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Diabetes Mellitus, Type 1Hypo-METRICSNCT04304963

Hypo-METRICS: Hypoglycaemia - Measurement, ThResholds and ImpaCtS

An observational study of Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by King's College London at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Hypoglycaemia or low blood glucose, and its fear are major barriers to achieving optimal glucose control. New technology, such as continuous glucose monitors (CGM), help to better identify hypoglycaemia and develop strategies to avoid it. Read more about this study

Who is it for?
Ages 18 to 85 years
Type of treatment
Injection or infusion
How many people
602 participants
Where
1 siteUnited Kingdom
Study dates
1 Oct 2020to 31 Oct 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 85 years
  • All sexes
  • Adult, Older adult

Study population: A total of 600 participants will be recruited in the following categories. * Type 1 diabetes with intact awareness of hypoglycaemia [ Gold score < 3]; a maximum of 50% will be using flash or continuous glucose monitoring [ n = 200 ] * Type 1 diabetes with impaired awareness of hypoglycaemia [ gold score > 4 ];[n=50] a maximum of 50% will be using flash or continuous glucose monitoring * Type 2 diabetes on > 1 injections; a minimum of 25% of these participants will be over 60 years of age; a maximum of 50% will be using flash or continuous glucose monitoring. [n=350]

Who may be able to join

  • Age 18 - 85 years
  • HbA1c 5 - 10% [31 - 86 mmol/mol]
  • Confirmed diagnosis of type 1 or type 2 diabetes
  • Using > 1 injection of insulin / day or insulin pump.
  • Ability to provide written informed consent
  • 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.
Show all 9Show fewer
  • At least 1 episode of hypoglycaemia [ either biochemical or symptomatic] in the last month
  • On stable therapy for at least 3 months.
  • 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)

Who cannot join

  • 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.
  • Severe cognitive impairment or psychological illness that can impair performance of EMA tasks, visual impairment that will preclude use of the EMA or sensors.
  • Severe psychiatric / psychological illness including extreme fear of hypo- or hyper- glycaemia ( in the opinion of the investigator)
  • Pregnant or plans for pregnancy in the next 6 months
  • Use of automated insulin delivery systems such as closed loop or automated threshold suspend or predictive low glucose suspend insulin pumps.
  • Known allergies to adhesives required for the CGM systems
  • People who work regular night shifts
  • Any other condition which in the opinion of the study team would impair their ability to complete the study

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

  • King's College London

    London

Other trials in United Kingdom

About this study

Official title: 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.

Hypoglycaemia or low blood glucose, and its fear are major barriers to achieving optimal glucose control. New technology, such as continuous glucose monitors (CGM), help to better identify hypoglycaemia and develop strategies to avoid it. These devices measure glucose in the skin, rather than in the blood, and provide information not only on how low glucose is, but also for how long. Recent studies showed that over half of episodes of low glucose with these systems are not recognised by people with diabetes, and even people without diabetes have sensor values that are below the current thresholds for hypoglycaemia [ low blood glucose] that we measure with traditional monitors.

In this study, the investigators will evaluate the impact of symptomatic as well as asymptomatic episodes of low sensor glucose on a variety of clinical, patient-related and health economic outcomes such as mood, quality of sleep and productivity. The investigators will test different levels and durations of low sensor glucose to identify the one that best matches episodes that are symptomatic to best define hypoglycaemia using these systems.

The investigators will also look at factors that influence this such as sleep or activity as well as diabetes management behaviours (such as insulin dosing, carb counting, etc). At the end of this study, the investigators will be able to provide a better definition of clinically relevant low sensor glucose readings that will help inform clinical as well as academic interpretation of CGM data.

Being tested
NO intervention - observational study
Medical subject headings
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2, Hypoglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NO intervention - observational studyOther

    NO intervention - observational study

Study groups in NCT04304963
Study groupRoleWhat they receive
T1DM and intact awareness of hypoglycaemia200 participants with T1DM and intact awareness of hypoglycaemia
Receives: Other: NO intervention - observational study
T1Dm and impaired awareness of hypoglycaemia50 participants with T1Dm and impaired awareness of hypoglycaemia
Receives: Other: NO intervention - observational study
insulin treated T2DM350 participants with insulin treated T2DM ( > 1 injections / day)
Receives: Other: NO intervention - observational study

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. LIG optimum detection of hypoglycemia

    To 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).

    Measured: week 10

Secondary outcomes (10)

  1. Secondary outcome 1

    To evaluate the impact of symptomatic and asymptomatic hypoglycaemia on different domains of Quality of Life (QoL) and health economic variables measured by a bespoke mobile phone application.

    We will use the definition of LIG identified in the primary objective, 〖LIG〗_PRH (h_opt,t_opt), to evaluate the impact of symptomatic and asymptomatic hypoglycaemia on various outcome variables. To do this, we will divide the days into one of 4 categories LIG-PRH- :no hypoglycaemia LIG+PRH- :asymptomatic biochemical hypoglycaemia ( CGM false positive) LIG+PRH+ :symptomatic biochemical hypoglycaemia LIG-PRH+ :symptomatic without biochemical hypoglycaemia (CGM false negative) We will then compare the scores in different domains collected on the app ( eg reported mood, quality of sleep, alertness, productivity, time off work) between the 4 categories.

    Measured: week 10

  2. Secondary outcome 2

    To evaluate the impact of adding co-variates such as change of glucose for 30 minutes prior to the event and area under the curve to the threshold and duration parameters to see if this can improve the sensitivity and specificity of 〖LIG〗_PRH (h_opt,t_opt),

    Measured: week 10

  3. Secondary outcome 3

    To evaluate the impact on these optimal parameters [〖LIG〗_PRH (h_opt,t_opt ] on Type of diabetes ( Type 1 with normal awareness, Type 2, Type 1 with impaired awareness) Awake vs sleeping ( as determined by Fitbit) Usual Mode of glucose monitoring (SMBG vs Flash vs CGM) Rate of 〖LIG〗_PRH during the study

    Measured: week 10

  4. Secondary outcome 4

    To evaluate the impact of the rate of 〖LIG〗_PRH over the whole study duration on Rate of Patient reported hypoglycaemia ( non-severe) Rate of severe hypoglycaemia Overall EQ-5D-5L scores WPAI ( productivity) PROMIS - (sleep quality) Hypo fear scores Baseline C-peptide levels

    Measured: week 10

  5. Secondary outcome 5

    To determine the parameters (threshold and duration) of low interstitial glucose (LIG) that best identify a pre-specified reduction/ change in QoL. [ 0.07 reduction in EQ-5D-5L] 〖LIG〗_(EQ-5D) (h_opt,t_opt).

    Measured: week 10

  6. Secondary outcome 6

    To determine the parameters ( threshold and duration) of low interstitial glucose (LIG) that best identify a pre-specified health economic outcome. [1.5 hour loss of effective work/ activity] 〖LIG〗_productivity (h_opt,t_opt).

    Measured: week 10

  7. Secondary outcome 7

    Determining the predictors of 〖LIG〗_PRH by looking at variables such as mean glucose, variability, activity (step count and intensity).

    Measured: week 10

  8. Secondary outcome 8

    We will evaluate the impact of activity ( step count) on the risk of 〖LIG〗_PRH the following night. A generalized linear mixed models (GLMM) with step count as the independent variable and the rate of LIG_PRH as the response variable will address this research question

    Measured: week 10

  9. Secondary outcome 9

    We will try to understand some of the causes of hypoglycaemia. To do this we will look at the 4 hours prior to every available 〖LIG〗_PRH (h_opt,t_opt) and PRH and describe the category of events (if also insulin data is available) by classifying them into those with Bolus within range [ < 10 mmol/l] within 4 hours Bolus and correction [ > 10 mmol/l ] within 4 hours No bolus within 4 hours Activity [ as identified by the Fitbit charge 3] within 2 hours.

    Measured: week 10

  10. Secondary outcome 10

    Evaluating the effect of personality (assessed by DS-14) on number and severity of hypoglycaemia and the effect of hypoglycaemia on quality of life measures

    Measured: week 10

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Mar 2020
  2. Study start1 Oct 2020
  3. Primary completion31 Oct 2022
  4. Study completion31 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
602 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04304963
Sponsor's protocol ID
259415
Acronym
Hypo-METRICS
Status last verified
Jul 2023
First submitted
9 Mar 2020
Last updated
11 Oct 2023
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Ajie M, Ali N, Hendriksz MS, Divilly P, Rietveld MJ, Abbink EJ, Choudhary P, Brosen JMB, Pedersen-Bjergaard U, McCrimmon RJ, Evans M, Mader JK, de Galan BE, Stienstra R, Tack CJ; Hypo-RESOLVE Consortium. Sensor-Detected Hypoglycaemia Is Associated With Inflammatory Protein and Immune Cell Alterations in People With Diabetes: Findings From the Hypo-METRICS Study. Diabetes Obes Metab. 2026 Sep 17. doi: 10.1111/dom.71321. Online ahead of print.

    PubMed 42755124

  • Brosen JMB, Malmsio D, Divilly P, Martine-Edith G, Zaremba N, Ali N, McCrimmon RJ, Heller S, Evans M, de Galan B, Mader JK, Renard E, Vaag AA, Choudhary P, Pedersen-Bjergaard U; HypoRESOLVE Consortium. Person-Reported and Continuous Glucose Monitoring (CGM) Recorded Hypoglycaemia in People With Insulin-Treated Type 2 Diabetes and Mild to Moderate Chronic Kidney Disease; Post Hoc Analysis From the Hypo-METRICS Study. Diabetes Obes Metab. 2026 Sep 1. doi: 10.1111/dom.71247. Online ahead of print.

    PubMed 42677701

  • Martine-Edith G, Zaremba N, Divilly P, Soholm U, Broadley M, Baumann PM, Mahmoudi Z, Gomes M, Ali N, Abbink EJ, de Galan B, Brosen J, Pedersen-Bjergaard U, Vaag AA, McCrimmon RJ, Renard E, Heller S, Evans M, Cigler M, Mader JK, Amiel SA, Speight J, Pouwer F, Choudhary P. Associations Between Hypoglycemia Awareness Status and Symptoms of Hypoglycemia Among Adults with Type 1 or Insulin-Treated Type 2 Diabetes Using the Hypo-METRICS Smartphone Application. Diabetes Technol Ther. 2024 Aug;26(8):566-574. doi: 10.1089/dia.2023.0596. Epub 2024 Apr 12.

    PubMed 38512385

  • Martine-Edith G, Divilly P, Zaremba N, Soholm U, Broadley M, Baumann PM, Mahmoudi Z, Gomes M, Ali N, Abbink EJ, de Galan B, Brosen J, Pedersen-Bjergaard U, Vaag AA, McCrimmon RJ, Renard E, Heller S, Evans M, Cigler M, Mader JK, Speight J, Pouwer F, Amiel SA, Choudhary P, Hypo-Resolve FT. A Comparison of the Rates of Clock-Based Nocturnal Hypoglycemia and Hypoglycemia While Asleep Among People Living with Diabetes: Findings from the Hypo-METRICS Study. Diabetes Technol Ther. 2024 Jul;26(7):433-441. doi: 10.1089/dia.2023.0522. Epub 2024 Apr 17.

    PubMed 38386436

  • Divilly P, Zaremba N, Mahmoudi Z, Soholm U, Pollard DJ, Broadley M, Abbink EJ, de Galan B, Pedersen-Bjergaard U, Renard E, Evans M, Speight J, Brennan A, McCrimmon RJ, Mullenborn M, Heller S, Seibold A, Mader JK, Amiel SA, Pouwer F, Choudhary P; Hypo-RESOLVE Consortium. Hypo-METRICS: Hypoglycaemia-MEasurement, ThResholds and ImpaCtS-A multi-country clinical study to define the optimal threshold and duration of sensor-detected hypoglycaemia that impact the experience of hypoglycaemia, quality of life and health economic outcomes: The study protocol. Diabet Med. 2022 Sep;39(9):e14892. doi: 10.1111/dme.14892. Epub 2022 Jun 22.

    PubMed 35633291

  • Soholm U, Broadley M, Zaremba N, Divilly P, Nefs G, Mahmoudi Z, de Galan B, Pedersen-Bjergaard U, Brennan A, Pollard DJ, McCrimmon RJ, A Amiel S, Hendrieckx C, Speight J, Choudhary P, Pouwer F; Hypo-RESOLVE Consortium. Investigating the day-to-day impact of hypoglycaemia in adults with type 1 or type 2 diabetes: design and validation protocol of the Hypo-METRICS application. BMJ Open. 2022 Feb 1;12(2):e051651. doi: 10.1136/bmjopen-2021-051651.

    PubMed 35105572

Questions about this trial

What is this clinical trial studying?

An observational study of Diabetes Mellitus, Type 1 and Diabetes Mellitus, Type 2, run by King's College London at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

LIG optimum detection of hypoglycemia (time frame: week 10). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04304963, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2023.

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