Clinical trial NCT00564395: Detemir: Role in Type 1 Diabetes
Official title: Role of Insulin Aspart and Detemir to Assess Glucose Excursion in Children With Type 1 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Type 1 Diabetes Mellitus
Keywords: blood sugar
glycemic
Lead sponsor: Montefiore Medical Center
Sponsor class: OTHER
First posted: 2007-11-28
Enrollment: 18
Sex: ALL
Minimum age (years): 10
Maximum age (years): 25
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: 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
timeFrame: 0-48 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
city: Houston
country: United States
facility: Texas Children's Hospital Endocrine and Diabetes Clinic
state: Texas
Study officials:
affiliation: Baylor College of Medicine
name: Rubina A Heptulla, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nguyen TM, Renukuntla VS, Heptulla RA. Mixing insulin aspart with detemir does not affect glucose excursion in children with type 1 diabetes. Diabetes Care. 2010 Aug;33(8):1750-2. doi: 10.2337/dc10-0169. Epub 2010 May 26.