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Diabetes Self-management With Continuous Glucose Monitoring (DIASELF) 500 Observationeel

Nog niet rekruterend
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De klinische studie NCT06453434 (DIASELF) is een observationeel studie bij Type 1 diabetes met de status nog niet rekruterend. De inclusie van 500 deelnemers start op 1 juli 2024. De studie wordt geleid door Nordsjaellands Hospital en de voltooiing is gepland op 1 augustus 2026. Laatste update op ClinicalTrials.gov: 11 juni 2024.
Beknopte samenvatting

The overall goal of this observational study is to investigate the interaction between people with type 1 diabetes and continuous glucose monitoring (CGM) and the impact of this interaction on quality of life, particularly the level of diabetes distress, and glycaemic metrics.

Participants will:

  • Visit the clinic twice with a 14-day interval
  • Fill out a survey before the first and at the last visit
  • Use CGM as u...
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Uitgebreide beschrijving
A two-centre observational study conducted in Denmark, including adults with type 1 diabetes (n=500) on multiple daily injections already using FreeStyle Libre 2.

Upon recruitment, participants will complete a survey of 11 validated questionnaires, including T1-DDS-28. For 14 days, participants will continue regular CGM use, smart insulin pens will record real-time insulin dosage, and an activity sensor will monitor...

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Officiële titel

The Impact of Continuous Glucose Monitoring Based Self-management on Patient-Reported Outcomes and Glycaemia in Type 1 Diabetes

Aandoeningen
Type 1 diabetes
Publicaties
Wetenschappelijke artikelen en onderzoekspapers gepubliceerd over deze klinische studie:
Andere studie-ID's
  • DIASELF
  • U1111-1306-6133
NCT-ID
NCT06453434
Startdatum (Werkelijk)
2024-07-01
Laatste update geplaatst
2024-06-11
Verwachte einddatum
2026-08
Inschrijving (Geschat)
500
Studietype
Observationeel
Status
Nog niet rekruterend
Trefwoorden
Continuous Glucose Monitoring
Self-management
Diabetes Technology
Type 1 Diabetes
Diabetes Distress
Patient-reported Outcomes
Primaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Diabetes Distress
Type 1 Diabetes Distress Scale (T1-DDS-28)) Score. Likert scale. Score from 1 to 5. Higher scores indicate higher grade of diabetes distress.
At baseline and after 14 days.
Secundaire uitkomst
UitkomstmaatBeschrijving van de uitkomstmaatTijdsbestek
Time in range (TIR)
Time in range defined as the percentage of time the sensor glucose is 3.9-10.0 mmol/L (70-180 mg/dL)
14 days
Time in tight range (TIR)
The percentage of time the sensor glucose is 3.9-7.8 mmol/L (70-140 mg/dL)
14 days
Time below range level 1 (TBR1)
The percentage of time the sensor glucose is 3.0-3.9 mmol/L (54-70 mg/dL)
14 days
Time below range level 2 (TBR2)
The percentage of time the sensor glucose is \<3.0 mmol/L (\<54 mg/dL)
14 days
TBR1 night
TBR 3.0-3.9 from 0000h to 0559h, level 1 night
14 days
TBR1 day
TBR 3.0-3.9 from 0600h to 2359h, level 1 day
14 days
TBR2 night
TBR \<3.0 from 0000h to 0559h, level 2 night
14 days
TBR2 day
TBR \<3.0 from 0600h to 2359h, level 2 day
14 days
Time above range level 1 (TAR1)
The percentage of time the sensor glucose is 10.1-13.9 mmol/L (181-250 mg/dL)
14 days
Time above range level 2 (TAR2)
The percentage of time the sensor glucose is 13.9 mmol/L (\>250 mg/dL)
14 days
TAR1 night
TAR1 10.1-13.9 from 0000h to 0559h, level 1 night
14 days
TAR1 day
TAR1 10.1-13.9 from 0600h to 2359h, level 1 day
14 days
TAR2 night
TAR2 \>13.9 from 0000h to 0559h, level 1 night
14 days
TAR2 day
TAR2 \>13.9 from 0600h to 2359h, level 1 day
14 days
Coefficient of variation (CV)
Measure of glucose variability. Calculated as 100 x (SD divided by mean glucose)
14 days
Mean sensor glucose
Mean sensor glucose (mmol/L and mg/dL)
14 days
Standard deviation of mean glucose (SD)
Standard deviation of mean glucose (SD) (mmol/L and mg/dL)
14 days
Deelname-assistent
Geschiktheidscriteria

Leeftijd van deelnemers
Volwassene, Oudere volwassene
Minimumleeftijd
18 Years
Geslachten die in aanmerking komen voor de studie
Allen
  1. Age between 18 and 85 years.
  2. Diagnosed with T1D over one year ago.
  3. Actively using FreeStyle Libre 2 (>80% sensor activity).
  4. Used FreeStyle Libre 2 for over three months.
  5. Uses multiple daily insulin injections.
  6. Capable of providing written informed consent.
  7. Willing and able to complete study procedures, including using smart caps or pens and completing questionnaires at the investigator's discretion.

  1. History of allergic reactions to materials or adhesives used in CGM devices.
  2. Presence of severe cognitive or psychiatric conditions that could hinder the effective use of CGM or smart caps or pens - at the investigator's discretion.
  3. Current use of steroids unless part of a chronic therapy plan.
  4. Daily consumption of vitamin C ≥ 500 mg.
Nordsjaellands Hospital logoNordsjaellands Hospital
Steno Diabetes Center Copenhagen logoSteno Diabetes Center Copenhagen
Centraal Contactpersoon
Contact: Mette J Nitschke, PhD Student, +45 41 24 72 16, [email protected]
Contact: Ulrik Pedersen-Bjergaard, Professor, [email protected]
2 Studielocaties in 1 landen

Capital Region

Steno Diabetes Center Copenhagen, Herlev, Capital Region, 2730, Denmark
Kirsten Nørgaard, Professor, Contact, +45 27 13 10 11, [email protected]
Kirsten Nørgaard, Professor, Hoofdonderzoeker
Copenhagen University Hospital, North Zealand - Hilleroed, Hillerød, Capital Region, 3400, Denmark
Mette J Nitschke, PhD student, Contact, +45 41 24 72 16, [email protected]
Mette J Nitschke, PhD student, Subonderzoeker
Ulrik Pedersen-Bjergaard, Professor, Hoofdonderzoeker