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Aspire in home study-hypo protection plan learning module

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hypo protection plan

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Aspire in home study-hypo protection plan learning module

  1. 1. Pump and CGM Clinical Data: the ASPIRE In-Home Study
  2. 2. Course Objectives This module shall empower you to:  Understand the ASPIRE In-Home Study objective, study design and results  Understand the ASPIRE In-Home conclusions and how they can be applied in everyday clinical practice
  3. 3. The ASPIRE In-Home Study The ASPIRE In-Home Study was published electronically ahead of print in the New England Journal of Medicine (June 2013) 3 | MDT Confidential and Proprietary; Do Not Copy or Distribute Bergenstal RM, Klonoff DC, Garg SK. E t al. N Engl J Med. June 22, 2013DOI: 10.1056 / NEJMoa1303576.
  4. 4. WHY IS IT IMPORTANT ? Hypoglycaemia is a major burden for many patients • Hypoglycaemia is a major barrier for patients to achieve good glucose control. • Hypoglycaemia can have severe consequences for patients (hospitalization) and does affect their quality of life • Fear of hypoglycaemia can affect adherence to therapy and lead to hyperglycaemia VEO + LGS is now clinically proven to significantly reduce hypoglycaemia versus SAP alone • There is good evidence that Pump therapy and SAP help reduce exposure to hypoglycaemia versus MDI. • ASPIRE In-Home study now provides evidence that the Low Glucose Suspend (LGS) feature of MiniMed VEO offers the potential to mitigate the risk of hypoglycaemia (number of events, duration and severity) versus SAP alone. ASPIRE In-Home : study primary outcome • The main objective of the ASPIRE In-Home Study is to evaluate the effect of MiniMed VEO with LGS activated vs. Sensor Augmented Pump (SAP) therapy on nocturnal hypoglycaemia and HbA1c in patients who experience nocturnal hypos.
  5. 5. The objective of ASPIRE In-Home Study The main objective of the study is to evaluate the effect of VEO + LGS versus SAP on: - nocturnal hypoglycaemia : “Is LGS effective at reducing hypo”? - and HbA1c : “Is LGS safe?” in patients who experience nocturnal hypos ( a ‘hypo-prone’ population)
  6. 6. Research & Study Design…. A randomised controlled multicenter parallel study  Randomized, controlled multicenter trial over a 3 month period: comparing how glucose control is when the patient has the LGS ON compared to when a subject has only sensor ON  There was a pre-study period to assess if subjects experienced nocturnal hypoglycaemia  Patients were randomized to one of 2 treatment paths: : – Those who have the sensor ON for 3 months and activate the LGS feature. – Those who have the sensor ON for 3 months without the LGS feature HbA1c was measured and glycaemic parameters were collected Patient population included: – 247 adults and teens (aged 16-70 years) with Type 1 diabetes in 19 centers in the USA.
  7. 7. Research & Study Design….  The Run-In phase was performed to ensure that the study population was experiencing night-time hypoglycaemia  The two randomised arms were well matched for age, duration of diabetes and HbA1c.
  8. 8. RESULTS – EFFICACY OF LGS LGS reduces the duration and severity (AUC) of hypos The mean area under the curve (AUC) can be used to represent the duration and severity of hypoglycaemia. Nocturnal Mean AUC (mg/dL*min) 38% reduction, p<0.01 1600 Results of the ASPIRE In-Home Study show that: - Nocturnal hypoglycaemia represented as Mean Area Under the Curve (AUC) was significantly reduced by 38% when LGS was used 1400 1200 1000 800 600 - 24 hours AUC was also significantly reduced 400 200 0 LGS ON Baseline SAP Study
  9. 9. RESULTS – EFFICACY OF LGS LGS reduces the frequency of hypo events at night The use of LGS reduced the frequency of nocturnal hypoglycaemia events - There was 31.8% decrease in the hypo events when LGS was used during the night
  10. 10. RESULTS – EFFICACY OF LGS reduces the frequency of hypo events throughout the full 24 hours. The study protocol dictated that subjects had to use LGS during the overnight period. However subjects were encouraged to use LGS during the day. - Even though many patients are more able to respond to their symptoms during the day; there was still a significant reduction in the frequency of hypo events. LGS reduces the number of hypoglycaemia events # Hypo events 6 per patient-week 5 32% reduction p<0.01 30% reduction p<0.01 4 3 2 - There was 30% decrease in the hypo events when LGS was used during the full 24 hours. 1 Baseline Study - 0 LGS ON SAP NIGHT TIME LGS ON SAP Strictly Confidential | 10 DAY + NIGHT
  11. 11. RESULTS – EFFICACY OF LGS LGS reduces mild, moderate and severe hypos The LGS threshold was set to 70 mg/dl for the study. However, minimizing time in the hypo range also resulted in a reduction of the number of values in the more ‘severe’ hypo ranges, those values below 60mg/dl and below 50 mg/dl.
  12. 12. RESULTS – SAFETY OF LGS LGS did not cause any significant rebound hyperglycaemia
  13. 13. RESULTS – SAFETY OF LGS LGS does not cause HbA1c increase Use of the LGS feature, and the repeated stopping of insulin during hypo events cause any deterioration of the HbA1c over the 3 month period. Glucose measurements 4 hours after LGS activation were still within acceptable targets. LGS Active Glucose (mean±SD ) 2h post-suspend (at insulin resume 92.6 ± 40.7 mg/dL 2h post-resume (4h after LGS enabled) 168.8 ± 64.6 mg/dL. There were no severe hypo events in the LGS group, but there were 4 events in the control group. Neither group reported any DKA events.
  14. 14. CONCLUSION – WHAT’S IN IT FOR THE HCPs?  Patients who experience hypoglycaemia can significantly reduce their hypoglycemia, safely, without increasing HbA1c levels.  Use of the LGS feature reduced the weekly rate of hypoglycemic events, suggesting that it prevented hypoglycemia.  Automating insulin delivery, using sensor-augmented pump therapy is an important strategy to reduce hypoglycaemia.
  15. 15. Why are these results important? Hypoglycemia causes significant clinical and economic burden to the health care system. From a clinical perspective, hypoglycemic episodes can lead to a vicious cycle of recurrent hypoglycemia which increases the risk of severe hypoglycemia and the development of hypoglycemia unawareness and hypoglycemia-associated autonomic failure (HAAF). Avoiding hypoglycemia can improve one’s awareness of (and may help avoid) future hypoglycemia. The ASPIRE-In Home study proves that MiniMed sensor integrated pump system with automated suspension can reduce hypoglycemia and be an important solution in reducing the clinical and economic burden associated with hypoglycemia.