slow-acting insulin detemir mixed with aspart would have
equivalent effects on blood glucose versus giving them as separate injections in children
with type 1 diabetes.
Eighteen pediatric subjects with type 1 diabetes (11 males and 7 females) were recruited.
However only 14 subjects completed this 20-day, randomized, crossover, and open-labeled
study. The subjects were randomly assigned to either Study A (both insulin detemir and rapid
acting insulin (RAI)) or Study B (either detemir or aspart) for the first 10 days. They were
then crossed over for the last 10 days. Each subject underwent 72 h of continuous glucose
monitoring (CGM) during the last 72 h, for both Study A and Study B.Data of 48 h from
midnight of the 1st day to mid- night of the 3rd day of the 72-h (CGM) were used for analysis
to ensure the same starting and ending times of monitoring for all subjects.Sustained glucose
values over time were calculated as area under the curve (AUC), index of blood glucose
control as M-value and glucose excursion as mean amplitude of glucose excursion (MAGE)
daily insulin injections. Mixing rapid-acting (detemir) and slow- acting insulins (aspart) in
the same syringe would decrease the number of injections and may improve adherence
This study hypothesized that slow-acting insulin detemir mixed with aspart would have
equivalent effects on blood glucose versus giving them as separate injections in children
with type 1 diabetes.
Eighteen pediatric subjects with type 1 diabetes (11 males and 7 females) were recruited.
However only 14 subjects completed this 20-day, randomized, crossover, and open-labeled
study. The subjects were randomly assigned to either Study A (both insulin detemir and rapid
acting insulin (RAI)) or Study B (either detemir or aspart) for the first 10 days. They were
then crossed over for the last 10 days. Each subject underwent 72 h of continuous glucose
monitoring (CGM) during the last 72 h, for both Study A and Study B.Data of 48 h from
midnight of the 1st day to mid- night of the 3rd day of the 72-h (CGM) were used for analysis
to ensure the same starting and ending times of monitoring for all subjects.Sustained glucose
values over time were calculated as area under the curve (AUC), index of blood glucose
control as M-value and glucose excursion as mean amplitude of glucose excursion (MAGE)
Inclusion Criteria:
- Subjects with antibody positive Type 1 Diabetes Mellitus (T1DM)
- On insulin glargine for at least 3 months
- Age 10-25 years
- Not on medications that may affect glucose concentrations
- Hemoglobin A1C (HbA1C) of less than 9 %
- Body Mass Index (BMI) less than 95th % and more than 10th%
- Supportive family
Exclusion Criteria:
- Subjects with undetermined diabetes or Type 2 Diabetes Mellitus (T2DM)
- Unable to adhere to insulin regimen
- Positive urine pregnancy test
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