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Trial record 16 of 1486 for:    Type 1 Diabetes Mellitus 5

Eversense and Dexcom G5: Efficacy and Accuracy in Type 1 Diabetic Patients

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ClinicalTrials.gov Identifier: NCT03613805
Recruitment Status : Enrolling by invitation
First Posted : August 3, 2018
Last Update Posted : April 22, 2019
Sponsor:
Information provided by (Responsible Party):
Daniela Bruttomesso, University of Padova

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.


Condition or disease Intervention/treatment Phase
Diabetes Mellitus, Type 1 Device: Dexcom G5-Eversense Device: Eversense-Dexcom G5 Not Applicable

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


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Eversense and Dexcom G5 Comparison in Real Life: a Randomized Crossover Trial in Type 1 Diabetic Patients to Evaluate Differences in Accuracy, Efficacy and Quality of Life
Actual Study Start Date : March 14, 2018
Actual Primary Completion Date : December 31, 2018
Estimated Study Completion Date : September 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Dexcom G5 - Eversense
Patients will wear first Dexcom G5 (Dexcom San Diego, CA, USA) transcutaneous sensor for 3 months, then Eversnese(Senseonics Inc, MD, USA) implantable sensor for 3 months Accuracy and efficacy will be evaluated
Device: Dexcom 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

Experimental: Eversense- Dexcom G5
Patients will wear first Eversense (Senseonics Inc, MD, USA) implantable sensor for 3 months, then Dexcom G5 (Dexcom San Diego, CA, USA) transcutaneous sensor for 3 months accuracy and efficacy will be evaluated
Device: Eversense-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





Primary Outcome Measures :
  1. device accuracy [ Time Frame: 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 Outcome Measures :
  1. Time spent in target [ Time Frame: 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

  2. HbA1c [ Time Frame: after 3 months, at the end of the study for each arm of the study ]
    HbA1c changes using different sensors, to evaluate sensor efficacy

  3. failure [ Time Frame: after 3 months, at the end of the study for each arm of the study ]
    % Sensors' failure rate to evaluate sensor duration

  4. Adverse events [ Time Frame: after 3 months, at the end of the study for each arm of the study ]
    Adverse events (skin reactions, haematomas)

  5. changes in quality of life [ Time Frame: after 3 months, at the end of the study for each arm of the study ]
    DTSQ questionnaire

  6. changes in fear of hypoglycaemia [ Time Frame: after 3 months, at the end of the study for each arm of the study ]
    HFSII questionnaire



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03613805


Locations
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Italy
University of Padova
Padova, Italy
Sponsors and Collaborators
University of Padova

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Responsible Party: Daniela Bruttomesso, principal investigator, MD, PhD, Metabolic Unit, University of Padua, University of Padova
ClinicalTrials.gov Identifier: NCT03613805     History of Changes
Other Study ID Numbers: 4270/AO/17
First Posted: August 3, 2018    Key Record Dates
Last Update Posted: April 22, 2019
Last Verified: April 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Diabetes Mellitus, Type 1
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases