Clinical trial NCT02748122: CSII Pilot in Adolescents With Type 2 Diabetes
Official title: A Clinical Pilot to Assess Feasibility of Using Continuous Subcutaneous Insulin Injection Therapy (CSII: Insulin Pump) in Adolescents With Type 2 Diabetes (T2DM)
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Diabetes
Keywords: Adolescents
Insulin
T2DM
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
First posted: 2016-04-22
Enrollment: 6
Sex: ALL
Minimum age (years): 12
Maximum age (years): 23
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This feasibility pilot is intended to understand whether adolescents with Type 2 Diabetes (2DM) can be transitioned to a continuous subcutaneous insulin injection (CSII) and if so, assess whether CSII is a feasible treatment modality and improves quality of life (QOL) in adolescents with T2DM over 3 month period.


Eligibility criteria: Inclusion Criteria:

* Adolescents with Type 2 Diabetes mellitus between the ages of 12- 23 years, who have had T2DM for at least 6 month duration, and who have had a HbA1c \> 8% in the preceding 3 months prior to enrollment into the study. As a diabetes is a chronic disease the AAP (American Academy of Pediatrics; 2002) definition of a "Pediatric patient "is from birth until 21 years old. There are patients in the Diabetes program that we sometimes follow for 2-3 years beyond this age of 21 years and therefore would like to offer this study until the age of 23 years. This will give opportunity to our patients to be recruited if they would choose to participate in the study.
* Confirmed T2DM as defined by American Diabetes Association i.e. FPG \> 126 mg/dL or blood sugar \> 200 mg/dl on a 2 hr, 75 g OGTT or random blood sugar \>200 mg/dl. Pubertal, Tanner stage \>1
* Subjects must be willing to comply with study protocol requirements
* Females must have a negative pregnancy test within 72 hours prior to the start of the study and on every subsequent study visit. If on any visit their pregnancy test is positive they will be asked to not continue in the study. If the adolescent is using contraception such as birth control pills they will be allowed to continue using them during the study as this should not affect glucose levels. Once a female is confirmed to be pregnant we will take the insulin pump and restart insulin injection regimen that they were before the start of the study. We will also make an aptt with "high risk obstretics" and encourage the adolescent to check their blood sugars at least 4-6 times per day.
* The patient must be on insulin to qualify for the study. The adolescents could be on oral hypoglycemic agent in addition to insulin to be included in the study.

Exclusion Criteria:

* Chart review of adolescents with T2DM will be done to confirm absence of glutamic acid decarboxylase, islet cell or insulin autoantibodies or secondary causes of diabetes
* Other significant major organ system illness
* Females who are pregnant at their initial assessment. We will be testing female participants on every visit with a urine pregnancy test and if they are found to pregnant we will ask them to stop using their pump and go back to using insulin injections.
* Significant psychiatric illness: schizophrenia, bipolar disorder, active substance abuse and uncontrolled major depression.
* All adolescents who have signs of renal insufficiency (creatinine clearance based on Schwartz equation \>0.55 for females and males 0.7 ages 13-18 years) (13). Serum creatinine will be available on the metabolic profile. Subjects with elevated CrCl will be excluded from the study.

Primary outcomes:
measure: Change in score on Quality of Life questionnaire
timeFrame: Baseline and 3 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: New York University Langone Medical Center
state: New York
Study officials:
affiliation: NYU Langone Health
name: Preneet Brar, MD
role: PRINCIPAL_INVESTIGATOR
References: