Diabetes type1NCT04311021
Current State of Impaired Awareness of Hypoglycaemia in People With Type 1 Diabetes
An observational study of Diabetes type1, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
Rationale: Hypoglycaemia is the most frequent complication of insulin treatment in individuals with type 1 diabetes and a limiting factor for achieving optimal glycaemic control. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Diabetes type1
- How many people
- 700 participants
- Where
- 1 siteNetherlands
- Study dates
- 23 Jan 2020to 1 Feb 2021
- 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 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: Subjects with diabetes type 1.
Who may be able to join
- Type 1 diabetes diagnosis based on clinical judgement with or without auto-antibodies, according to the ISPAD Clinical Practice Consensus Guidelines 2018 (27). Briefly, clinical criteria for the diagnosis of diabetes mellitus include an acute presentation, classical symptoms of diabetes or profound hyperglycaemia with or without ketoacidosis, a plasma glucose concentration ≥11.1 mmol/L and considerably elevated HbA1c, and age of onset >6 months.
- Age ≥16 years.
- Ability to provide written informed consent.
- Fluency in speaking and reading Dutch.
Who cannot join
- Severe psychiatric comorbidity that leads to inability to provide informed consent or as judged by the healthcare provider
- Other comorbidity interfering with completing surveys, as judged by the healthcare professional.
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboudumc
Nijmegen
Namam Ali, Drs, +31243616504, Namam.Ali@radboudumc.nl
Namam Ali
About this study
Official title: Current State of Impaired Awareness of Hypoglycaemia in People With Type 1 Diabetes; Change in Prevalence, Impact of Glucose Monitoring Technology and Psychosocial Impact
Rationale:
Hypoglycaemia is the most frequent complication of insulin treatment in individuals with type 1 diabetes and a limiting factor for achieving optimal glycaemic control. When recurrent, hypoglycaemia can induce a process of habituation, leading to impaired awareness of hypoglycaemia (IAH), a process that can be reversed by meticulous avoidance of hypoglycaemia. In the past 5-10 years, the use of continuous real-time (RT-CGM) or flash glucose monitoring (FGM) has increased rapidly in the clinical management of type 1 diabetes to improve overall glycaemic control and reduce the frequency of hypoglycaemic events, in particular in patients with IAH. It is unknown, however, whether the use of these devices, as well as other improvements in clinical management, has reduced the prevalence IAH and exposure to severe hypoglycaemia (SH) in subjects with type 1 diabetes in a real-world setting. Therefore, it becomes highly appropriate to investigate the current state of IAH and SH in type 1 diabetes. Also, since invites to this study will specifically include people who have taken part of previous assessments, this study will be able to investigate the change in IAH over time and the potential contributing role of RT-CGM/FGM. Furthermore, we want to explore associations of IAH and SH with clinical parameters, quality of life and psychosocial impact. This knowledge will help people with diabetes and their healthcare providers to better adjust treatment recommendations to individual targets.
Read more
Objective:
The primary objective of our study is to investigate the current prevalence of IAH and exposure to severe hypoglycaemia in individuals with diabetes type 1.
The secondary objectives of our study are to:
- Study the difference in IAH prevalence over time in individuals with diabetes type 1.
- Assess the association of RT-CGM/FGM with IAH and SH.
- Study thoughts, emotions and worries which lead to a certain behaviour in case of hypoglycaemia and prevention of hypoglycaemia.
- Study associations of IAH and history of SH with productivity in different situations (work/study, relation/sexuality, driving behaviour/traffic and sport/leisure).
- Study association between partner involvement and handling in case of (unawareness for) hypoglycaemia.
- Study knowledge of subjects with diabetes about hypoglycaemia and IAH.
- Study burden of IAH and severe hypoglycaemia on family members of people with type 1 diabetes, as experienced by patients themselves.
Study design:
This study will be a cross-sectional observational cohort study. The study will be conducted at the Radboud university medical center, department of internal medicine. Subjects with type 1 diabetes will be recruited from outpatient diabetes clinic as well as subjects who participated in two earlier cohorts and agreed to be approached again.
Study population:
The study population will be individuals with diabetes type 1, older than sixteen years old.
Main study parameters/endpoints The main study parameter will be the current prevalence of IAH and exposure to severe hypoglycaemia in the past 12 months.
- Conditions
- Diabetes type1
- Being tested
- No intervention
- Keywords
- Hypoglycemia, Impaired awareness of hypoglycemia, Psychosocial impact, Epidemiology
- Medical subject headings
- Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Diabetes type 1 | Not described Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
The main study parameter will be the current prevalence of IAH and exposure to SH in the past 12 months.
Measured: Past 12 months
Secondary outcomes (3)
Difference in IAH prevalence over the years.
Measured: Past 12 years.
Relationship between IAH/SH prevalence and RT-CGM/FGM vs traditional glucometer use.
Measured: Past 12 months.
Answers to questionnaire
Measured: Past 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start23 Jan 2020
- Primary completion1 Feb 2021 (estimated)
- Study completion1 Feb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetes type1Studies of the same condition, open and under way.
- More trials run by Radboud University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Other
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- HypoResolve
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04311021
- Sponsor's protocol ID
- NL-number: NL71207.091.19
- Status last verified
- Feb 2020
- First submitted
- 28 Feb 2020
- Last updated
- 17 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Current State of Impaired Awareness of Hypoglycaemia in People With Type 1 Diabetes; Change in Prevalence, Impact of Glucose Monitoring Technology and Psychosocial Impact
- ClinicalTrials.gov ID
- NCT04311021
- Acronym / sponsor ID
- NL-number: NL71207.091.19
- Conditions
- Diabetes type1
- Keywords
- Hypoglycemia, Impaired awareness of hypoglycemia, Psychosocial impact, Epidemiology
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Collaborators
- HypoResolve
- Study start
- 23 Jan 2020 (actual)
- Primary completion
- 1 Feb 2021 (estimated)
- Study completion
- 1 Feb 2021 (estimated)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale:
Hypoglycaemia is the most frequent complication of insulin treatment in individuals with type 1 diabetes and a limiting factor for achieving optimal glycaemic control. When recurrent, hypoglycaemia can induce a process of habituation, leading to impaired awareness of hypoglycaemia (IAH), a process that can be reversed by meticulous avoidance of hypoglycaemia. In the past 5-10 years, the use of continuous real-time (RT-CGM) or flash glucose monitoring (FGM) has increased rapidly in the clinical management of type 1 diabetes to improve overall glycaemic control and reduce the frequency of hypoglycaemic events, in particular in patients with IAH. It is unknown, however, whether the use of these devices, as well as other improvements in clinical management, has reduced the prevalence IAH and exposure to severe hypoglycaemia (SH) in subjects with type 1 diabetes in a real-world setting. Therefore, it becomes highly appropriate to investigate the current state of IAH and SH in type 1 diabetes. Also, since invites to this study will specifically include people who have taken part of previous assessments, this study will be able to investigate the change in IAH over time and the potential contributing role of RT-CGM/FGM. Furthermore, we want to explore associations of IAH and SH with clinical parameters, quality of life and psychosocial impact. This knowledge will help people with diabetes and their healthcare providers to better adjust treatment recommendations to individual targets.
Objective:
The primary objective of our study is to investigate the current prevalence of IAH and exposure to severe hypoglycaemia in individuals with diabetes type 1.
The secondary objectives of our study are to:
- Study the difference in IAH prevalence over time in individuals with diabetes type 1.
- Assess the association of RT-CGM/FGM with IAH and SH.
- Study thoughts, emotions and worries which lead to a certain behaviour in case of hypoglycaemia and prevention of hypoglycaemia.
- Study associations of IAH and history of SH with productivity in different situations (work/study, relation/sexuality, driving behaviour/traffic and sport/leisure).
- Study association between partner involvement and handling in case of (unawareness for) hypoglycaemia.
- Study knowledge of subjects with diabetes about hypoglycaemia and IAH.
- Study burden of IAH and severe hypoglycaemia on family members of people with type 1 diabetes, as experienced by patients themselves.
Study design:
This study will be a cross-sectional observational cohort study. The study will be conducted at the Radboud university medical center, department of internal medicine. Subjects with type 1 diabetes will be recruited from outpatient diabetes clinic as well as subjects who participated in two earlier cohorts and agreed to be approached again.
Study population:
The study population will be individuals with diabetes type 1, older than sixteen years old.
Main study parameters/endpoints The main study parameter will be the current prevalence of IAH and exposure to severe hypoglycaemia in the past 12 months.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Diabetes type 1 | – | Other: No intervention |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with diabetes type 1.
Key inclusion criteria (4 listed)
- Type 1 diabetes diagnosis based on clinical judgement with or without auto-antibodies, according to the ISPAD Clinical Practice Consensus Guidelines 2018 (27). Briefly, clinical criteria for the diagnosis of diabetes mellitus include an acute presentation, classical symptoms of diabetes or profound hyperglycaemia with or without ketoacidosis, a plasma glucose concentration ≥11.1 mmol/L and considerably elevated HbA1c, and age of onset >6 months.
- Age ≥16 years.
- Ability to provide written informed consent.
- Fluency in speaking and reading Dutch.
Key exclusion criteria (2 listed)
- Severe psychiatric comorbidity that leads to inability to provide informed consent or as judged by the healthcare provider
- Other comorbidity interfering with completing surveys, as judged by the healthcare professional.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Diabetes type 1 |
Primary outcome
The main study parameter will be the current prevalence of IAH and exposure to SH in the past 12 months.
Time frame: Past 12 months
3 secondary outcomes
Difference in IAH prevalence over the years.
Time frame: Past 12 years.
Relationship between IAH/SH prevalence and RT-CGM/FGM vs traditional glucometer use.
Time frame: Past 12 months.
Answers to questionnaire
Time frame: Past 12 months.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2020.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetes type1, run by Radboud University Medical Center at 1 site in Netherlands.
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 4 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 17 Mar 2020. 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 Netherlands. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The main study parameter will be the current prevalence of IAH and exposure to SH in the past 12 months. (time frame: Past 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Mar 2020; AzTrials last refreshed its copy on 8 Nov 2026.