CSII Pilot in Adolescents With Type 2 Diabetes

A Clinical Pilot to Assess Feasibility of Using Continuous Subcutaneous Insulin Injection Therapy (CSII: Insulin Pump) in Adolescents With Type 2 Diabetes (T2DM)

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.

Study Overview

• Status: Terminated
• Conditions: Diabetes
• Intervention / Treatment: Other: MMT 723

• Study Type: Interventional
• Enrollment (Actual): 6
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • New York University Langone Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 23 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Adolescents with T2DM	Other: MMT 723; Subjects will have the insulin pump inserted. With the aid of a small needle, the catheter (tube) of the insulin pump will be inserted through the skin into fatty tissue and will be taped in place. The subject will be required to wear the pump for three (3) months.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in score on Quality of Life questionnaire	Baseline and 3 months

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Preneet Brar, MD, NYU Langone Health

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (Actual): March 27, 2019
• Study Completion (Actual): March 27, 2019

Study Registration Dates

• First Submitted: April 19, 2016
• First Submitted That Met QC Criteria: April 21, 2016
• First Posted (Estimate): April 22, 2016

Study Record Updates

• Last Update Posted (Actual): September 17, 2019
• Last Update Submitted That Met QC Criteria: September 13, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: Adolescents; Insulin; T2DM
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus
• Other Study ID Numbers: 15-00313

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No