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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 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

867

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Belgien
      • Aalst, Belgien, 9300
        • Onze Lieve Vrouw Ziekenhuis Aalst
      • Edegem, Belgien, 2650
        • Universitair Ziekenhuis Antwerpen
      • Leuven, Belgien, 3000
        • Universitaire Ziekenhuizen Leuven

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

People with type 1 diabetes who participated in the FUTURE study.

Beskrivelse

  1. 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
  2. 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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Case-Control
  • Tidsperspektiver: Tilbagevirkende kraft

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
investigational group
Participants of the FUTURE study who switched during the study to Gla-300
Medicin: Insulin Glargine 300 UNT/ML [Toujeo]
Switch during standard routine care to Gla-300.
control group
Participants of the FUTURE study who did not switch to Insulin Gla-300

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Time in range (TIR, 70-180 mg/dL)
Tidsramme: maximum 24 months
The difference in evolution of TIR (70-180 mg/dL, averaged per month) over 24 hours since switch to Gla-300
maximum 24 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
HbA1c
Tidsramme: maximum 24 months
difference in HbA1c
maximum 24 months
Time in range (TIR, 70-180 mg/dL)
Tidsramme: maximum 24 months
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
Hypoglycemia
Tidsramme: maximum 24 months
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
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
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
Glycemic variability
Tidsramme: maximum 24 months
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
Quality of life measured by the Short Form Health Survey 36-item (SF-36) version 2 questionnaire
Tidsramme: maximum 24 months
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
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))
maximum 24 months
Distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire
Tidsramme: maximum 24 months
Distress due to diabetes measured by the Problem Areas In Diabetes survey, short form (PAID-SF) questionnaire (scale: 0 (no distress) - 20 (very distressed))
maximum 24 months
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))
maximum 24 months

Andre resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Insulin dose
Tidsramme: maximum 24 months
difference in insulin dose (basal, bolus and total)
maximum 24 months
Body mass index
Tidsramme: maximum 24 months
difference in body mass index (BMI)
maximum 24 months
Severe hypoglycemia rate
Tidsramme: maximum 24 months
difference in self-reported severe hypoglycemic events
maximum 24 months
Hypoglycemic coma rate
Tidsramme: maximum 24 months
difference in self-reported hypoglycemic comas
maximum 24 months
Hospitalization
Tidsramme: maximum 24 months
difference in hospitalizations due to hypoglycemia or ketoacidosis
maximum 24 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

prof dr Pieter Gillard

Samarbejdspartnere

University Hospital, Antwerp
Onze Lieve Vrouw Hospital

Efterforskere

  • Ledende efterforsker: Pieter Gillard, MD, PhD, Universitaire Ziekenhuizen KU Leuven

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

8. september 2021

Primær færdiggørelse (Faktiske)

14. oktober 2021

Studieafslutning (Faktiske)

14. oktober 2021

Datoer for studieregistrering

Først indsendt

14. oktober 2021

Først indsendt, der opfyldte QC-kriterier

3. november 2021

Først opslået (Faktiske)

5. november 2021

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

30. august 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

29. august 2022

Sidst verificeret

1. august 2022

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • S65399

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Kliniske forsøg med Type 1 diabetes

Kliniske forsøg med Insulin Glargine 300 UNT/ML [Toujeo]

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