The isCGM Use and Hypoglycemic Episodes and Fear of Hypoglycemia in Newly Diagnosed Type 1 Diabetes (PENELOPE)

September 30, 2024 updated by: Jerzy Hohendorff, Jagiellonian University

The Impact of the isCGM Use on the Hypoglycemic Episodes and Fear of Hypoglycemia in Patients With Newly Diagnosed Type 1 Diabetes

The aim of this trial is to investigate the impact of FreeStyle Libre use compared to SMBG on hypoglycemia episodes and fear of hypoglycemia in adults aged 18-35 with newly diagnosed type 1 diabetes.

This trial is conducted in university centers in Poland (Bialystok, Krakow, Poznan, Zabrze).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Poland
      • Bialystok, Poland
        • Department of Endocrinology, Diabetology and Internal Medicine, Medical University of Bialystok
      • Krakow, Poland
        • Department of Metabolic Diseases, Jagiellonian University Medical College
      • Poznan, Poland
        • Department of Internal Medicine and Diabetology, Poznan University of Medical Sciences
      • Zabrze, Poland
        • Department of Internal Medicine, Diabetology, and Cardiometabolic Disorders, Medical University of Silesia in Katowice

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Newly diagnosed type 1 diabetes (diagnosed based on the WHO criteria) no later than 6 months after the diagnosis.
  • Insulin therapy: multiple daily injections,
  • In the investigator's opinion, the participant must be technically capable of using the FreeStyle Libre system

Exclusion Criteria:

  • Current or past use of any continuous glucose monitoring system.
  • Pump therapy.
  • Known allergy to medical adhesives.
  • Oral steroid therapy.
  • Pregnancy or planning pregnancy within the study duration.
  • Breast feeding.
  • Dialysis treatment.
  • Having a pacemaker.
  • Unstable coronary heart disease.
  • Cystic fibrosis.
  • Cancer.
  • Psychiatric disorders.
  • Severe end-organ damage (kidney, liver, etc) or any uncontrolled disorder.
  • Hospitalization for any reason other than the newly diagnosed type 1 diabetes 6 months prior to inclusion.
  • Participating in another clinical trial that could affect glucose measurements or glucose management.
  • In the investigator's opinion, if the participant is considered unsuitable for inclusion in the study for any other reason.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: FreeStyle Libre

FreeStyle Libre for 4 weeks.

All subjects will wear a masked sensor (FreeStyle Libre Pro) for 14 days prior to randomisation.
Device: Intermittently Scanned Continuous Glucose Monitoring
FreeStyle Libre, 4 weeks
Other Names:
  • FreeStyle Libre
Active Comparator: SMBG

Subjects randomised to the control group will monitor their blood glucose with standard blood glucose meters.

A 14-day FreeStyle Libre Pro is included for these subjects from day 14 to day 28 to collect glycaemic data for comparison to the intervention group of the study.

All subjects will wear a masked sensor (FreeStyle Libre Pro) for 14 days prior to randomisation.
Device: Standard Blood Glucose Monitoring
Standard blood glucose monitoring with glucose meters

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Hypoglycemia Fear Survey II
Time Frame: Baseline and day 28
Change in HFS II score from baseline to day 28
Baseline and day 28
TBR <70 mg/dL
Time Frame: Baseline and days 14 to 28
Difference in time <70 mg/dL between intervention and control group assessed in days 14 to 28
Baseline and days 14 to 28

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
TIR
Time Frame: Baseline and days 14 to 28
Difference in TIR 70-180 mg/dL between intervention and control group assessed in days 14 to 28
Baseline and days 14 to 28
TBR <54 mg/dL
Time Frame: Baseline and days 14 to 28
Difference in TBR <54 mg/dL between intervention and control group assessed in days 14 to 28
Baseline and days 14 to 28
TAR >180 mg/dl
Time Frame: Baseline and days 14 to 28
Difference in TAR >180 mg/dL between intervention and control group assessed in days 14 to 28
Baseline and days 14 to 28
TAR >250 mg/dl
Time Frame: Baseline and days 14 to 28
Difference in TAR >250 mg/dL between intervention and control group assessed in days 14 to 28
Baseline and days 14 to 28
DKA
Time Frame: Baseline to day 28
Difference in number of hospitalizations for diabetic ketoacidosis between intervention and control group
Baseline to day 28
Severe hypoglycemia
Time Frame: Baseline to day 28
Difference in number of severe hypoglycemia episodes between intervention and control group
Baseline to day 28
DDS
Time Frame: Baseline and day 28
Change in DDS score from baseline to day 28
Baseline and day 28
DTSQ
Time Frame: Baseline and day 28
Change in DTSQ score from baseline to day 28
Baseline and day 28
HFS II - Worry subscale
Time Frame: Baseline and day 28
Change in HFS II - worry subscale from baseline to day 28
Baseline and day 28
HFS II - Behaviour subscale
Time Frame: Baseline and day 28
Change in HFS II - behaviour subscale from baseline to day 28
Baseline and day 28

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Jagiellonian University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Diabetes Poland

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 10, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 10, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 16, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 30, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PENELOPE

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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