Diabetes Mellitus, Type 1
Conditions
Brief summary
Continuous Glucose Monitoring (CGM) systems improve glycaemic control in type 1 diabetic patients but they have different characteristics that could influence patients' quality of life and glycaemic control. In this randomized cross over study investigators will compare 2 different CGM systems: Eversense implantable sensor (Senseonics, Germantown, MD, USA) and the standard transcutaneous sensor Dexcom G5 (Dexcom, San Diego, CA, USA). Investigators will evaluate sensors' accuracy, impact on quality of life and efficacy in optimizing glycaemic control. The investigator's study's results might help clinicians choose the sensor and evaluate how sensor differences could impact glycaemic control.
Detailed description
Good glycaemic control in type 1 diabetic patients prevents the onset and progression of chronic complications. Continuous Glucose Monitoring (CGM) systems help patients improve glycaemic control by providing real-time glucose levels, glycaemic tendency, glycaemic swing rate and by alerting the patient when the glucose value read by the sensor reaches a predefined threshold of hyper or hypoglycaemia. Several CGM systems are available and they have different characteristics that could influence patients' quality of life and glycaemic control. In this randomized cross over study investigators will compare 2 different CGM systems: Eversense implantable sensor (Senseonics, Germantown, MD, USA) and the standard transcutaneous sensor Dexcom G5 (Dexcom, San Diego, CA, USA). Investigators will evaluate sensors' accuracy, impact on quality of life and efficacy in optimizing glycaemic control. Patients will use Dexcom G5 or Eversense for three months, respectively, in a randomized order. Accuracy will be evaluated comparing sensors values with capillary blood glucose at home. Quality of life will be assessed at the beginning and at the end of each three-month period through validated questionnaires to underline differences in different sensors use. Time spent in target (70-180 mg/dl), in hypoglycamiea and hyperglycemia will be evaluated with both sensors to assess differences in glycaemic control induced by different alarm system and by the presence of predictive alarms
Interventions
DEVICEDexcom G5-Eversense
Patients will wear sensor for 3 months, monitor blood capillary values 4 times/day. At the beginning and at the end of the period HbA1c will be measured and questionnaires will be administered
DEVICEEversense-Dexcom G5
Patients will wear sensor for 3 months, monitor blood capillary values 4 times/day. At the beginning and at the end of the period HbA1c will be measured and questionnaires will be administered. After 30-50 days of sensor implantation patients will wear also Dexcom G5 for a week to compare accuracy simultaneously
Sponsors
University of Padova
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male and female participants of at least 18 years of age * Diagnosis of type 1 diabetes mellitus (diagnosed according to World Health Organization criteria) for at least 1 year * Body Mass Index (BMI) \<35 kg / m² * Availability to wear study equipment and to comply with the study protocol for its entire duration * HbA1c \<10% * Signature of informed consent before any procedure related to the study.
Exclusion criteria
* Pregnancy, breastfeeding, intention to undergo pregnancy or refusal to use contraceptive methods during the study period (for female subjects). * Known allergies to skin patches or disinfectants used during the study. * Skin lesions, irritation, redness, edema in sites where sensors can be applied, as this might interfere with sensor's placement or with the accuracy of the glycaemic value detection. * Use of drugs that may interfere with glucose metabolism (such as steroids) unless they are chronic therapies whose dosage has remained stable over the past 3 months and is expected to remain stable during the study period. * Use of acetaminophen or other drugs that could influence sensor accuracy * Severe medical or psychological conditions, which, in the opinion of the medical team, may compromise patients' safety while participating in the study. * Patients enrolled in other clinical trials. * Known disorders of adrenal glands, pancreatic tumors or insulinoma * Patient's inability to comply with the procedures of the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| device accuracy | after 3 months, at the end of the study for each arm of the study | sensors' accuracy expressed in terms of MARD (mean absolute relative difference) versus capillary blood glucose in different glycaemic ranges |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HbA1c | after 3 months, at the end of the study for each arm of the study | HbA1c changes using different sensors, to evaluate sensor efficacy |
| failure | after 3 months, at the end of the study for each arm of the study | % Sensors' failure rate to evaluate sensor duration |
| Time spent in target | after 3 months, at the end of the study for each arm of the study | % Time spent in target (70-180 mg/dl) using each sensor to evaluate sensor efficacy |
| changes in quality of life | after 3 months, at the end of the study for each arm of the study | DTSQ questionnaire |
| changes in fear of hypoglycaemia | after 3 months, at the end of the study for each arm of the study | HFSII questionnaire |
| Adverse events | after 3 months, at the end of the study for each arm of the study | Adverse events (skin reactions, haematomas) |
Countries
Italy
Outcome results
None listed