Diabetes Mellitus, Type 1PENELOPENCT06414824
The isCGM Use and Hypoglycemic Episodes and Fear of Hypoglycemia in Newly Diagnosed Type 1 Diabetes
A study testing Intermittently Scanned Continuous Glucose Monitoring and Standard Blood Glucose Monitoring in people with Diabetes Mellitus, Type 1, run by Jagiellonian University at 4 sites in Poland.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 to 35 years
- Conditions the study is for
- Diabetes Mellitus, Type 1
- What is being tested?
- Intermittently Scanned Continuous Glucose Monitoring and Standard Blood Glucose Monitoring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 4 sitesPoland
- Study dates
- 1 May 2022to 31 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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.
Trial locations and contacts
4 sites in 1 country.
Poland4 sites
Department of Endocrinology, Diabetology and Internal Medicine, Medical University of Bialystok
Bialystok
Department of Metabolic Diseases, Jagiellonian University Medical College
Krakow
Department of Internal Medicine and Diabetology, Poznan University of Medical Sciences
Poznan
Department of Internal Medicine, Diabetology, and Cardiometabolic Disorders, Medical University of Silesia in Katowice
Zabrze
About this study
Official title: 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).
- Conditions
- Diabetes Mellitus, Type 1
- Being tested
- Intermittently Scanned Continuous Glucose Monitoring, Standard Blood Glucose Monitoring
- Keywords
- ambulatory glucose profile, time in range, fear of hypoglycemia, continuous glucose monitoring
- Medical subject headings
- Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intermittently Scanned Continuous Glucose MonitoringDevice
Also called FreeStyle Libre
FreeStyle Libre, 4 weeks
Standard Blood Glucose MonitoringDevice
Standard blood glucose monitoring with glucose meters
| Study group | Role | What they receive |
|---|---|---|
| FreeStyle Libre | Experimental | FreeStyle Libre for 4 weeks.
All subjects will wear a masked sensor (FreeStyle Libre Pro) for 14 days prior to randomisation. Receives: Device: Intermittently Scanned Continuous Glucose Monitoring |
| SMBG | Active comparator | 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. Receives: Device: Standard Blood Glucose Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hypoglycemia Fear Survey II
Change in HFS II score from baseline to day 28
Measured: Baseline and day 28
TBR <70 mg/dL
Difference in time <70 mg/dL between intervention and control group assessed in days 14 to 28
Measured: Baseline and days 14 to 28
Secondary outcomes (10)
TIR
Difference in TIR 70-180 mg/dL between intervention and control group assessed in days 14 to 28
Measured: Baseline and days 14 to 28
TBR <54 mg/dL
Difference in TBR <54 mg/dL between intervention and control group assessed in days 14 to 28
Measured: Baseline and days 14 to 28
TAR >180 mg/dl
Difference in TAR >180 mg/dL between intervention and control group assessed in days 14 to 28
Measured: Baseline and days 14 to 28
TAR >250 mg/dl
Difference in TAR >250 mg/dL between intervention and control group assessed in days 14 to 28
Measured: Baseline and days 14 to 28
DKA
Difference in number of hospitalizations for diabetic ketoacidosis between intervention and control group
Measured: Baseline to day 28
Severe hypoglycemia
Difference in number of severe hypoglycemia episodes between intervention and control group
Measured: Baseline to day 28
DDS
Change in DDS score from baseline to day 28
Measured: Baseline and day 28
DTSQ
Change in DTSQ score from baseline to day 28
Measured: Baseline and day 28
HFS II - Worry subscale
Change in HFS II - worry subscale from baseline to day 28
Measured: Baseline and day 28
HFS II - Behaviour subscale
Change in HFS II - behaviour subscale from baseline to day 28
Measured: Baseline and day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 May 2022
- Primary completion31 Dec 2023
- Study completion31 May 2024
Why it stopped: The study ended early due to CGM reimbursement policy changes, after that most patients eligible for the study could have isCGM reimbursed.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jagiellonian University
- Sponsor type
- University, hospital or other
- Collaborators
- Diabetes Poland
- Responsible party
- Principal investigator, Jerzy Hohendorff, Jagiellonian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06414824
- Sponsor's protocol ID
- PENELOPE
- Acronym
- PENELOPE
- Status last verified
- Sep 2024
- First submitted
- 10 May 2024
- Last updated
- 2 Oct 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Hohendorff J, Grzelka-Wozniak A, Wrobel M, Kania M, Lapinska L, Rokicka D, Stoltny D, Kowalska I, Strojek K, Zozulinska-Ziolkiewicz D, Malecki MT. Impact of the initiation of isCGM soon after type 1 diabetes mellitus diagnosis in adults on glycemic indices and fear of hypoglycemia: a randomized controlled trial. Front Endocrinol (Lausanne). 2025 Jan 9;15:1503891. doi: 10.3389/fendo.2024.1503891. eCollection 2024.
PubMed 39850477
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the isCGM Use on the Hypoglycemic Episodes and Fear of Hypoglycemia in Patients With Newly Diagnosed Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT06414824
- Acronym / sponsor ID
- PENELOPE / PENELOPE
- Conditions
- Diabetes Mellitus, Type 1
- Keywords
- ambulatory glucose profile, time in range, fear of hypoglycemia, continuous glucose monitoring
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study ended early due to CGM reimbursement policy changes, after that most patients eligible for the study could have isCGM reimbursed.
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Jagiellonian UniversityUniversity, hospital or other
- Collaborators
- Diabetes Poland
- Study start
- 1 May 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 31 May 2024 (actual)
- First posted
- 16 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FreeStyle Libre | Experimental | Device: Intermittently Scanned Continuous Glucose MonitoringFreeStyle Libre for 4 weeks. All subjects will wear a masked sensor (FreeStyle Libre Pro) for 14 days prior to randomisation. |
| SMBG | Active comparator | Device: Standard Blood Glucose MonitoringSubjects 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intermittently Scanned Continuous Glucose MonitoringAlso: FreeStyle LibreFreeStyle Libre, 4 weeks | Device | FreeStyle Libre |
| Standard Blood Glucose MonitoringStandard blood glucose monitoring with glucose meters | Device | SMBG |
Primary outcome
Hypoglycemia Fear Survey II
Time frame: Baseline and day 28
Change in HFS II score from baseline to 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
10 secondary outcomes
TIR
Time frame: Baseline and days 14 to 28
TBR <54 mg/dL
Time frame: Baseline and days 14 to 28
TAR >180 mg/dl
Time frame: Baseline and days 14 to 28
TAR >250 mg/dl
Time frame: Baseline and days 14 to 28
DKA
Time frame: Baseline to day 28
Severe hypoglycemia
Time frame: Baseline to day 28
DDS
Time frame: Baseline and day 28
DTSQ
Time frame: Baseline and day 28
HFS II - Worry subscale
Time frame: Baseline and day 28
HFS II - Behaviour subscale
Time frame: Baseline and day 28
Results and safety
The study was stopped early (reason given: The study ended early due to CGM reimbursement policy changes, after that most patients eligible for the study could have isCGM reimbursed.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2024.
- Derived from this study: PubMed 39850477Hohendorff J, Grzelka-Wozniak A, Wrobel M, Kania M, Lapinska L, Rokicka D, Stoltny D, Kowalska I, Strojek K, Zozulinska-Ziolkiewicz D, Malecki MT. Impact of the initiation of isCGM soon after type 1 diabetes mellitus diagnosis in adults on glycemic indices and fear of hypoglycemia: a randomized controlled trial. Front Endocrinol (Lausanne). 2025 Jan 9;15:1503891. doi: 10.3389/fendo.2024.1503891. eCollection 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intermittently Scanned Continuous Glucose Monitoring and Standard Blood Glucose Monitoring in people with Diabetes Mellitus, Type 1, run by Jagiellonian University at 4 sites in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 2 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: The study ended early due to CGM reimbursement policy changes, after that most patients eligible for the study could have isCGM reimbursed.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hypoglycemia Fear Survey II (time frame: Baseline and day 28). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06414824, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2024.