Long-term, Implantable Sensor Improves Health Outcomes in Patients With T1D

NCT04160156 | Completed FDA Device

• 1 other identifier: Long term implantable sensor
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

The implantable Eversense ® CGM System obtained CE marking in 2016 for the 90-day device and in 2017 for the 180-day device.There is interest in real-world clinical evidence on the use of Eversense regarding changes in HbA1c and time in range (TIR), time below range (TBR), and time above range (TAR) in patients with type 1 diabetes. This is a prospective, multi-center, observational clinical study among adult participants aged 18 years or older with T1D and Eversense CGM System-naïve aimed to evaluate the change in HbA1c and glucometric parameters (TIR, TAR, TBR, mean daily glucose and standard deviation) in patients with T1D from multiple clinics in Italy using the Eversense CGM System for a 6-month time period.

Conditions

Diabetes Mellitus, Type 1

Keywords

Continuous glucose monitoring; sensor; glycated hemoglobin; Time in range

Outcome Measures

Primary Outcomes (6)

• HbA1c (%)

  Measured by High Performance Liquid Chromatography

  six months

• Time in Range (%)

  Collection from diabetes management system

  six months

• Time Below Range (%)

  Collection from diabetes management system

  six months

• Time Above Range (%)

  Collection from diabetes management system

  six months

• Mean Daily Glucose (mmol/l)

  Collection from diabetes management system

  six months

• Glucose Standard Deviation (mmol/L)

  Collection from diabetes management system

  six months

Study Arms (1)

Type 1 diabetes

Subjects attending metabolic clinic who were suggested to use long term sensor due to persistent hyperglycemia and hypoglycemia

Device: Long term sensor

Interventions

Long term sensor DEVICE

Observational study including subjects using long term sensor according to local guidelines and patients preferences

Type 1 diabetes

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants aged 18 years or older who were suggested to wear long term sensor.

You may qualify if:

• Type 1 diabetes
• Age \>18 years
• Eversense ® CGM System-naïve

You may not qualify if:

• candidates for a MRI during sensor wear
• critically ill including hospitalization
• known contradiction to dexamethasone
• required intravenous mannitol or mannitol irrigation solutions
• pregnancy

Sponsors & Collaborators

• University Magna Graecia: lead

Study Sites (1)

University Magna Graecia

Catanzaro, 88100, Italy

Location

Related Publications (1)

• Irace C, Cutruzzola A, Nuzzi A, Assaloni R, Brunato B, Pitocco D, Tartaglione L, Di Molfetta S, Cignarelli A, Laviola L, Citro G, Lovati E, Gnasso A, Tweden KS, Kaufman FR. Clinical use of a 180-day implantable glucose sensor improves glycated haemoglobin and time in range in patients with type 1 diabetes. Diabetes Obes Metab. 2020 Jul;22(7):1056-1061. doi: 10.1111/dom.13993. Epub 2020 Feb 27.

  PMID: 32037699 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 7, 2019
• First Posted: November 12, 2019
• Study Start: June 5, 2018
• Primary Completion: June 30, 2019
• Study Completion: June 30, 2019
• Last Updated: November 12, 2019

Record last verified: 2019-11

Locations

IT (1)