Type 1 DiabetesFUTURE-GLARENCT05109520
Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL
An observational study of Type 1 Diabetes, run by prof dr Pieter Gillard at 3 sites in Belgium.
Trial summary
Retrospective multicenter study analyzing data gathered during the FUTURE study (S59342) to assess the effect of using Insulin Glargine 300 U/mL (Gla-300) on measures of diabetes control and quality of life. Of the FUTURE participants, data about the type of insulin the participants used will be gathered. 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 Glargine 300 UNT/ML [Toujeo]
- How many people
- 867 participants
- Where
- 3 sitesBelgium
- Study dates
- 8 Sep 2021to 14 Oct 2021
- 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: People with type 1 diabetes who participated in the FUTURE study.
Who may be able to join
- participant in the FUTURE study
- diagnosed with type 1 diabetes ≥3 months before start of the FUTURE study
- use of insulin pens for the entirety of the FUTURE study
- used Insulin Detemir (Levemir®), Insulin Glargine 100 U/mL (Lantus®) or an equivalent as basal insulin before switch to Gla-300 (Toujeo®)
- switched to Gla-300 (Toujeo®) during the FUTURE study for a sufficient amount of time (at least two consecutive diabetes consultations = 8 months)
- participant in the FUTURE study for at least 18 months
Show all 9Show fewer
- diagnosed with type 1 diabetes ≥3 months before start of the FUTURE study
- use of insulin pens for the entirety of the FUTURE study
- use Insulin Detemir (Levemir®), Insulin Glargine 100 U/mL (Lantus®) or an equivalent as basal insulin during the entirety of the FUTURE study
Who cannot join
- use of Fast-acting insulin aspart (Fiasp®) before or after switch to Gla-300
- not using bolus insulin (only basal insulin)
- for women: pregnant or planning pregnancy during the FUTURE study
- Control group
- use of Fast-acting insulin aspart (Fiasp®)
- not using bolus insulin (only basal insulin)
- for women: pregnant or planning pregnancy during the FUTURE study
- switch to Gla-300 (Toujeo®) or Insulin Degludec (Tresiba®) before 18 months in FUTURE study (if switched after 18 months, only data up to switch to Gla-300 [Toujeo®] or Insulin Degludec [Tresiba®] will be used for this control participant)
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
Onze Lieve Vrouw Ziekenhuis Aalst
Aalst, 9300
Universitair Ziekenhuis Antwerpen
Edegem, 2650
Universitaire Ziekenhuizen Leuven
Leuven, 3000
About this study
Official title: Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL: A FUTURE Substudy
Retrospective multicenter study analyzing data gathered during the FUTURE study (S59342) to assess the effect of using Insulin Glargine 300 U/mL (Gla-300) on measures of diabetes control and quality of life.
Of the FUTURE participants, data about the type of insulin the participants used will be gathered. On the basis of these data participants will be divided in two groups (control or investigational).
Read more
Change in glycemic control and quality of life from before to after the switch to Gla-300 (investigational group) will be compared to the change of glycemic control and quality of life of the FUTURE participants who did not switch to Gla-300 (control group).
The FUTURE study was a 24-month during multicenter observational cohort study analyzing data on the use of the Abbott Freestyle Libre in people with diabetes. Data were gathered during standard clinical follow-up, and from questionnaires that were presented to the participants at defined time points.
- Conditions
- Type 1 Diabetes
- Being tested
- Insulin Glargine 300 UNT/ML [Toujeo]
- Keywords
- Insulin Glargine 300 U/mL, 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 Glargine 300 UNT/ML [Toujeo]Drug
Switch during standard routine care to Gla-300.
| Study group | Role | What they receive |
|---|---|---|
| investigational group | Participants of the FUTURE study who switched during the study to Gla-300 Receives: Drug: Insulin Glargine 300 UNT/ML [Toujeo] | |
| control group | Participants of the FUTURE study who did not switch to Insulin Gla-300 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time in range (TIR, 70-180 mg/dL)
The difference in evolution of TIR (70-180 mg/dL, averaged per month) over 24 hours since switch to Gla-300
Measured: maximum 24 months
Secondary outcomes (10)
HbA1c
difference in HbA1c
Measured: maximum 24 months
Time in range (TIR, 70-180 mg/dL)
difference in TIR (70-180 mg/dL, averaged per month) from 6 am to 10 pm, and from 10 pm to 6 am
Measured: maximum 24 months
Hypoglycemia
difference in time in hypoglycemia (<54 mg/dL, <70 mg/dL, ≥54-<70 mg/dL; averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am
Measured: maximum 24 months
Hyperglycemia
difference in time in hyperglycemia (>180 mg/dL, >250 mg/dL, >180-≤250 mg/dL; averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am
Measured: maximum 24 months
Mean glycemia
difference in mean glucose (averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am
Measured: maximum 24 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
Measured: maximum 24 months
Quality of life measured by the Short Form Health Survey 36-item (SF-36) version 2 questionnaire
Quality of life measured by the Short Form Health Survey 36-item (SF-36) version 2 questionnaire (scale: 0 (low quality of life) - 100 (high quality of life))
Measured: maximum 24 months
Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry
Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry (scale: 0 (not worried) - 72 (very worried))
Measured: maximum 24 months
Distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire
Distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire (scale: 0 (no distress) - 20 (very distressed))
Measured: maximum 24 months
Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire, status (DTSQs)
Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire, status (DTSQs) (scale: 0 (low satisfaction) - 36 (high satisfaction))
Measured: maximum 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start8 Sep 2021
- Primary completion14 Oct 2021
- Study completion14 Oct 2021
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
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 867 participants (actual)
Sponsor and investigators
- Lead sponsor
- prof dr Pieter Gillard
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Antwerp, Onze Lieve Vrouw Hospital
- Responsible party
- Sponsor-investigator, prof dr Pieter Gillard, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Pieter Gillard, MD, PhD, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109520
- Sponsor's protocol ID
- S65399
- Acronym
- FUTURE-GLARE
- Status last verified
- Aug 2022
- First submitted
- 14 Oct 2021
- Last updated
- 30 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD can be shared upon a genuine request.
Publications
Charleer S, Fieuws S, De Block C, Bolsens N, Nobels F, Mikkelsen K, Mathieu C, Gillard P. Evaluation of Glucose Metrics in Adults with Type 1 Diabetes Switching to Insulin Glargine 300 U/mL: A Retrospective, Propensity-Score Matched Study. Diabetes Technol Ther. 2024 Jul;26(7):488-493. doi: 10.1089/dia.2023.0371. Epub 2024 Mar 6.
PubMed 38386438
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Glycemic Control and Quality of Life in Adults With Type 1 Diabetes During Continuous Glucose Monitoring When Switching to Insulin Glargine 300 U/mL: A FUTURE Substudy
- ClinicalTrials.gov ID
- NCT05109520
- Acronym / sponsor ID
- FUTURE-GLARE / S65399
- Conditions
- Type 1 Diabetes
- Keywords
- Insulin Glargine 300 U/mL, Continuous glucose monitoring
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 867 participants (actual)
- Lead sponsor
- prof dr Pieter GillardUniversity, hospital or other
- Collaborators
- University Hospital, Antwerp, Onze Lieve Vrouw Hospital
- Study start
- 8 Sep 2021 (actual)
- Primary completion
- 14 Oct 2021 (actual)
- Study completion
- 14 Oct 2021 (actual)
- First posted
- 5 Nov 2021 (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 during the FUTURE study (S59342) to assess the effect of using Insulin Glargine 300 U/mL (Gla-300) on measures of diabetes control and quality of life.
Of the FUTURE participants, data about the type of insulin the participants used will be gathered. On the basis of these data participants will be divided in two groups (control or investigational).
Change in glycemic control and quality of life from before to after the switch to Gla-300 (investigational group) will be compared to the change of glycemic control and quality of life of the FUTURE participants who did not switch to Gla-300 (control group).
The FUTURE study was a 24-month during multicenter observational cohort study analyzing data on the use of the Abbott Freestyle Libre in people with diabetes. Data were gathered during standard clinical follow-up, and from questionnaires that were presented to the participants at defined time points.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| investigational group | – | Drug: Insulin Glargine 300 UNT/ML [Toujeo]Participants of the FUTURE study who switched during the study to Gla-300 |
| control group | – | –Participants of the FUTURE study who did not switch to Insulin Gla-300 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People with type 1 diabetes who participated in the FUTURE study.
Key inclusion criteria (9 listed)
- participant in the FUTURE study for at least 18 months
- diagnosed with type 1 diabetes ≥3 months before start of the FUTURE study
- use of insulin pens for the entirety of the FUTURE study
- use Insulin Detemir (Levemir®), Insulin Glargine 100 U/mL (Lantus®) or an equivalent as basal insulin during the entirety of the FUTURE study
Key exclusion criteria (8 listed)
- Control group
- use of Fast-acting insulin aspart (Fiasp®)
- not using bolus insulin (only basal insulin)
- for women: pregnant or planning pregnancy during the FUTURE study
- switch to Gla-300 (Toujeo®) or Insulin Degludec (Tresiba®) before 18 months in FUTURE study (if switched after 18 months, only data up to switch to Gla-300 [Toujeo®] or Insulin Degludec [Tresiba®] will be used for this control participant)
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 Glargine 300 UNT/ML [Toujeo]Switch during standard routine care to Gla-300. | Drug | investigational group |
Primary outcome
Time in range (TIR, 70-180 mg/dL)
Time frame: maximum 24 months
The difference in evolution of TIR (70-180 mg/dL, averaged per month) over 24 hours since switch to Gla-300
10 secondary outcomes
HbA1c
Time frame: maximum 24 months
Time in range (TIR, 70-180 mg/dL)
Time frame: maximum 24 months
Hypoglycemia
Time frame: maximum 24 months
Hyperglycemia
Time frame: maximum 24 months
Mean glycemia
Time frame: maximum 24 months
Glycemic variability
Time frame: maximum 24 months
Quality of life measured by the Short Form Health Survey 36-item (SF-36) version 2 questionnaire
Time frame: maximum 24 months
Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry
Time frame: maximum 24 months
Distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire
Time frame: maximum 24 months
Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire, status (DTSQs)
Time frame: maximum 24 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 30 Aug 2022.
- Derived from this study: PubMed 38386438Charleer S, Fieuws S, De Block C, Bolsens N, Nobels F, Mikkelsen K, Mathieu C, Gillard P. Evaluation of Glucose Metrics in Adults with Type 1 Diabetes Switching to Insulin Glargine 300 U/mL: A Retrospective, Propensity-Score Matched Study. Diabetes Technol Ther. 2024 Jul;26(7):488-493. doi: 10.1089/dia.2023.0371. Epub 2024 Mar 6.
- Individual participant dataSharing planned: Undecided. IPD can be shared upon a genuine request.
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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.
Pieter Gillard, MD, PhD principal investigator
Universitaire Ziekenhuizen KU Leuven
3 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 3 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 9 inclusion and 8 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 30 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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 (TIR, 70-180 mg/dL) (time frame: maximum 24 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 NCT05109520, 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 30 Aug 2022.