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.

Recruiting

Conditions: Diabetes mellitus
''sugar disease''
10018424

Registration Number: NL-OMON49518

Lead Sponsor: Radboud Universitair Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: Not specified

Target Recruitment: 75

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

1. Concurrent conditions that can affect glucose readings [renal impairment GFR
< 30 ml/min, hepatic impairment, untreated adrenal or thyroid insufficiency, as
judged by the investigator.
2. Severe cognitive impairment or psychological illness that can impair
performance of EMA tasks, visual impairment that will preclude use of the EMA
or sensors.
3. Severe psychiatric / psychological illness including extreme fear of hypo-
or hyper- glycaemia ( in the opinion of the investigator)
4. Pregnant or plans for pregnancy in the next 6 months
5. Use of automated insulin delivery systems such as closed loop or automated
threshold suspend or predictive low glucose suspend insulin pumps.
6. Known allergies to adhesives required for the CGM systems
7. People who work regular night shifts
8. Any other condition which in the opinion of the study team would impair
their ability to complete the study

Study & Design

Study Type: Observational invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Determine the Low Interstitial Glucose (LIG) parameters that have the optimum<br /><br>performance for detection and identification of patient-reported-hypoglycemia<br /><br>(PRH); LIG_PRH (h_opt,t_opt).</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Impact of symptomatic and asymptomatic hypoglycaemia on different domains of<br /><br>Quality of Life (QoL) and health economic variables. </p><br>