Hypo-METRICS: Hypoglycaemia - Measurement, ThResholds and ImpaCtS;A clinical study to Determine the Optimal Threshold and duration of low interstitial glucose events that have an impact on patient experienced hypoglycaemia, quality of life and health economic outcomes.

Hypo-METRICS: Hypoglycaemia - Measurement, ThResholds and ImpaCtS;A clinical study to Determine the Optimal Threshold and duration of low interstitial glucose events that have an impact on patient experienced hypoglycaemia, quality of life and health economic outcomes. - Hypo-METRICS

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON49518

Enrollment

Registered

2020-07-06

Start date

2021-01-29

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

Diabetes mellitus ''sugar disease''

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: 1. Age 18 - 85 years 2. HbA1c 5 * 10% [31 * 86 mmol/mol] 3. Confirmed diagnosis of type 1 or type 2 diabetes 4. Using > 1 injection of insulin / day or insulin pump. 5. Ability to provide written informed consent 6. Performing regular SMBG [ > 1 / day on a 4-week download] . For those using flash or continuous glucose monitoring, this should be used at least 70% of the time. 7. At least 1 episode of hypoglycaemia [ either biochemical or symptomatic] in the last month 8. On stable therapy for at least 3 months. 9. Willing to complete study procedures including wearing the Fitbit and CGM devices and completing the EMA questionnaires on the uMotif app three times a day for 10 weeks ( we expect minimum 80% data completeness)

Exclusion criteria

Exclusion criteria: 1. Concurrent conditions that can affect glucose readings [renal impairment GFR

Design outcomes

Primary

Measure	Time frame
Determine the Low Interstitial Glucose (LIG) parameters that have the optimum performance for detection and identification of patient-reported-hypoglycemia (PRH); LIG_PRH (h_opt,t_opt).	—

Secondary

Measure	Time frame
Impact of symptomatic and asymptomatic hypoglycaemia on different domains of Quality of Life (QoL) and health economic variables.	—

Countries

Netherlands

Outcome results