Study of MiniMed™ 640G Insulin Pump With SmartGuard™ in Prevention of Low Glucose Events in Adults With Type 1 Diabetes

Study of MiniMed™ 640G Insulin Pump With SmartGuard™ in Prevention of Low Glucose Events in Adults With Type 1 Diabetes

A premarket, international multicenter, prospective, open label, adaptive, randomized controlled study.

The aim is to evaluate the efficacy of sensor augmented pump therapy with MiniMed™640G and SmartGuard™in preventing hypoglycemic events in comparison with continuous subcutaneous insulin infusion therapy in type 1 diabetes adults with an increased risk of hypoglycemia. The primary objective is to demonstrate a reduction in the mean number of hypoglycemic events when using the MiniMed™640G system with SmartGuard™ and the secondary objectives will aim at evaluating the difference in glycemic parameters and HbA1c.

Inclusion Criteria:

• Age 24-75 years old at time of screening.
• Diagnosed with Type 1 diabetes ≥10 years prior to screening.
• On pump therapy for ≥ 6 months prior to screening.
• Not on Real Time continuous glucose monitoring for ≥ 3 months prior to screening.
• HbA1c value ≥5.8% and ≤10.0% as assessed by local lab ≤ 15 days prior to screening or performed at screening.
• A documented Severe Hypoglycemia event ≤ 12 months prior to screening, OR Clarke score ≥4 assessed at time of screening, OR
• Gold score ≥4 assessed at time of screening.
• Subject is willing to sign and date informed consent, comply with all study procedures and wear all study devices as required during the study.

Exclusion Criteria:

• Untreated Addison's disease, thyroid disorder, growth hormone deficiency, hypopituitarism or definite gastroparesis, per investigator judgment.
• Subject is using Pramlintide (Symlin) SGLT2 inhibitor, GLP agonist at time of screening.
• Renal failure defined by creatinine clearance <30 ml/min, as assessed by local lab test ≤ 3 months before screening or performed at screening at local lab.
• Hearing or vision impairment hindering perception of glucose display and alarms, or otherwise incapable of using the study devices, per investigator judgment.
• Current pregnancy or intention to conceive.
• Any unresolved adverse skin condition in the area of sensor placement (e.g. psoriasis, rash, Staphylococcus infection).
• Alcohol or drug abuse, other than nicotine, per investigator judgment.
• Any other disease or condition that may preclude the patient from participating in the study, per investigator judgment.
• Legally incompetent, illiterate or vulnerable person.

Randomization Criteria:

• If subjects meet the above criteria, as well as all of the following criteria assessed at the end of the run-in period, they may continue to participate in the treatment period of the study:

  • Subject has worn two weeks the sensor with transmitter during the run-in period.
  • Subject has shown acceptable tolerance of sensor wear, per investigator judgment.
  • Subject performed ≥ 4 finger stick blood glucose measurements daily, as determined by CareLink™ Clinical data upload as the mean number of SMBG/day over the past 14 days (SMBG number / day ≥ 3.5 rounds up to 4).
  • Subject showed ability to comprehend the pump training and study procedures, per investigator judgment.