Detemir: Role in Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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)

Official Title
-----------------
Role of Insulin Aspart and Detemir to Assess Glucose Excursion in Children With Type 1 Diabetes

Conditions
-----------------
Type 1 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Insulin Detemir mixed with RAI injection
* Drug: Insulin Detemir and RAI injection


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 25 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin Detemir+RAI, then Insulin Detemir and RAI separately<br>Participants first received, Insulin Detemir mixed with RAI, twice daily as subcutaneous injection for 10 days. Then they received Insulin Detemir and RAI as separate subcutaneous injections, twice daily for the next 10 days. | Drug: Insulin Detemir mixed with RAI injection<br>* Insulin Detemir mixed with RAI injection is given twice daily as subcutaneous injection<br>|
| Active Comparator: Insulin Detemir and RAI separately, then Insulin Detemir+RAI<br>Participants first received Insulin Detemir and RAI as separate subcutaneous injections, twice daily for 10 days. Then they received Insulin Detemir mixed with RAI, twice daily as subcutaneous injection for the next 10 days. | Drug: Insulin Detemir and RAI injection<br>* Insulin detemir and RAI are given as separate injections, twice daily as subcutaneous injection<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the Mean Area Under the Curve (AUC) for Blood Glucose Concentration in Subjects Treated With Either Insulin Detemir Mixed With Rapid Acting Insulin (RAI) or Insulin Detemir and RAI as Separate Subcutaneous Injections | Blood glucose concentration in terms of mean AUC (0-48 hours)was determined in subjects treated with either Insulin Detemir mixed with RAI or Insulin Detemir and RAI as separate subcutaneous injections. | 0-48 hours post-dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
blood sugar, glycemic