16-week, open-label, multi-center pilot study. Insulin pump naïve subjects with type 2 diabetes who are not achieving glycemic targets (screening A1C ≥ 7.0%) on an established regimen of either: 1) ≥ 2 OAs (Cohort A), 2) basal insulin ± OAs (Cohort B), or 3) basal-bolus insulin ± OAs (Cohort C) will initiate basal-bolus therapy with an insulin pump using a rapid-acting insulin analog.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
58
Initiation of Insulin pump therapy in patients on \>2 OAs (Cohort A), basal insulin ± OAs (Cohort B), or basal-bolus insulin ± OAs (Cohort C.
The Regents of the University of California on behalf of its San Diego campus
La Jolla, California, United States
AMCR Institute, Inc.
San Diego, California, United States
Atlanta Diabetes Associates, Inc.
Atlanta, Georgia, United States
Rocky Mountain Diabetes and Osteoporosis Center, PA
Idaho Falls, Idaho, United States
Insulin doses at Week 16
To evaluate insulin doses after 16 weeks of insulin pump therapy aimed at achieving normal or near-normal glycemic control in subjects with type 2 diabetes.This included the total daily insulin dose, basal and bolus insulin doses.
Time frame: Week 16
Ratio of Basal-to-Bolus Insulin Dose at Week 16
Evaluate insulin dosing patterns after 16 weeks of insulin pump therapy aimed at safely achieving normal or near-normal glycemic control in patients with type 2 diabetes
Time frame: 16 weeks
Number of daily basal rates at Week 16
To evaluate insulin dosing patterns, i.e., number of daily basal rates, after 16 weeks of insulin pump therapy aimed at achieving normal or near-normal glycemic control in subjects with type 2 diabetes.
Time frame: Week 16
A1C (Hemoglobin A1c)
To evaluate the effect of 16 weeks of insulin pump therapy in subjects with type 2 diabetes on glycemic outcome
Time frame: Week 16
7 point profile
Self-monitored 7-point profiles were compared at baseline and Week 16 for each cohort and all cohorts combined.
Time frame: Week 16
CGM Glucose Ranges - Percent of Measurements
The percent of glucose values within the target range of 70-180 mg/dL, as measured by CGM
Time frame: End of study
Body Weight
Weight change was evaluated at Week 16 for each cohort and all cohorts combined.
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Kentucky Diabetes Endocrinology Center
Lexington, Kentucky, United States
dgd Research, Inc.
San Antonio, Texas, United States
Time frame: Week 16
Hypoglycemia
The incidence (percent of patients with at least one episode of hypoglycemia) of minor hypoglycemia was evaluated respectively. Minor hypoglycemia was defined as symptoms consistent with hypoglycemia that either resolved spontaneously or upon self-treatment with oral carbohydrate. Severe hypoglycemia referred to symptoms consistent with hypoglycemia during which the patient required the assistance of another individual and was associated with a documented glucose concentration less than 56 mg/dL or prompt recovery after oral carbohydrate, intravenous glucose, or glucagon.
Time frame: Week 16
Change from baseline to week 16 in Patient Reported Outcomes (PROs)
PROs were assessed at Baseline, Wk 8 (except for EQ-5D) and Wk 16, including EuroQol-5 Dimensions (EQ-5D) (Generic health-related QoL), Diabetes Symptom Checklist-Revised (DSC-R) (Diabetes-specific QoL), and Insulin Delivery System Rating Questionnaire (IDSRQ) (Treatment Satisfaction with insulin delivery system)
Time frame: Week 16