Diabetes Mellitus, Type 1HYPO-DIADNCT05806190
Hypoglycaemia (Low Blood Sugar) in Adults With Diabetes and Adrenal Failure
An observational study of Diabetes Mellitus, Type 1 and Adrenal Insufficiency, run by Imperial College Healthcare NHS Trust at 1 site in United Kingdom.
Trial summary
The purpose of this study is to measure how often low blood sugars occur in people who live with both adrenal insufficiency (AI) and diabetes and need to take insulin. People who live with AI need to take steroid replacement tablets every day, for life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes Mellitus, Type 1, Adrenal Insufficiency, Diabetes Mellitus Type 2 - Insulin-Treated
- What is being tested?
- Continuous Glucose Monitoring
- Type of treatment
- Medical device
- How many people
- 32 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Apr 2023to 15 Sep 2023
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults living with insulin-treated diabetes and adrenal insufficiency.
Who may be able to join
- for test group:
- Confirmed diagnoses of adrenal insufficiency and insulin-treated diabetes for more than one year.
- Adults aged above 18 years
- for matched control group:
- Diabetes mellitus excluded on baseline blood review
- Adults aged above 18 years
Who cannot join
- Measured eGFR ≤ 30
- Acute illness
- Abnormal thyroid function
- Admission to hospital
- Pregnant or planning pregnancy
- Breastfeeding
Show all 11Show fewer
- Enrolled in other clinical trials, except at the discretion of the chief investigator
- Have active malignancy or under investigation for malignancy
- Severe visual impairment
- Reduced manual dexterity
- Unable to participate due to other factors, as assessed by the Chief Investigators
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Charing Cross Hospital, Imperial College Healthcare NHS Trust
London, w6 8rf
About this study
Official title: Frequency of Nocturnal Hypoglycaemia in Adults With Insulin-treated Diabetes and Adrenal Failure Using Prednisolone or Hydrocortisone: a Pilot Study
The purpose of this study is to measure how often low blood sugars occur in people who live with both adrenal insufficiency (AI) and diabetes and need to take insulin. People who live with AI need to take steroid replacement tablets every day, for life. Two of the most common types of steroid replacement tablets are called prednisolone and hydrocortisone.
Low blood sugar (hypoglycemia) is a very common side effect of taking insulin and can often be unpleasant, frightening and dangerous. People who have adrenal failure are also at risk of hypoglycaemia, although this is rare. It is not known whether taking steroids affects how often hypoglycaemia happens.
Read more
The study has three aims:
- To measure how often low blood sugars occur at night in people who live with with both adrenal insufficiency (AI) and insulin-treated diabetes
- To compare how often low blood sugars occur in people taking prednisolone for their AI versus those taking hydrocortisone.
- To compare the patterns throughout the day for low blood sugars in those taking prednisolone versus those taking hydrocortisone.
The study will compare this information with results in people who have AI without diabetes.
Participants will be given continuous glucose monitoring systems (Dexcom G6 devices) which are small wearable devices that measure glucose levels throughout the day and night. They will be asked to wear a device for 30 days. Participants will not be asked to make any changes to their usual medications or their diet.
Read the detailed description
PURPOSE OF THE STUDY
The purpose of this study is to measure how often hypoglycaemia occurs in people who take steroid tablets for adrenal insufficiency and insulin for diabetes compared to individuals with adrenal insufficiency on steroid tablets without diabetes. To do this, participants will be given a continuous glucose monitoring (CGM) system, which is an effective and accurate way of measuring blood sugars throughout the day and night. This study will assess how often hypoglycaemia occurs, especially at night, and whether the type of steroid tablet people take affects how often hypoglycaemia happens.
STUDY AIMS
- To measure how often low blood sugars occur at night in people with both AI and insulin-treated diabetes using CGM, and in people without diabetes who are matched in age, sex and steroid replacement (hydrocortisone or prednisolone).
- To compare the frequency of low blood sugars in people taking prednisolone for their AI versus those taking hydrocortisone.
- To compare the patterns throughout the day for low blood sugars in those taking prednisolone versus those taking hydrocortisone.
STUDY DESIGN
This study will observe 16 adults with both insulin-treated diabetes and adrenal insufficiency and 16 adults without diabetes who are matched for age, sex and steroid replacement. The investigators will aim to recruit 32 participants in total. Participants will spend 30 days in the study.
RECRUITMENT Recruitment will be undertaken in endocrinology and diabetes clinics at Imperial College Healthcare NHS Trust. Participant information sheets will be given to potential participants and following any questions, informed consent will be taken.
Participants will be given as much time as they require (at least 24 hours) to decide whether or not to take part - this can vary on a per participant basis.
- Conditions
- Diabetes Mellitus, Type 1, Adrenal Insufficiency, Diabetes Mellitus Type 2 - Insulin-Treated
- Being tested
- Continuous Glucose Monitoring
- Medical subject headings
- Diabetes Mellitus, Type 1, Adrenal Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Continuous Glucose MonitoringDevice
Continuous Glucose Monitoring using a Dexcom G6 Continuous Glucose Monitoring Device
| Study group | Role | What they receive |
|---|---|---|
| Study group | Participants who live with insulin- treated diabetes and adrenal insufficiency. Receives: Device: Continuous Glucose Monitoring | |
| Control group | Participants who live with adrenal insufficiency and NOT with insulin-treated diabetes. Receives: Device: Continuous Glucose Monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time spent in hypoglycaemia
Percentage time spent in hypoglycaemia (glucose levels < 3.0mmol/L, 55mg/dL). Glucose levels will be measured by a continuous glucose monitoring device (CGM).
Measured: 30 days
Secondary outcomes (7)
Time spent in hypoglycaemia (glucose levels < 3.9mmol/L, 70mg/dL)
Percentage time spent in hypoglycaemia (glucose levels < 3.9mmol/L, 70mg/dL)
Measured: 30 days
Time spent in target glucose levels
Percentage time spent in target (glucose levels 3.9-10mmol/L, 70-180mg/dL)
Measured: 30 days
Time spent in hyperglycaemia
Percentage time spent in hyperglycaemia (glucose levels >10mmol/L, 180mg/dL)
Measured: 30 days
Hypoglycaemic excursions
Number of hyperglycaemic excursions. This will comprise the number of times glucose sugar levels are recorded as below 3.9mmol/L, 70mg/dL
Measured: 30 days
Gold questionnaire score
The Gold questionnaire asks individuals to report their experience in detecting hypoglycemic events with scores ranging from minimum score of 1 (always aware) to a maximum score of 7 (never aware). The minimum score refers to the individual never being aware of hypoglycaemia, and an increasing score refers to greater awareness of hypoglycaemia.
Measured: Baseline
Hypoglycaemia Fear Survey-II (HFS-II) score
This 33-item questionnaire assesses fear of hypoglycaemia. The minimum score is 0 and the maximum score is 132. A higher score indicated greater fear of hypoglycaemia.
Measured: Baseline
Hospital Anxiety and Depression (HADS) Score
A questionnaire assessing levels of anxiety and depression. The questionnaire consists of 14 questions: 7 questions assess for anxiety and 7 questions assess for depression. Each question can score between 0 and 3. Two scores are calculated separately for anxiety and depression. The minimum score is 0 and maximum score is 21 for both anxiety and depression. A greater score denotes greater severity of anxiety or depression.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2023
- Study start17 Apr 2023
- Primary completion31 Aug 2023
- Study completion15 Sep 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (10)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 1Studies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05806190
- Sponsor's protocol ID
- 22SM8022
- Acronym
- HYPO-DIAD
- Status last verified
- Sep 2023
- First submitted
- 28 Mar 2023
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Bensing S, Brandt L, Tabaroj F, Sjoberg O, Nilsson B, Ekbom A, Blomqvist P, Kampe O. Increased death risk and altered cancer incidence pattern in patients with isolated or combined autoimmune primary adrenocortical insufficiency. Clin Endocrinol (Oxf). 2008 Nov;69(5):697-704. doi: 10.1111/j.1365-2265.2008.03340.x. Epub 2008 Aug 22.
PubMed 18727712Bergthorsdottir R, Leonsson-Zachrisson M, Oden A, Johannsson G. Premature mortality in patients with Addison's disease: a population-based study. J Clin Endocrinol Metab. 2006 Dec;91(12):4849-53. doi: 10.1210/jc.2006-0076. Epub 2006 Sep 12.
PubMed 16968806Chantzichristos D, Persson A, Eliasson B, Miftaraj M, Franzen S, Bergthorsdottir R, Gudbjornsdottir S, Svensson AM, Johannsson G. Mortality in patients with diabetes mellitus and Addison's disease: a nationwide, matched, observational cohort study. Eur J Endocrinol. 2017 Jan;176(1):31-39. doi: 10.1530/EJE-16-0657.
PubMed 27928991Julious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics. 2005;4(4):287-291. doi:https://doi.org/10.1002/pst.185
Lu CL, Shen HN, Hu SC, Wang JD, Li CY. A Population-Based Study of All-Cause Mortality and Cardiovascular Disease in Association With Prior History of Hypoglycemia Among Patients With Type 1 Diabetes. Diabetes Care. 2016 Sep;39(9):1571-8. doi: 10.2337/dc15-2418. Epub 2016 Jul 6.
PubMed 27385329Ngaosuwan K, Johnston DG, Godsland IF, Cox J, Majeed A, Quint JK, Oliver N, Robinson S. Cardiovascular Disease in Patients With Primary and Secondary Adrenal Insufficiency and the Role of Comorbidities. J Clin Endocrinol Metab. 2021 Apr 23;106(5):1284-1293. doi: 10.1210/clinem/dgab063.
PubMed 33585930Ngaosuwan K, Johnston DG, Godsland IF, Cox J, Majeed A, Quint JK, Oliver N, Robinson S. Increased Mortality Risk in Patients With Primary and Secondary Adrenal Insufficiency. J Clin Endocrinol Metab. 2021 Jun 16;106(7):e2759-e2768. doi: 10.1210/clinem/dgab096.
PubMed 33596308Ngaosuwan K, Johnston DG, Godsland IF, Cox J, Majeed A, Quint JK, Oliver N, Robinson S. Mortality Risk in Patients With Adrenal Insufficiency Using Prednisolone or Hydrocortisone: A Retrospective Cohort Study. J Clin Endocrinol Metab. 2021 Jul 13;106(8):2242-2251. doi: 10.1210/clinem/dgab347.
PubMed 33993277Rao Kondapally Seshasai S, Kaptoge S, Thompson A, Di Angelantonio E, Gao P, Sarwar N, Whincup PH, Mukamal KJ, Gillum RF, Holme I, Njolstad I, Fletcher A, Nilsson P, Lewington S, Collins R, Gudnason V, Thompson SG, Sattar N, Selvin E, Hu FB, Danesh J; Emerging Risk Factors Collaboration. Diabetes mellitus, fasting glucose, and risk of cause-specific death. N Engl J Med. 2011 Mar 3;364(9):829-841. doi: 10.1056/NEJMoa1008862.
PubMed 21366474Emerging Risk Factors Collaboration; Sarwar N, Gao P, Seshasai SR, Gobin R, Kaptoge S, Di Angelantonio E, Ingelsson E, Lawlor DA, Selvin E, Stampfer M, Stehouwer CD, Lewington S, Pennells L, Thompson A, Sattar N, White IR, Ray KK, Danesh J. Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative meta-analysis of 102 prospective studies. Lancet. 2010 Jun 26;375(9733):2215-22. doi: 10.1016/S0140-6736(10)60484-9.
PubMed 20609967
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency of Nocturnal Hypoglycaemia in Adults With Insulin-treated Diabetes and Adrenal Failure Using Prednisolone or Hydrocortisone: a Pilot Study
- ClinicalTrials.gov ID
- NCT05806190
- Acronym / sponsor ID
- HYPO-DIAD / 22SM8022
- Conditions
- Diabetes Mellitus, Type 1, Adrenal Insufficiency, Diabetes Mellitus Type 2 - Insulin-Treated
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- 31 Aug 2023 (actual)
- Study completion
- 15 Sep 2023 (actual)
- First posted
- 10 Apr 2023 (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.
The purpose of this study is to measure how often low blood sugars occur in people who live with both adrenal insufficiency (AI) and diabetes and need to take insulin. People who live with AI need to take steroid replacement tablets every day, for life. Two of the most common types of steroid replacement tablets are called prednisolone and hydrocortisone.
Low blood sugar (hypoglycemia) is a very common side effect of taking insulin and can often be unpleasant, frightening and dangerous. People who have adrenal failure are also at risk of hypoglycaemia, although this is rare. It is not known whether taking steroids affects how often hypoglycaemia happens.
The study has three aims:
- To measure how often low blood sugars occur at night in people who live with with both adrenal insufficiency (AI) and insulin-treated diabetes
- To compare how often low blood sugars occur in people taking prednisolone for their AI versus those taking hydrocortisone.
- To compare the patterns throughout the day for low blood sugars in those taking prednisolone versus those taking hydrocortisone.
The study will compare this information with results in people who have AI without diabetes.
Participants will be given continuous glucose monitoring systems (Dexcom G6 devices) which are small wearable devices that measure glucose levels throughout the day and night. They will be asked to wear a device for 30 days. Participants will not be asked to make any changes to their usual medications or their diet.
Detailed description
PURPOSE OF THE STUDY
The purpose of this study is to measure how often hypoglycaemia occurs in people who take steroid tablets for adrenal insufficiency and insulin for diabetes compared to individuals with adrenal insufficiency on steroid tablets without diabetes. To do this, participants will be given a continuous glucose monitoring (CGM) system, which is an effective and accurate way of measuring blood sugars throughout the day and night. This study will assess how often hypoglycaemia occurs, especially at night, and whether the type of steroid tablet people take affects how often hypoglycaemia happens.
STUDY AIMS
- To measure how often low blood sugars occur at night in people with both AI and insulin-treated diabetes using CGM, and in people without diabetes who are matched in age, sex and steroid replacement (hydrocortisone or prednisolone).
- To compare the frequency of low blood sugars in people taking prednisolone for their AI versus those taking hydrocortisone.
- To compare the patterns throughout the day for low blood sugars in those taking prednisolone versus those taking hydrocortisone.
STUDY DESIGN
This study will observe 16 adults with both insulin-treated diabetes and adrenal insufficiency and 16 adults without diabetes who are matched for age, sex and steroid replacement. The investigators will aim to recruit 32 participants in total. Participants will spend 30 days in the study.
RECRUITMENT Recruitment will be undertaken in endocrinology and diabetes clinics at Imperial College Healthcare NHS Trust. Participant information sheets will be given to potential participants and following any questions, informed consent will be taken.
Participants will be given as much time as they require (at least 24 hours) to decide whether or not to take part - this can vary on a per participant basis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study group | – | Device: Continuous Glucose MonitoringParticipants who live with insulin- treated diabetes and adrenal insufficiency. |
| Control group | – | Device: Continuous Glucose MonitoringParticipants who live with adrenal insufficiency and NOT with insulin-treated diabetes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults living with insulin-treated diabetes and adrenal insufficiency.
Key inclusion criteria (6 listed)
- Confirmed diagnoses of adrenal insufficiency and insulin-treated diabetes for more than one year.
- Adults aged above 18 years
- Diabetes mellitus excluded on baseline blood review
- Adults aged above 18 years
Key exclusion criteria (11 listed)
- Measured eGFR ≤ 30
- Acute illness
- Abnormal thyroid function
- Admission to hospital
- Pregnant or planning pregnancy
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 |
|---|---|---|
| Continuous Glucose MonitoringContinuous Glucose Monitoring using a Dexcom G6 Continuous Glucose Monitoring Device | Device | Control group, Study group |
Primary outcome
Time spent in hypoglycaemia
Time frame: 30 days
Percentage time spent in hypoglycaemia (glucose levels < 3.0mmol/L, 55mg/dL). Glucose levels will be measured by a continuous glucose monitoring device (CGM).
7 secondary outcomes
Time spent in hypoglycaemia (glucose levels < 3.9mmol/L, 70mg/dL)
Time frame: 30 days
Time spent in target glucose levels
Time frame: 30 days
Time spent in hyperglycaemia
Time frame: 30 days
Hypoglycaemic excursions
Time frame: 30 days
Gold questionnaire score
Time frame: Baseline
Hypoglycaemia Fear Survey-II (HFS-II) score
Time frame: Baseline
Hospital Anxiety and Depression (HADS) Score
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Background: PubMed 18727712Bensing S, Brandt L, Tabaroj F, Sjoberg O, Nilsson B, Ekbom A, Blomqvist P, Kampe O. Increased death risk and altered cancer incidence pattern in patients with isolated or combined autoimmune primary adrenocortical insufficiency. Clin Endocrinol (Oxf). 2008 Nov;69(5):697-704. doi: 10.1111/j.1365-2265.2008.03340.x. Epub 2008 Aug 22.
- Background: PubMed 16968806Bergthorsdottir R, Leonsson-Zachrisson M, Oden A, Johannsson G. Premature mortality in patients with Addison's disease: a population-based study. J Clin Endocrinol Metab. 2006 Dec;91(12):4849-53. doi: 10.1210/jc.2006-0076. Epub 2006 Sep 12.
- Background: PubMed 27928991Chantzichristos D, Persson A, Eliasson B, Miftaraj M, Franzen S, Bergthorsdottir R, Gudbjornsdottir S, Svensson AM, Johannsson G. Mortality in patients with diabetes mellitus and Addison's disease: a nationwide, matched, observational cohort study. Eur J Endocrinol. 2017 Jan;176(1):31-39. doi: 10.1530/EJE-16-0657.
- BackgroundJulious SA. Sample size of 12 per group rule of thumb for a pilot study. Pharmaceutical Statistics. 2005;4(4):287-291. doi:https://doi.org/10.1002/pst.185
- Background: PubMed 27385329Lu CL, Shen HN, Hu SC, Wang JD, Li CY. A Population-Based Study of All-Cause Mortality and Cardiovascular Disease in Association With Prior History of Hypoglycemia Among Patients With Type 1 Diabetes. Diabetes Care. 2016 Sep;39(9):1571-8. doi: 10.2337/dc15-2418. Epub 2016 Jul 6.
- Background: PubMed 33585930Ngaosuwan K, Johnston DG, Godsland IF, Cox J, Majeed A, Quint JK, Oliver N, Robinson S. Cardiovascular Disease in Patients With Primary and Secondary Adrenal Insufficiency and the Role of Comorbidities. J Clin Endocrinol Metab. 2021 Apr 23;106(5):1284-1293. doi: 10.1210/clinem/dgab063.
- Background: PubMed 33596308Ngaosuwan K, Johnston DG, Godsland IF, Cox J, Majeed A, Quint JK, Oliver N, Robinson S. Increased Mortality Risk in Patients With Primary and Secondary Adrenal Insufficiency. J Clin Endocrinol Metab. 2021 Jun 16;106(7):e2759-e2768. doi: 10.1210/clinem/dgab096.
- Background: PubMed 33993277Ngaosuwan K, Johnston DG, Godsland IF, Cox J, Majeed A, Quint JK, Oliver N, Robinson S. Mortality Risk in Patients With Adrenal Insufficiency Using Prednisolone or Hydrocortisone: A Retrospective Cohort Study. J Clin Endocrinol Metab. 2021 Jul 13;106(8):2242-2251. doi: 10.1210/clinem/dgab347.
- Background: PubMed 21366474Rao Kondapally Seshasai S, Kaptoge S, Thompson A, Di Angelantonio E, Gao P, Sarwar N, Whincup PH, Mukamal KJ, Gillum RF, Holme I, Njolstad I, Fletcher A, Nilsson P, Lewington S, Collins R, Gudnason V, Thompson SG, Sattar N, Selvin E, Hu FB, Danesh J; Emerging Risk Factors Collaboration. Diabetes mellitus, fasting glucose, and risk of cause-specific death. N Engl J Med. 2011 Mar 3;364(9):829-841. doi: 10.1056/NEJMoa1008862.
- Background: PubMed 20609967Emerging Risk Factors Collaboration; Sarwar N, Gao P, Seshasai SR, Gobin R, Kaptoge S, Di Angelantonio E, Ingelsson E, Lawlor DA, Selvin E, Stampfer M, Stehouwer CD, Lewington S, Pennells L, Thompson A, Sattar N, White IR, Ray KK, Danesh J. Diabetes mellitus, fasting blood glucose concentration, and risk of vascular disease: a collaborative meta-analysis of 102 prospective studies. Lancet. 2010 Jun 26;375(9733):2215-22. doi: 10.1016/S0140-6736(10)60484-9.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Mellitus, Type 1 and Adrenal Insufficiency, run by Imperial College Healthcare NHS Trust 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 6 inclusion and 11 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 28 Sep 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?
Time spent in hypoglycaemia (time frame: 30 days). 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 NCT05806190, which also lists 10 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 28 Sep 2023.