A Clinical Pilot to Assess Improvement in Health Related Quality of Life (QOL), Treatment Satisfaction, and Glycemic Control in Adolescents with Type 2 Diabetes (T2DM) Using Continuous Subcutaneous Insulin Injection Therapy (CSII)
Presentation Number: SUN 619
Date of Presentation: April 2nd, 2017
Preneet Cheema Brar*1, Elena Dingle2 and Daniela Ovadia3
1New York University School of Medicine, New York, NY, 2New York University School of Medicine, 3University of Texas Health Science Center, Houston, TX
Background: Treatment options for adolescents with Type 2 diabetes (T2DM) are limited to metformin and/or insulin (in adults there are >100 Rx options). Most adolescents with T2DM are in poor glycemic control 1. If this worrisome trend continues these adolescents, mostly of minority racial/ethnic groups, will have retinopathy, neuropathy and nephropathy in their twenties when compared to adults who are diagnosed with T2DM in their forties 2.
Objectives: Pilot study to investigate whether insulin pump therapy is a feasible treatment modality, improves quality of life (QOL) in adolescents with T2DM over a 3-month period. Pumps are considered appropriate, safe and efficacious by the American Diabetes Association in children with T1DM 3, though studies demonstrating their efficacy in adolescents with T2DM are lacking.
Method: In an open-label pilot (clinicaltrials.gov#02748122) adolescents with T2DM in poor control (HbA1c ≥ 8%) on insulin (0.5- 1.5 U/kg/day or more) and/or oral hypoglycemic agents were recruited. Adolescents were placed on a continuous glucose monitoring system (CGMS) before the pump start. At 1, 2 and 3 months pumps were downloaded and settings were titrated accordingly. Validated QOL questionnaires: the Pediatric Quality of Life Inventory (PedsQL: generic and diabetes modules), diabetes empowerment and treatment satisfaction scales were administered at the start and end of the pilot. Insulin pump MMT 723 and i-Pro2 professional, both made by Medtronic Inc., were used.
Results: Five female adolescents (mean ± SD: age: 16.3± 1.9 years; duration of diabetes: 5.4± 3 years; BMI: 30± 3) have completed the pilot. The total daily dose (TDD) of Lantus at the start of the study was 53±3 units. At the end of the pilot pump settings were as follows: basal rate: 1.4±0.4 U/hr; insulin carbohydrate ratio: 7±1 and insulin sensitivity factor: 23±7. The average blood sugars at the start and end of the pilot were: 205±91 and 161±70 mg/dl, respectively. The Hba1c at the start and end of the pilot were 11.7±1.4% and 10.3±1.8%, respectively. The acceptance was 40% with two adolescents opting to continue with insulin pumps for their ongoing diabetes management. Insulin requirements went down by 30% and the QOL parameters showed a trend to improvement.
Conclusions: At the end of the pilot HbA1c decreased by 1.3% which was significant. This result validates that insulin pumps when used by motivated adolescents improve glycemic control even over a short-term period. Teaching pump therapy to these technologically savvy adolescents was easy and adherence was fair (two subjects wore the pump 50% of the time of the study duration). Until more Rx options get approval insulin pumps may be an option to consider as more adolescents fail metformin and insulin injections and face enormous physical and psychological challenges of their poorly controlled T2DM.
Nothing to Disclose: PCB, ED, DO