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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A | Other | Insulin pump naïve subjects with type 2 diabetes who are not achieving glycemic targets (screening A1C ≥ 7.0%) on an established regimen of ≥ 2 OAs |
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| B | Other | Insulin pump naïve subjects with type 2 diabetes who are not achieving glycemic targets (screening A1C ≥ 7.0%) on an established regimen of basal insulin ± OAs |
|
| C | Other | Insulin pump naïve subjects with type 2 diabetes who are not achieving glycemic targets (screening A1C ≥ 7.0%) on an established regimen basal-bolus insulin ± OAs |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin Pump therapy | Device | Initiation of Insulin pump therapy in patients on >2 OAs (Cohort A), basal insulin ± OAs (Cohort B), or basal-bolus insulin ± OAs (Cohort C. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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 | 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. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| A1C (Hemoglobin A1c) | To evaluate the effect of 16 weeks of insulin pump therapy in subjects with type 2 diabetes on glycemic outcome | Week 16 |
| 7 point profile | Self-monitored 7-point profiles were compared at baseline and Week 16 for each cohort and all cohorts combined. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Timothy Bailey, MD | AMCR Institute, Inc. | Principal Investigator |
| Bruce Bode, MD | Atlanta Diabetes Associates, Inc. | Principal Investigator |
| Mark Kipnes, MD | dgd Research, Inc. | Principal Investigator |
| John Liljenquist, MD | Rocky Mountain Diabetes and Osteoporosis Center, PA | Principal Investigator |
| Lyle Myers, M.D | Kentucky Diabetes Endocrinology Center | Principal Investigator |
| Sunder Mudaliar, MD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Regents of the University of California on behalf of its San Diego campus | La Jolla | California | 92093 | United States | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21355725 | Derived | Peyrot M, Rubin RR, Chen X, Frias JP. Associations between improved glucose control and patient-reported outcomes after initiation of insulin pump therapy in patients with type 2 diabetes mellitus. Diabetes Technol Ther. 2011 Apr;13(4):471-6. doi: 10.1089/dia.2010.0167. Epub 2011 Feb 28. | |
| 20879963 | Derived |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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 | End of study |
| Body Weight | Weight change was evaluated at Week 16 for each cohort and all cohorts combined. | 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. | 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) | Week 16 |
| AMCR Institute, Inc. |
| San Diego |
| California |
| 92026 |
| United States |
| Atlanta Diabetes Associates, Inc. | Atlanta | Georgia | 30309 | United States |
| Rocky Mountain Diabetes and Osteoporosis Center, PA | Idaho Falls | Idaho | 83404 | United States |
| Kentucky Diabetes Endocrinology Center | Lexington | Kentucky | 40503 | United States |
| dgd Research, Inc. | San Antonio | Texas | 78229 | United States |
| Rubin RR, Peyrot M, Chen X, Frias JP. Patient-reported outcomes from a 16-week open-label, multicenter study of insulin pump therapy in patients with type 2 diabetes mellitus. Diabetes Technol Ther. 2010 Nov;12(11):901-6. doi: 10.1089/dia.2010.0075. Epub 2010 Sep 30. |
| D004700 | Endocrine System Diseases |