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 (FUTURE-GLARE)
29. august 2022 oppdatert av: prof dr Pieter Gillard
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).
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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Observasjonsmessig
Registrering (Faktiske)
867
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Aalst, Belgia, 9300
- Onze Lieve Vrouw Ziekenhuis Aalst
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Edegem, Belgia, 2650
- Universitair Ziekenhuis Antwerpen
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Leuven, Belgia, 3000
- Universitaire Ziekenhuizen Leuven
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
People with type 1 diabetes who participated in the FUTURE study.
Beskrivelse
Investigational group
Inclusion Criteria:
- 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)
Exclusion Criteria:
- 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
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Case-Control
- Tidsperspektiver: Retrospektiv
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
investigational group
Participants of the FUTURE study who switched during the study to Gla-300
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Switch during standard routine care to Gla-300.
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control group
Participants of the FUTURE study who did not switch to Insulin Gla-300
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Time in range (TIR, 70-180 mg/dL)
Tidsramme: maximum 24 months
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The difference in evolution of TIR (70-180 mg/dL, averaged per month) over 24 hours since switch to Gla-300
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maximum 24 months
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
HbA1c
Tidsramme: maximum 24 months
|
difference in HbA1c
|
maximum 24 months
|
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Time in range (TIR, 70-180 mg/dL)
Tidsramme: maximum 24 months
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difference in TIR (70-180 mg/dL, averaged per month) from 6 am to 10 pm, and from 10 pm to 6 am
|
maximum 24 months
|
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Hypoglycemia
Tidsramme: maximum 24 months
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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
|
maximum 24 months
|
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Hyperglycemia
Tidsramme: maximum 24 months
|
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
|
maximum 24 months
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Mean glycemia
Tidsramme: maximum 24 months
|
difference in mean glucose (averaged per month) over 24 hours, from 6 am to 10 pm, and from 10 pm to 6 am
|
maximum 24 months
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Glycemic variability
Tidsramme: maximum 24 months
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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
|
maximum 24 months
|
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Quality of life measured by the Short Form Health Survey 36-item (SF-36) version 2 questionnaire
Tidsramme: maximum 24 months
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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))
|
maximum 24 months
|
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Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry
Tidsramme: maximum 24 months
|
Fear of hypoglycemia measured by the Hypoglycemia Fear Survey, version II (HFS-II) questionnaire, worry (scale: 0 (not worried) - 72 (very worried))
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maximum 24 months
|
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Distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire
Tidsramme: maximum 24 months
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Distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire (scale: 0 (no distress) - 20 (very distressed))
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maximum 24 months
|
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Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire, status (DTSQs)
Tidsramme: maximum 24 months
|
Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire, status (DTSQs) (scale: 0 (low satisfaction) - 36 (high satisfaction))
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maximum 24 months
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Insulin dose
Tidsramme: maximum 24 months
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difference in insulin dose (basal, bolus and total)
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maximum 24 months
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Body mass index
Tidsramme: maximum 24 months
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difference in body mass index (BMI)
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maximum 24 months
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Severe hypoglycemia rate
Tidsramme: maximum 24 months
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difference in self-reported severe hypoglycemic events
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maximum 24 months
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Hypoglycemic coma rate
Tidsramme: maximum 24 months
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difference in self-reported hypoglycemic comas
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maximum 24 months
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Hospitalization
Tidsramme: maximum 24 months
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difference in hospitalizations due to hypoglycemia or ketoacidosis
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maximum 24 months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Hovedetterforsker: Pieter Gillard, MD, PhD, Universitaire Ziekenhuizen KU Leuven
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
8. september 2021
Primær fullføring (Faktiske)
14. oktober 2021
Studiet fullført (Faktiske)
14. oktober 2021
Datoer for studieregistrering
Først innsendt
14. oktober 2021
Først innsendt som oppfylte QC-kriteriene
3. november 2021
Først lagt ut (Faktiske)
5. november 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
30. august 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
29. august 2022
Sist bekreftet
1. august 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- S65399
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