Type 1 Diabetes
Conditions
Brief 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.
Interventions
DEVICEMiniMed™640G and Suspend before low
All enrolled subjects will start a run in phase, receive training and start pump therapy with the MiniMed™640G insulin pump and usage of blinded Continuous Glucose Monitoring. Eligible subjects that meet the randomization criteria assessed after the running phase will be randomized into the treatment or control arm. Treatment Arm: training and start of Sensor Augmented Pump therapy with Suspend before Low feature of SmartGuard turned ON. Control Arm: continuation of pump therapy alone with blinded continuous glucose monitoring for a total of 6 weeks during the treatment phase.
DEVICEMiniMed™640G
Control Arm: continuation of pump therapy alone with blinded continuous glucose monitoring for a total of 6 weeks.
Sponsors
Medtronic Diabetes
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
24 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean Number of Sensor Glucose Hypoglycaemic Events Below or Equal to 55 mg/dL Per Patient/Week. | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| Mean Time Spent of Sensor Glucose Values Below or Equal 55 mg/dL. | 6 months |
| Mean Time Spent of Sensor Glucose Values Within Range and Including 70-180 mg/dL. | 6 months |
Countries
France, Italy, Netherlands, United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment MiniMed™640G and Suspend before Low feature of SmartGuard™ turned on | 76 |
| Control MiniMed™640G alone | 77 |
| Total | 153 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 5 |
Baseline characteristics
| Characteristic | Treatment | Control | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 11 Participants | 7 Participants | 18 Participants |
| Age, Categorical Between 18 and 65 years | 65 Participants | 70 Participants | 135 Participants |
| Age, Continuous | 49 years STANDARD_DEVIATION 12.22 | 47.4 years STANDARD_DEVIATION 12.53 | 48.2 years STANDARD_DEVIATION 12.36 |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Region of Enrollment Canada | 12 participants | 12 participants | 24 participants |
| Region of Enrollment France | 14 participants | 16 participants | 30 participants |
| Region of Enrollment Italy | 19 participants | 20 participants | 39 participants |
| Region of Enrollment Netherlands | 15 participants | 15 participants | 30 participants |
| Region of Enrollment United Kingdom | 16 participants | 14 participants | 30 participants |
| Sex: Female, Male Female | 38 Participants | 38 Participants | 76 Participants |
| Sex: Female, Male Male | 38 Participants | 39 Participants | 77 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 76 | 0 / 77 |
| other Total, other adverse events | 36 / 76 | 37 / 77 |
| serious Total, serious adverse events | 6 / 76 | 1 / 77 |
Outcome results
Primary
Mean Number of Sensor Glucose Hypoglycaemic Events Below or Equal to 55 mg/dL Per Patient/Week.
Time frame: 6 months
Population: 2 participants in the control arm did not have data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Mean Number of Sensor Glucose Hypoglycaemic Events Below or Equal to 55 mg/dL Per Patient/Week. | 1.12 hypoglycaemic events per week | Standard Deviation 1.229 |
| Control | Mean Number of Sensor Glucose Hypoglycaemic Events Below or Equal to 55 mg/dL Per Patient/Week. | 4.13 hypoglycaemic events per week | Standard Deviation 3.361 |
p-value: <0.000195% CI: [-3.51, -2.25]Mixed Models Analysis
Secondary
Mean Time Spent of Sensor Glucose Values Below or Equal 55 mg/dL.
Time frame: 6 months
Population: 2 participants in the control arm did not have data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Mean Time Spent of Sensor Glucose Values Below or Equal 55 mg/dL. | 12.85 minutes per day | Standard Deviation 12.741 |
| Control | Mean Time Spent of Sensor Glucose Values Below or Equal 55 mg/dL. | 60.08 minutes per day | Standard Deviation 53.644 |
p-value: <0.000195% CI: [-52.01, -33.19]Mixed Models Analysis
Secondary
Mean Time Spent of Sensor Glucose Values Within Range and Including 70-180 mg/dL.
Time frame: 6 months
Population: 2 participants in the control arm did not have data.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Treatment | Mean Time Spent of Sensor Glucose Values Within Range and Including 70-180 mg/dL. | 862.91 minutes per day | Standard Deviation 162.91 |
| Control | Mean Time Spent of Sensor Glucose Values Within Range and Including 70-180 mg/dL. | 832.18 minutes per day | Standard Deviation 168.69 |
p-value: 0.047495% CI: [0.46, 77.11]Mixed Models Analysis