Accuracy and Treatment Experience of Two Glucose Monitoring Systems Tested in Patients With Type 1 Diabetes and Renal Impairment

NCT03378271 | Completed

• 1 other identifier: CGM renal impairment
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The study aims to evaluate the accuracy of two commercial glucose monitoring systems in patients with type 1 or type 2 diabetes and renal impairment, including patients with or without dialysis. Patients treatment experience will even be evaluated.

Conditions

Diabetes Mellitus Complication; Renal Impairment

Keywords

Continuous Glucose Monitoring; Flash glucose Monitoring; Renal Impairment; Type 1 Diabetes; Type 2 Diabetes

Outcome Measures

Primary Outcomes (1)

• Accuracy of CGM and FGM

  Evaluation of accuracy in estimating capillary glucose levels of two commercial glucose monitoring systems (CGM and FGM), Dexcom G5 system (Dexcom sensor) and the Abbot Freestyle Libre sensor, in ambulatory patients with type 1 or type 2 diabetes and renal impairment with an eGFR\<30 ml/min both in and not in dialysis.

  The whole study period Day 1-14

Secondary Outcomes (4)

• The evaluation of the accuracy of the 2 glucose monitoring systems during each studied time interval (day 1-3 and day 4-6)

  Day 1-6 of study period

• The evaluation of the accuracy of the 2 glucose monitoring systems for various glucose intervals (hypo, normo- and hyperglycaemia)

  The whole study period Day 1-14

• The evaluation of the accuracy of the 2 glucose monitoring systems during dialysis and not in dialysis

  The whole study period Day 1-14

• The evaluation of patients preferences and experience of the two glucose monitoring systems.

  The whole study period Day 1-14

Study Arms (1)

FGM/CGM

EXPERIMENTAL

each patient will have a CGM and a FGM, subcutaneous glucose sensors, the data will be compared to the time-matched reference blood glucose measurements. Each ambulatory patient will sample capillary blood with the HemoCue meter and measure the concentration of glucose minimum 3 times per day for 14 days. The concentration of finger-stick capillary blood glucose will be measured using the self-monitoring blood glucose (SMBG) hemocue meter in their daily living. The subjects will record SMBG, in a written diary. Subjects will dose insulin according to their routine methods throughout the 14 day study

Device: Simultanious CGM/FGM

Interventions

Simultanious CGM/FGM DEVICE

Patients will use both CGM and FGM and document their values as well as documenting a capillary blood glucose value.

FGM/CGM

Eligibility Criteria

• Age: 18 Years - 79 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 1 or type 2 diabetes with renal impairment and eGFR \<30 ml/min measured within the last three months.
• Adult patients, age 18 or older and \<80 years.
• Written Informed Consent

You may not qualify if:

• Pregnancy
• Patients with severe cognitive dysfunction or other disease which makes glucose monitoring use difficult.
• Patients requiring continuous use of paracetamol. Paracetamol must not have been used the week before the study and shall not be used during the duration because it disturbs the interpretation of blood glucose levels estimated by the Dexcom G5. However, other pain killers can be used throughout the study period.
• Current CGM or FGM use.
• History of allergic reaction to any of the CGM or FGM materials or adhesives in contact with the skin.
• History of allergic reaction to chlorhexidine or alcohol anti-septic solution.
• Abnormal skin at the anticipated glucose sensor attachment sites (excessive hair, burn, inflammation, infection, rash, and/or tattoo).
• Patients with renal impairment and eGFR greater or equal to 30 ml/min estimated by the MDRD formula.

Sponsors & Collaborators

• Vastra Gotaland Region: lead

Study Sites (1)

NU-Hospital Group

Uddevalla, 45180, Sweden

Location

MeSH Terms

Conditions

Diabetes Complications; Renal Insufficiency; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Endocrine System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Marcus Lind, PhD

  Gothenburgh University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 11, 2017
• First Posted: December 19, 2017
• Study Start: May 5, 2016
• Primary Completion: December 30, 2019
• Study Completion: December 31, 2022
• Last Updated: February 29, 2024

Record last verified: 2024-02

Locations

SE (1)