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Hypoglycaemia (Low Blood Sugar) in Adults With Diabetes and Adrenal Failure (HYPO-DIAD) 32 Dispositif portable Diététique

Terminé
Les détails de l'essai clinique sont principalement disponibles en anglais. Cependant, l'IA Trial Radar peut vous aider ! Cliquez simplement sur 'Expliquer l'étude' pour voir et discuter des informations sur l'étude dans la langue sélectionnée.
L'essai clinique NCT05806190 (HYPO-DIAD) a été une étude observationnel pour Diabète sucré de type 1, Insuffisance surrénalienne, Diabetes Mellitus Type 2 - Insulin-Treated. Son statut actuel est : terminé. L'étude a commencé le 17 avril 2023, avec un objectif de recruter 32 participants. Dirigée par Imperial College Healthcare NHS Trust, l'étude s'est terminée le 15 septembre 2023. Les données du site ClinicalTrials.gov ont été mises à jour pour la dernière fois le 28 septembre 2023.
Résumé succinct
The purpose of this study is to measure how often low blood sugars occur in people who live with both adrenal insufficiency (AI) and diabetes and need to take insulin. People who live with AI need to take steroid replacement tablets every day, for life. Two of the most common types of steroid replacement tablets are called prednisolone and hydrocortisone.

Low blood sugar (hypoglycemia) is a very common side effect o...

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Description détaillée
PURPOSE OF THE STUDY

The purpose of this study is to measure how often hypoglycaemia occurs in people who take steroid tablets for adrenal insufficiency and insulin for diabetes compared to individuals with adrenal insufficiency on steroid tablets without diabetes. To do this, participants will be given a continuous glucose monitoring (CGM) system, which is an effective and accurate way of measuring blood sugars thr...

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Titre officiel

Frequency of Nocturnal Hypoglycaemia in Adults With Insulin-treated Diabetes and Adrenal Failure Using Prednisolone or Hydrocortisone: a Pilot Study

Pathologies
Diabète sucré de type 1Insuffisance surrénalienneDiabetes Mellitus Type 2 - Insulin-Treated
Publications
Articles scientifiques et travaux de recherche publiés sur cet essai clinique:
Autres identifiants de l'étude
  • HYPO-DIAD
  • 22SM8022
Numéro NCT
NCT05806190
Date de début (réel)
2023-04-17
Dernière mise à jour publiée
2023-09-28
Date de fin (estimée)
2023-09-15
Inscription (estimée)
32
Type d'étude
Observationnel
Statut
Terminé
Bras / Interventions
Groupe de participants/BrasIntervention/Traitement
Study group
Participants who live with insulin- treated diabetes and adrenal insufficiency.
Surveillance continue de la glycémie
Continuous Glucose Monitoring using a Dexcom G6 Continuous Glucose Monitoring Device
Control group
Participants who live with adrenal insufficiency and NOT with insulin-treated diabetes.
Surveillance continue de la glycémie
Continuous Glucose Monitoring using a Dexcom G6 Continuous Glucose Monitoring Device
Critère principal d'évaluation
Critères d'évaluationDescription de la mesurePériode
Time spent in hypoglycaemia
Percentage time spent in hypoglycaemia (glucose levels \< 3.0mmol/L, 55mg/dL). Glucose levels will be measured by a continuous glucose monitoring device (CGM).
30 days
Critère secondaire d'évaluation
Critères d'évaluationDescription de la mesurePériode
Time spent in hypoglycaemia (glucose levels < 3.9mmol/L, 70mg/dL)
Percentage time spent in hypoglycaemia (glucose levels \< 3.9mmol/L, 70mg/dL)
30 days
Time spent in target glucose levels
Percentage time spent in target (glucose levels 3.9-10mmol/L, 70-180mg/dL)
30 days
Time spent in hyperglycaemia
Percentage time spent in hyperglycaemia (glucose levels \>10mmol/L, 180mg/dL)
30 days
Hypoglycaemic excursions
Number of hyperglycaemic excursions. This will comprise the number of times glucose sugar levels are recorded as below 3.9mmol/L, 70mg/dL
30 days
Gold questionnaire score
The Gold questionnaire asks individuals to report their experience in detecting hypoglycemic events with scores ranging from minimum score of 1 (always aware) to a maximum score of 7 (never aware). The minimum score refers to the individual never being aware of hypoglycaemia, and an increasing score refers to greater awareness of hypoglycaemia.
Baseline
Hypoglycaemia Fear Survey-II (HFS-II) score
This 33-item questionnaire assesses fear of hypoglycaemia. The minimum score is 0 and the maximum score is 132. A higher score indicated greater fear of hypoglycaemia.
Baseline
Hospital Anxiety and Depression (HADS) Score
A questionnaire assessing levels of anxiety and depression. The questionnaire consists of 14 questions: 7 questions assess for anxiety and 7 questions assess for depression. Each question can score between 0 and 3. Two scores are calculated separately for anxiety and depression. The minimum score is 0 and maximum score is 21 for both anxiety and depression. A greater score denotes greater severity of anxiety or depression.
Baseline
Critères d'éligibilité

Âges éligibles
Adulte, Adulte âgé
Âge minimum
18 Years
Sexes éligibles
Tous

for test group:

  • Confirmed diagnoses of adrenal insufficiency and insulin-treated diabetes for more than one year.
  • Adults aged above 18 years

for matched control group:

  • Diabetes mellitus excluded on baseline blood review
  • Adults aged above 18 years

  • Measured eGFR ≤ 30
  • Acute illness
  • Abnormal thyroid function
  • Admission to hospital
  • Pregnant or planning pregnancy
  • Breastfeeding
  • Enrolled in other clinical trials, except at the discretion of the chief investigator
  • Have active malignancy or under investigation for malignancy
  • Severe visual impairment
  • Reduced manual dexterity
  • Unable to participate due to other factors, as assessed by the Chief Investigators
Imperial College Healthcare NHS Trust logoImperial College Healthcare NHS Trust
Aucune donnée de contact disponible
1 Centres de l'étude dans 1 pays
Charing Cross Hospital, Imperial College Healthcare NHS Trust, London, w6 8rf, United Kingdom