Type 1 DiabetesGLADENCT05434559
Evaluation of Glycemic Control in Adults With Type 1 Diabetes When Switching to Insulin Degludec
An observational study of Type 1 Diabetes, run by prof dr Pieter Gillard at 2 sites in Belgium.
Trial summary
Retrospective multicenter study analyzing data gathered from medical records and diabetes management platforms to assess the effect of using Insulin Degludec (Tresiba®) on measures of diabetes control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Insulin Degludec
- How many people
- 475 participants
- Where
- 2 sitesBelgium
- Study dates
- 20 Feb 2022to 31 Oct 2022
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Every person who meet the inclusion criteria and who is/was followed at the two participating centers during the sampling period will be included in the analysis.
Who may be able to join
- People with T1D ≥18 years at the moment of switch to Insulin Degludec
- Diagnosed with T1D ≥2 years before switch to Insulin Degludec
- On basal-bolus insulin therapy with insulin pens ≥2 years before switch to Insulin Degludec
- ≥6 months use of Insulin Degludec at moment of datacollection
- Using continuous glucose monitoring ≥2 years before switch to Insulin Degludec
Who cannot join
- People with T1D <18 years at the moment of switch to Insulin Degludec
- People without T1D or with T1D <2 years before switch to Insulin Degludec
- Women with T1D who are pregnant or planning pregnancy during -12 and +12 months
- Not using basal-bolus insulin therapy with insulin pens during -24 and +6 months
- Start to use non-insulin antidiabetic agents between -12 and +12 months
- Having received treatment with oral or injectable corticosteroids during -12 and +12 months
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- Undergoing hemodialysis, renal transplantation, or beta cell transplantation during -12 and +12 months
- <6 months use of Insulin Degludec at moment of datacollection
- Not using continuous glucose monitoring or <2 years before switch to Insulin Degludec
Trial locations and contacts
2 sites in 1 country.
Belgium2 sites
Universitaire Ziekenhuizen Leuven
Leuven, 3000
University Hospital Antwerp
Wilrijk, 2650
About this study
Official title: Evaluation of Glycemic Control in Adults With Type 1 Diabetes When Switching to Insulin Degludec: a Retrospective Study
Retrospective multicenter study analyzing data gathered from medical records and diabetes management platforms to assess the effect of using Insulin Degludec (Tresiba®) on measures of diabetes control.
People with type 1 diabetes who switched to Insulin Degludec from another basal insulin between 1/5/2019 and 1/6/2021 will be included.
Glycemic control from 12 months before the switch to Insulin Degludec will be compared to glycemic control of the 12 months after the switch.
- Conditions
- Type 1 Diabetes
- Being tested
- Insulin Degludec
- Keywords
- Insulin Degludec, 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.
Insulin DegludecDrug
Switch during standard routine care to Insulin Degludec.
| Study group | Role | What they receive |
|---|---|---|
| Study cohort | People with type 1 diabetes who switched to Insulin Degludec from another basal insulin between 1/5/2019 and 1/6/2021 in the two participating sensors Receives: Drug: Insulin Degludec |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in range
the change in time in range (TIR: 70-180 mg/dL, averaged per month) over 24 hours between 12 (±2) months before switch to 12 (±2) months after switch to Insulin Degludec
Measured: 12 months
Secondary outcomes (10)
HbA1c
difference in HbA1c between 12 [±2] months before switch to 12 [±2] months after switch to Insulin Degludec
Measured: 12 months
Time below 54 mg/dL
difference in time in clinically significant hypoglycemia (<54 mg/dL averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am between 12 [±2] months before switch to 12 [±2] months after switch to Insulin Degludec
Measured: 12 months
Time in range
difference in TIR (70-180 mg/dL, averaged per month) from 6 am to 10 pm, and from 10 pm to 6 am between 12 [±2] months before switch to 12 [±2] months after switch to Insulin Degludec
Measured: 12 months
Time below 70 mg/dL
difference in time below range (<70 mg/dL averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am between 12 [±2] months before switch to 12 [±2] months after switch to Insulin Degludec
Measured: 12 months
Time above 180 mg/dL
difference in time above range (>180 mg/dL averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am between 12 [±2] months before switch to 12 [±2] months after switch to Insulin Degludec
Measured: 12 months
Time above 250 mg/dL
difference in time in significant hyperglycemia (>250 mg/dL averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am between 12 [±2] months before switch to 12 [±2] months after switch to Insulin Degludec
Measured: 12 months
Mean glucose
difference in mean glucose (averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am between 12 [±2] months before switch to 12 [±2] months after switch to Insulin Degludec
Measured: 12 months
Glycemic variability
difference in glycemic variability (standard deviation, coefficient of variation; averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am between 12 [±2] months before switch to 12 [±2] months after switch to Insulin Degludec
Measured: 12 months
Insulin dose
difference in insulin dose (total daily dose, basal dose, bolus dose) between 12 [±2] months before switch to 12 [±2] months after switch to Insulin Degludec
Measured: 12 months
Body mass index
difference in body mass index (BMI) between 12 [±2] months before switch to 12 [±2] months after switch to Insulin Degludec
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start20 Feb 2022
- Primary completion31 Oct 2022
- Study completion31 Oct 2022
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 Type 1 DiabetesStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 475 participants (actual)
Sponsor and investigators
- Lead sponsor
- prof dr Pieter Gillard
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Antwerp
- Responsible party
- Sponsor-investigator, prof dr Pieter Gillard, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05434559
- Sponsor's protocol ID
- S66239
- Acronym
- GLADE
- Status last verified
- Dec 2022
- First submitted
- 14 Jun 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
De Groote R, Lefever E, Charleer S, Donne P, De Block C, Mathieu C, Gillard P. Continuous Glucose Monitoring-Derived Glucometrics in Adults with Type 1 Diabetes When Switching Basal Insulins. Diabetes Technol Ther. 2024 Aug;26(8):587-595. doi: 10.1089/dia.2023.0616. Epub 2024 Apr 9.
PubMed 38512387
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Glycemic Control in Adults With Type 1 Diabetes When Switching to Insulin Degludec: a Retrospective Study
- ClinicalTrials.gov ID
- NCT05434559
- Acronym / sponsor ID
- GLADE / S66239
- Conditions
- Type 1 Diabetes
- Keywords
- Insulin Degludec, Continuous Glucose Monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 475 participants (actual)
- Lead sponsor
- prof dr Pieter GillardUniversity, hospital or other
- Collaborators
- University Hospital, Antwerp
- Study start
- 20 Feb 2022 (actual)
- Primary completion
- 31 Oct 2022 (actual)
- Study completion
- 31 Oct 2022 (actual)
- First posted
- 28 Jun 2022 (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.
Retrospective multicenter study analyzing data gathered from medical records and diabetes management platforms to assess the effect of using Insulin Degludec (Tresiba®) on measures of diabetes control.
People with type 1 diabetes who switched to Insulin Degludec from another basal insulin between 1/5/2019 and 1/6/2021 will be included.
Glycemic control from 12 months before the switch to Insulin Degludec will be compared to glycemic control of the 12 months after the switch.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study cohort | – | Drug: Insulin DegludecPeople with type 1 diabetes who switched to Insulin Degludec from another basal insulin between 1/5/2019 and 1/6/2021 in the two participating sensors |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Every person who meet the inclusion criteria and who is/was followed at the two participating centers during the sampling period will be included in the analysis.
Key inclusion criteria (5 listed)
- People with T1D ≥18 years at the moment of switch to Insulin Degludec
- Diagnosed with T1D ≥2 years before switch to Insulin Degludec
- On basal-bolus insulin therapy with insulin pens ≥2 years before switch to Insulin Degludec
- ≥6 months use of Insulin Degludec at moment of datacollection
- Using continuous glucose monitoring ≥2 years before switch to Insulin Degludec
Key exclusion criteria (9 listed)
- People with T1D <18 years at the moment of switch to Insulin Degludec
- People without T1D or with T1D <2 years before switch to Insulin Degludec
- Women with T1D who are pregnant or planning pregnancy during -12 and +12 months
- Not using basal-bolus insulin therapy with insulin pens during -24 and +6 months
- Start to use non-insulin antidiabetic agents between -12 and +12 months
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 |
|---|---|---|
| Insulin DegludecSwitch during standard routine care to Insulin Degludec. | Drug | Study cohort |
Primary outcome
Time in range
Time frame: 12 months
the change in time in range (TIR: 70-180 mg/dL, averaged per month) over 24 hours between 12 (±2) months before switch to 12 (±2) months after switch to Insulin Degludec
10 secondary outcomes
HbA1c
Time frame: 12 months
Time below 54 mg/dL
Time frame: 12 months
Time in range
Time frame: 12 months
Time below 70 mg/dL
Time frame: 12 months
Time above 180 mg/dL
Time frame: 12 months
Time above 250 mg/dL
Time frame: 12 months
Mean glucose
Time frame: 12 months
Glycemic variability
Time frame: 12 months
Insulin dose
Time frame: 12 months
Body mass index
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Derived from this study: PubMed 38512387De Groote R, Lefever E, Charleer S, Donne P, De Block C, Mathieu C, Gillard P. Continuous Glucose Monitoring-Derived Glucometrics in Adults with Type 1 Diabetes When Switching Basal Insulins. Diabetes Technol Ther. 2024 Aug;26(8):587-595. doi: 10.1089/dia.2023.0616. Epub 2024 Apr 9.
- Individual participant dataSharing planned: Undecided
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Type 1 Diabetes, run by prof dr Pieter Gillard at 2 sites in Belgium.
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 5 inclusion and 9 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: finished, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Belgium. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time in range (time frame: 12 months). 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 NCT05434559, 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 21 Dec 2022.