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

26 mars 2020 uppdaterad av: Daniela Bruttomesso, University of Padova

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

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.

Studieöversikt

Status

Avslutad

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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

Studietyp

Interventionell

Inskrivning (Faktisk)

16

Fas

  • Inte tillämpbar

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Italien
      • Padova, Italien
        • University of Padova

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år och äldre (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Primärt syfte: Övrig
  • Tilldelning: Randomiserad
  • Interventionsmodell: Crossover tilldelning
  • Maskning: Ingen (Open Label)

Vapen och interventioner

Deltagargrupp / Arm
Intervention / Behandling
Aktiv komparator: 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
Enhet: 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
Experimentell: 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
Enhet: 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

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
device accuracy
Tidsram: 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
after 3 months, at the end of the study for each arm of the study

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Time spent in target
Tidsram: 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
after 3 months, at the end of the study for each arm of the study
HbA1c
Tidsram: after 3 months, at the end of the study for each arm of the study
HbA1c changes using different sensors, to evaluate sensor efficacy
after 3 months, at the end of the study for each arm of the study
failure
Tidsram: after 3 months, at the end of the study for each arm of the study
% Sensors' failure rate to evaluate sensor duration
after 3 months, at the end of the study for each arm of the study
Adverse events
Tidsram: after 3 months, at the end of the study for each arm of the study
Adverse events (skin reactions, haematomas)
after 3 months, at the end of the study for each arm of the study
changes in quality of life
Tidsram: after 3 months, at the end of the study for each arm of the study
DTSQ questionnaire
after 3 months, at the end of the study for each arm of the study
changes in fear of hypoglycaemia
Tidsram: after 3 months, at the end of the study for each arm of the study
HFSII questionnaire
after 3 months, at the end of the study for each arm of the study

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

University of Padova

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

14 mars 2018

Primärt slutförande (Faktisk)

31 december 2018

Avslutad studie (Faktisk)

1 september 2019

Studieregistreringsdatum

Först inskickad

26 april 2018

Först inskickad som uppfyllde QC-kriterierna

27 juli 2018

Första postat (Faktisk)

3 augusti 2018

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

27 mars 2020

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

26 mars 2020

Senast verifierad

1 mars 2020

Mer information

Termer relaterade till denna studie

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • 4270/AO/17

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

produkt tillverkad i och exporterad från U.S.A.

Nej

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