Diabetic KetoacidosisRESGUE1NCT04819178
Real Life Evaluation of SGLT2 Use in Type 1 Diabetes
An observational study of Diabetic Ketoacidosis, run by Steno Diabetes Center Copenhagen at 3 sites in Denmark.
Trial summary
The primary aim of the study is to prospectively monitor the risk of diabetic ketoacidosis (DKA) during treatment with sodium-glucose cotransporter 2 (SGLT2) inhibitors in type 1 diabetes after the treatment has become available as an adjunct therapy for people with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetic Ketoacidosis
- How many people
- 0 participants
- Where
- 3 sitesDenmark
- Study dates
- 1 Jun 2021to 1 Dec 2021
- How long will I take part?
- 3 Years
- 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 90 years
- All sexes
- Adult, Older adult
Study population: Individuals with type 1 diabetes initiated on SGLT2 inhibition will be prospectively included after provision of informed consent. We have established a national network of centers and investigators involved in the treatment of type 1 diabetes. We aim to offer inclusion in the study to every individual where SGLT2 inhibitor treatment is planned
Who may be able to join
- All patiens with type 1 diabetes on SGLT2 inhibitor treatment or where this treatment is planned.
Who cannot join
- None
Trial locations and contacts
3 sites in 1 country.
Denmark3 sites
Steno Diabetes Center Aarhus
Aarhus, 8200
Steno Diabetes Center Copenhagen
Gentofte Municipality, 2820
Steno Diabetes Center Region Sjaelland
Køge, 4600
About this study
The primary aim of the study is to prospectively monitor the risk of diabetic ketoacidosis (DKA) during treatment with sodium-glucose cotransporter 2 (SGLT2) inhibitors in type 1 diabetes after the treatment has become available as an adjunct therapy for people with type 1 diabetes.
Read the detailed description
SGLT2 inhibitors have recently been approved for treatment of type 1 diabetes. SGLT2 inhibitors affect renal glucose transport and promotes glucose excretion in the urine. This have attractive effects, notably by lowering of blood glucose without any increased risk of hypoglycemia as well as a reduction in body weight. Since the risk of hypoglycemia and weight gain during intensification of insulin treatment is a significant barrier for optimal glycemic control, SGLT2 inhibitors could be an attractive adjunct therapy in type 1 diabetes. Furthermore, SGLT2 inhibitors have beneficial cardiovascular and renal effects in persons with type 2 diabetes. This may also benefit persons with type 1 diabetes. However, the major limitation for an universal use of SGLT2 inhibitors in type 1 diabetes is a substantial increase in ketogenesis and the risk of DKA. DKA remain a substantial cause of morbidity and mortality in persons with type 1 diabetes.
Since no data exist on the risk of DKA during SGLT2 inhibition outside the randomized controlled trials, the investigators will initiate a nationwide monitoring study on the use of SGLT2 inhibitors in type 1 diabetes. This will ensure follow-up on the efficacy, safety and patient-reported outcome measures for SGLT2 inhibitors treatment of type 1 diabetes in real-world clinical practice.
- Conditions
- Diabetic Ketoacidosis
- Medical subject headings
- Diabetic Ketoacidosis
What is being measured
The primary outcome is the main question the study is designed to answer.
Diabetic ketoacidosis
Registration of incidents of DKA will be done based on data from medical records, as well as reporting from patients and registries.
Measured: 3 years
Secondary outcomes (4)
Efficacy of treatment
Data on HbA1c and total daily insulin dose will be registered from medical journals at baseline and each year at follow-up together with information on whether patients are still treated with SGLT2 inhibitors. Data on weight and hypoglycemia are obtained from patients.
Measured: 3 years
Patient reported outcome
Patients will be asked to complete the questionnaire "PAID20" (Problem Areas In Diabetes), lowest score is 0, highest score is 80. The higher score the more emotionel reactions the person with type 1 diabetes has. The second questionaire is concernig incidense of being admittet to the hospital with ketoacidosis or hypoglycemia, whether the person with type 1 diabetes has expirienced side effects or weight loss efter initiation of treatment.
Measured: 3 years
Side effects
Registration of incidence of urogenital infection will be done based on data from medical records, as well as reporting from patients and registries.
Measured: 3 years
Hypoglyceamia
Registration of incidence of hypoglycemia will be done based on data from medical records, as well as reporting from patients and registries.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2021
- Study start1 Jun 2021
- Primary completion1 Dec 2021
- Study completion1 Dec 2021
Why it stopped: Withdrawel of approvement of Dapagliflozin to type 1 diabetes
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic KetoacidosisStudies 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
- 0 participants (actual)
- Target duration
- 3 Years
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Rossing, Steno Diabetes Center Copenhagen
- Investigators
- Frederik Persson, MD, DMsc, Principal investigator, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04819178
- Sponsor's protocol ID
- 22436292
- Acronym
- RESGUE1
- Status last verified
- Feb 2022
- First submitted
- 15 Mar 2021
- Last updated
- 28 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Real Life Evaluation of SGLT2 Use in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04819178
- Acronym / sponsor ID
- RESGUE1 / 22436292
- Conditions
- Diabetic Ketoacidosis
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Withdrawel of approvement of Dapagliflozin to type 1 diabetes
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Dec 2021 (actual)
- Study completion
- 1 Dec 2021 (actual)
- First posted
- 26 Mar 2021 (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 primary aim of the study is to prospectively monitor the risk of diabetic ketoacidosis (DKA) during treatment with sodium-glucose cotransporter 2 (SGLT2) inhibitors in type 1 diabetes after the treatment has become available as an adjunct therapy for people with type 1 diabetes.
Detailed description
SGLT2 inhibitors have recently been approved for treatment of type 1 diabetes. SGLT2 inhibitors affect renal glucose transport and promotes glucose excretion in the urine. This have attractive effects, notably by lowering of blood glucose without any increased risk of hypoglycemia as well as a reduction in body weight. Since the risk of hypoglycemia and weight gain during intensification of insulin treatment is a significant barrier for optimal glycemic control, SGLT2 inhibitors could be an attractive adjunct therapy in type 1 diabetes. Furthermore, SGLT2 inhibitors have beneficial cardiovascular and renal effects in persons with type 2 diabetes. This may also benefit persons with type 1 diabetes. However, the major limitation for an universal use of SGLT2 inhibitors in type 1 diabetes is a substantial increase in ketogenesis and the risk of DKA. DKA remain a substantial cause of morbidity and mortality in persons with type 1 diabetes.
Since no data exist on the risk of DKA during SGLT2 inhibition outside the randomized controlled trials, the investigators will initiate a nationwide monitoring study on the use of SGLT2 inhibitors in type 1 diabetes. This will ensure follow-up on the efficacy, safety and patient-reported outcome measures for SGLT2 inhibitors treatment of type 1 diabetes in real-world clinical practice.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Years
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Individuals with type 1 diabetes initiated on SGLT2 inhibition will be prospectively included after provision of informed consent. We have established a national network of centers and investigators involved in the treatment of type 1 diabetes. We aim to offer inclusion in the study to every individual where SGLT2 inhibitor treatment is planned
Key inclusion criteria (1 listed)
- All patiens with type 1 diabetes on SGLT2 inhibitor treatment or where this treatment is planned.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Diabetic ketoacidosis
Time frame: 3 years
Registration of incidents of DKA will be done based on data from medical records, as well as reporting from patients and registries.
4 secondary outcomes
Efficacy of treatment
Time frame: 3 years
Patient reported outcome
Time frame: 3 years
Side effects
Time frame: 3 years
Hypoglyceamia
Time frame: 3 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Feb 2022.
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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.
Frederik Persson, MD, DMsc principal investigator
Steno Diabetes Center Copenhagen
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Diabetic Ketoacidosis, run by Steno Diabetes Center Copenhagen at 3 sites in Denmark.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 28 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Denmark. 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 was withdrawn before enrolling participants, so there are no results.
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?
Diabetic ketoacidosis (time frame: 3 years). 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 28 Feb 2022.