ECSPECT-HYPO trial

Effectiveness of Continuous Glucose Monitoring versus Stepped Care with HypoAware, a Web-Based PsychoEducational Intervention, and adding CGM as needed, in Adult Type 1 Diabetes with Impaired Hypoglycemia Awareness: ECSPECT-HYPO trial.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29063

Enrollment

115

Registered

2017-12-19

Start date

2018-04-01

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes type 1, Hypoglycaemia, Impaired awareness of hypoglycemia, Continuous glucose monitoring, Psychoeducation. Diabetes type 1, Hypoglycaemie, Hypoproblematiek, Continue glucose monitoring, Psychoeducatie.

Interventions

- Continuous glucose monitoring (CGM) - Stepped Care: starting with HypoAware (step 1), a psycho-educational programme, and later adding CGM if needed (step 2)

Eligibility

Inclusion criteria

Inclusion criteria: - 18 years or older - Type 1 diabetes, treated with either continuous subcutaneous insulin infusion (CSII) or multiple daily insulin injections (MDI) - Impaired awareness of hypoglycemia, as defined by Gold criteria (i.e., with a Gold score >=4) and one or more severe hypoglycemic events (defined as events requiring external assistance) the past two years

Exclusion criteria

Exclusion criteria: - Renal insufficiency, with glomerular filtration rate (GFR) 21 units/week, women >14 units/week) - Pregnancy or pregnancy wish - Current use of FreeStyle Libre, acquired < 3 months prior to screening for problems with hypoglycemia¡¯s - Any hearing or vision impairment that could hinder perception of the glucose display and alarms, or otherwise incapable of using a (RT-)CGM, in the opinion of the investigator - Poor command of the Dutch language or any (mental) disorder that precluded full understanding of the purpose and instructions of the study - Any known or suspected allergy to trial-related products

Design outcomes

Primary

Measure	Time frame
Frequency of (self-reported) severe hypoglycemia	—

Secondary

Measure	Time frame
Hypoglycemia awareness (Gold score); frequency of mild hypoglycemia; glycosylated hemoglobin (HbA1c); results from the diagnostic glucose sensor: time spent in the euglycemic range (interstitial glucose >3.9-<10.0 mmol/L), sensor-derived hypoglycaemic events, nocturnal hypoglycemia, area under curve (AUC) ¡Ü3.9 mmol/L and glucose variability; psychological well-being: fear of hypoglycemia (Hypoglycemia Fear Survey (HFS-II)), diabetes-related distress (PAID); quality adjusted life years (QALYs) and societal costs consisting of costs of healthcare consumption, informal care and lost productivity.	—

Measure

Time frame

Hypoglycemia awareness (Gold score); frequency of mild hypoglycemia; glycosylated hemoglobin (HbA1c); results from the diagnostic glucose sensor: time spent in the euglycemic range (interstitial glucose >3.9-<10.0 mmol/L), sensor-derived hypoglycaemic events, nocturnal hypoglycemia, area under curve (AUC) ¡Ü3.9 mmol/L and glucose variability; psychological well-being: fear of hypoglycemia (Hypoglycemia Fear Survey (HFS-II)), diabetes-related distress (PAID); quality adjusted life years (QALYs) and societal costs consisting of costs of healthcare consumption, informal care and lost productivity.

—

Contacts

Public ContactC. Racca

c.racca@vumc.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)