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 augusti 2022 uppdaterad 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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Observationell
Inskrivning (Faktisk)
867
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
-
-
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Aalst, Belgien, 9300
- Onze Lieve Vrouw Ziekenhuis Aalst
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Edegem, Belgien, 2650
- Universitair Ziekenhuis Antwerpen
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Leuven, Belgien, 3000
- Universitaire Ziekenhuizen Leuven
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Testmetod
Icke-sannolikhetsprov
Studera befolkning
People with type 1 diabetes who participated in the FUTURE study.
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Observationsmodeller: Case-Control
- Tidsperspektiv: Retrospektiv
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
investigational group
Participants of the FUTURE study who switched during the study to Gla-300
|
Switch during standard routine care to Gla-300.
|
|
control group
Participants of the FUTURE study who did not switch to Insulin Gla-300
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Time in range (TIR, 70-180 mg/dL)
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
HbA1c
Tidsram: maximum 24 months
|
difference in HbA1c
|
maximum 24 months
|
|
Time in range (TIR, 70-180 mg/dL)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: maximum 24 months
|
Treatment satisfaction measured by the Diabetes Treatment Satisfaction Questionnaire, status (DTSQs) (scale: 0 (low satisfaction) - 36 (high satisfaction))
|
maximum 24 months
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Insulin dose
Tidsram: maximum 24 months
|
difference in insulin dose (basal, bolus and total)
|
maximum 24 months
|
|
Body mass index
Tidsram: maximum 24 months
|
difference in body mass index (BMI)
|
maximum 24 months
|
|
Severe hypoglycemia rate
Tidsram: maximum 24 months
|
difference in self-reported severe hypoglycemic events
|
maximum 24 months
|
|
Hypoglycemic coma rate
Tidsram: maximum 24 months
|
difference in self-reported hypoglycemic comas
|
maximum 24 months
|
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Hospitalization
Tidsram: maximum 24 months
|
difference in hospitalizations due to hypoglycemia or ketoacidosis
|
maximum 24 months
|
Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Pieter Gillard, MD, PhD, Universitaire Ziekenhuizen KU Leuven
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
8 september 2021
Primärt slutförande (Faktisk)
14 oktober 2021
Avslutad studie (Faktisk)
14 oktober 2021
Studieregistreringsdatum
Först inskickad
14 oktober 2021
Först inskickad som uppfyllde QC-kriterierna
3 november 2021
Första postat (Faktisk)
5 november 2021
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
30 augusti 2022
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
29 augusti 2022
Senast verifierad
1 augusti 2022
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- S65399
Plan för individuella deltagardata (IPD)
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Obeslutsam
IPD-planbeskrivning
IPD can be shared upon a genuine request.
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