NCT04304963

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
602

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2020

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 9, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 12, 2020

Completed
7 months until next milestone

Study Start

First participant enrolled

October 1, 2020

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2022

Completed
Last Updated

October 11, 2023

Status Verified

July 1, 2023

Enrollment Period

2.1 years

First QC Date

March 9, 2020

Last Update Submit

October 10, 2023

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2HypoglycemiaHypoglycemia Unawareness

Outcome Measures

Primary Outcomes (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).

    week 10

Secondary Outcomes (10)

  • Secondary outcome 1

    week 10

  • Secondary outcome 2

    week 10

  • Secondary outcome 3

    week 10

  • Secondary outcome 4

    week 10

  • Secondary outcome 5

    week 10

  • +5 more secondary outcomes

Study Arms (3)

T1DM and intact awareness of hypoglycaemia

200 participants with T1DM and intact awareness of hypoglycaemia

Other: NO intervention - observational study

T1Dm and impaired awareness of hypoglycaemia

50 participants with T1Dm and impaired awareness of hypoglycaemia

Other: NO intervention - observational study

insulin treated T2DM

350 participants with insulin treated T2DM ( \> 1 injections / day)

Other: NO intervention - observational study

Interventions

NO intervention - observational studyOTHER

NO intervention - observational study

T1DM and intact awareness of hypoglycaemiaT1Dm and impaired awareness of hypoglycaemiainsulin treated T2DM

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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. \[n=350\]

You may qualify if:

  • 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.
  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

King's College London

London, United Kingdom

Location

Related Publications (4)

  • 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.

    PMID: 38512385DERIVED

  • 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.

    PMID: 38386436DERIVED

  • 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.

    PMID: 35633291DERIVED

  • 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.

    PMID: 35105572DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2Hypoglycemia

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 9, 2020

First Posted

March 12, 2020

Study Start

October 1, 2020

Primary Completion

October 31, 2022

Study Completion

October 31, 2022

Last Updated

October 11, 2023

Record last verified: 2023-07

Locations

GB(1)