N/A
Completed N=153
Study of MiniMed™ 640G Insulin Pump With SmartGuard™ in Prevention of Low Glucose Events in Adults With Type 1 Diabetes
Source: ClinicalTrials.gov NCT02733991 ↗Enrolled (actual)
153
Serious AEs
4.6%
Results posted
Nov 2019
Primary outcomePrimary: Mean Number of Sensor Glucose Hypoglycaemic Events Below or Equal to 55 mg/dL Per Patient/Week. — 1.12; 4.13 hypoglycaemic events per week — p=<0.0001
Summary
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Mean Number of Sensor Glucose Hypoglycaemic Events Below or Equal to 55 mg/dL Per Patient/Week. |
1.12; 4.13 | <0.0001 sig |
| SECONDARY Mean Time Spent of Sensor Glucose Values Below or Equal 55 mg/dL. |
12.85; 60.08 | <0.0001 sig |
| SECONDARY Mean Time Spent of Sensor Glucose Values Within Range and Including 70-180 mg/dL. |
862.91; 832.18 | 0.0474 sig |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT02733991). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.