Type 1 DiabetesPhase 4DHCL2019NCT04053712
Dual-hormone Closed-loop Glucose Control in Type 1 Diabetes
A Phase 4 study testing Glucagon and Closed-loop system in people with Type 1 Diabetes and Hypoglycemia, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.
Trial summary
Despite recent pharmacological and technological advantages, hypoglycemia remains to be the key limiting factor in achieving optimal glycemic control in people with type 1 diabetes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes, Hypoglycemia
- What is being tested?
- Glucagon and Closed-loop system
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 13 participants
- Where
- 1 siteDenmark
- Study dates
- 16 Jul 2019to 19 Mar 2021
- Phase
- Phase 4
- 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
Who may be able to join
- Age ≥ 18 years
- T1D ≥ 2 years
- Insulin pump therapy ≥ 1
- Currently treated with FiAsp® - insulin
- HbA1c ≤ 8.5% (69 mmol/mol) Exclusion criteria
- Pregnancy or nursing
Show all 21Show fewer
- Inability and willingness to comply with all protocol procedures, e.g. exercise, sleeping, blood sampling, and meal consumption
- Plan to become pregnant or sexually active and not using adequate contraceptive methods (sterilization, intrauterine device, contraceptive pill, patch or injection)
- Hypoglycemia unawareness (self-reported lack of hypoglycemia symptoms when blood glucose is < 3.0 mmol/l)
- Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during or within 30 days prior to study participation
- History of coronary artery disease or congestive heart failure
- Abnormal ECG suggestive of coronary artery disease and increased risk of malignant arrhythmia
- Allergy to glucagon or lactose
- Pheochromocytoma
- Other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation
- Withdrawal criteria
- In case of pregnancy (or desire for pregnancy), female subjects are withdrawn
- Lack of compliance to any of the important study procedures in the discretion of the investigator
- Unacceptable adverse effects in the discretion of the investigator
- Withdrawal on participants request will be accepted at any time without further justification
- Patients who complete or withdraw from the study continue their usual quarterly follow-up visits at the diabetes clinic. Withdrawal does not affect their statutory patient rights.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Despite recent pharmacological and technological advantages, hypoglycemia remains to be the key limiting factor in achieving optimal glycemic control in people with type 1 diabetes. State-of-the-art treatment for type 1 diabetes is insulin in pens or pumps that focus on reducing hyperglycemia after relative insulin deficiency e.g. after food intake. In recent years, we focused on adding low-dose glucagon to insulin therapies for the treatment and prevention of hypoglycemia - referred to as "dual-hormone treatment". We have shown that low-dose glucagon is efficient in treating mild hypoglycemia and that several factors may affect its glucose response. Our next step is to test whether the combined delivery of insulin and glucagon can improve glucose control in individuals with type 1 diabetes. In this proposal, we want to test the efficacy, safety and feasibility of a dual-hormone closed-loop system, also known as an artificial pancreas. The closed-loop system involves automatic infusion of glucagon and insulin based on continuous glucose measurements. The system will be tested in a 33-hour in-clinic study comparing the glucose control by the combined automatic delivery of insulin and glucagon with the automatic delivery of insulin-only. The study is performed at Steno Diabetes Center Copenhagen (SDCC) in collaboration with the Technical University of Denmark (DTU). We expect that the study will clarify whether low-dose glucagon added to insulin therapy can improve the glucose control in adults with type 1 diabetes. We believe that the utilization of glucagon will allow for a weight neutral optimization of glucose control, reduce risk of hypoglycemia and reduce disease burden that will reduce diabetes complications and cardiovascular diseases.
Read the detailed description
Rationale: We hypothesize that our newly developed dual-hormone insulin-glucagon closed-loop system (DCL) is safe, efficient and superior to our single-hormone insulin-only closed-loop system (SCL). The study aims to compare the glucose control achieved by DCL with our SCL.
Design: A randomized single-blinded placebo-controlled cross-over 33-hour in-clinic study of glucose control achieved with DCL versus SCL in adults and adolescents with type 1 diabetes.
Participants: 13 insulin-pump treated T1D participants will be included, if they are 15-80 years old, have T1D for ≥ 3 years, use insulin pumps with FiAsp®, and have an HbA1c≤ 8.5% (69 mmol/mol).
Procedures: In this two-phase study 1) we test the operability of our closed-loop systems and 2) compare glucose control by DCL with SCL. The two studies are identical except for the blinding procedures. In the first phase (pilot study), four participants are included, and the glucagon/saline pump is not masked. In the second phase (main study), 13 participants are included, and are as well as the investigators blinded for the content in the glucagon/saline pump.
Two days prior to study visit, a CGM (Dexcom® G6) is place on the participant's abdomen. At study visits, participants arrive in the evening at our research unit and get their insulin pump disconnected. Two study pumps (Dana Diabecare RS®, SOOIL) are attached: one pump infuses insulin (FiAsp®, Novo Nordisk) and the other infuses either glucagon (GlucaGen®, Novo Nordisk) or saline. Once a sampling cannula is placed in an antecubital vein, the study is initiated and the closed-loop system (DCL vs SCL) takes over the glucose control for the next 33 hours. Except from the control algorithm (SCL vs DCL), the study days are identical. Participants can move around freely in the clinic for 33 hours but will perform a 45-min moderate (50% VO2max) exercise session, consume three meals with variant carbohydrate content, and sleep during two overnight periods. Participants will be monitored frequently with blood samples (drawn from the antecubital vein), blood pressure, pulse, and VAS scale for nausea.
- Conditions
- Type 1 Diabetes, Hypoglycemia
- Being tested
- Glucagon, Closed-loop system
- Keywords
- Closed-loop, Dual-hormone, Glucagon, FiAsp, Artificial pancreas
- Medical subject headings
- Diabetes Mellitus, Type 1, Hypoglycemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlucagonDrug
GlucaGen(R), Novo Nordisk, DK
Closed-loop systemDevice
Closed-loop system comprise of two DANA RS (R) insulin pumps (FiAsp-GlucaGen vs FiAsp-saline), one DexCom G6 sensor, and a smartphone for the control algorithm.
| Study group | Role | What they receive |
|---|---|---|
| Single-hormone | Placebo comparator | FiAsp (R) - Saline Receives: Device: Closed-loop system |
| Dual-hormone | Active comparator | FiAsp(R) - GlucaGen(R) Receives: Drug: Glucagon; Device: Closed-loop system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of time with glucose values < 3.9 mmol/l as measured by glucose sensor
Measured: 33 hours
Number of carbohydrate interventions to treat hypoglycemia
Carbohydrate interventions are predefined and provided in case of hypoglycemia
Measured: 33 hours
Secondary outcomes (32)
Percentage of time with glucose values < 3.9 mmol/l as measured by venous plasma glucose
Calculated for the whole study period as well as for the following intervals: night 1 (23:00-07:00), night 2 (23:00-07:00), night 1 and 2, 23:00-15:00 and 15:00-07:00.
Measured: 33 hours
Percentage of participants achieving (A) time in range (3.9-10 mmol/l) > 70 %, (B) time in alert hypoglycemia (<3.9 mmol/l) < 4 %, and (C) time in clinical hypoglycemia (<3.0 mmol) < 1% as measured by glucose sensor and venous plasma glucose
A composite outcome will be calculated for the whole study period as well as for the following intervals: night 1 (23:00-07:00), night 2 (23:00-07:00), night 1 and 2, 23:00-15:00 and 15:00-07:00.
Measured: 33 hours
Mean blood glucose value measured by glucose sensor and venous plasma glucose
Calculated for the whole study period as well as for the following intervals: night 1 (23:00-07:00), night 2 (23:00-07:00), night 1 and 2, 23:00-15:00 and 15:00-07:00.
Measured: 33 hours
Percentage of time with glucose values in the range 3.9-8.0 mmol/l measured by glucose sensor and venous plasma glucose
Calculated for the whole study period as well as for the following intervals: night 1 (23:00-07:00), night 2 (23:00-07:00), night 1 and 2, 23:00-15:00 and 15:00-07:00.
Measured: 33 hours
Percentage of time with glucose values in the range 3.9-10.0 mmol/l measured by glucose sensor and venous plasma glucose
Calculated for the whole study period as well as for the following intervals: night 1 (23:00-07:00), night 2 (23:00-07:00), night 1 and 2, 23:00-15:00 and 15:00-07:00.
Measured: 33 hours
Percentage of time with glucose values in the range > 13.9 measured by glucose sensor and venous plasma glucose
Calculated for the whole study period as well as for the following intervals: night 1 (23:00-07:00), night 2 (23:00-07:00), night 1 and 2, 23:00-15:00 and 15:00-07:00.
Measured: 33 hours
Percentage of time with glucose values < 3.0 mmol/l as measured by glucose sensor and venous plasma glucose
Calculated for the whole study period as well as for the following intervals: night 1 (23:00-07:00), night 2 (23:00-07:00), night 1 and 2, 23:00-15:00 and 15:00-07:00.
Measured: 33 hours
Number of hypoglycemic episodes (<3.9 mmol/l and <3.0 mmol/l) overnight and during daytime
Measured: 33 hours
Nadir blood glucose value for each hypoglycemic episode as measured by glucose sensor and venous plasma glucose
Measured: 33 hours
Glucose sensor glycemic variability measured as SD and CV during overnight and during daytime
Calculated for the whole study period as well as for the following intervals: night 1 (23:00-07:00), night 2 (23:00-07:00), night 1 and 2, 23:00-15:00 and 15:00-07:00.
Measured: 33 hours
Low Blood Glucose Index (LBGI) overnight and during daytime by glucose sensor and venous plasma glucose
Calculated for the whole study period as well as for the following intervals: night 1 (23:00-07:00), night 2 (23:00-07:00), night 1 and 2, 23:00-15:00 and 15:00-07:00.
Measured: 33 hours
Percentage of participants with a mean blood glucose value (glucose sensor and venous plasma glucose) ≤ 8.6 mmol/l (corresponding to an estimated HbA1c of 7.0% / 53 mmol/mol)
Measured: 33 hours
Percentage of patients with a mean blood glucose value (glucose sensor and venous plasma glucose) ≤ their standard therapy mean glucose value (calculated based on HbA1c measurement)
Measured: 33 hours
Mean Absolute Relative Difference (MARD) between glucose sensor and venous plasma glucose
Participants have two glucose sensors during the study
Measured: 33 hours
Percentages of values between glucose sensor and venous plasma glucose in zone A, B, C, D and E in the Clarke Error Grid analysis.
Participants have two glucose sensors during the study. One sensor closed to the infusion of glucagon.
Measured: 33 hours
Mean blood pressure over the study period (mmHG)
Blood pressure and pulse taken at predefined timepoints
Measured: 33 hours
Mean pulse rate over the study period (beats per min)
Blood pressure and pulse taken at predefined timepoints
Measured: 33 hours
Mean nausea level measured with a visual analog scale (VAS range: 0-10)
Calculated for the whole study period as well as for the following intervals: night 1 (23:00-07:00), night 2 (23:00-07:00), night 1 and 2, 23:00-15:00 and 15:00-07:00.
Measured: 33 hours
Total insulin dose per study day (UI)
Measured: 33 hours
Total time of insulin suspension per study day (UI)
Measured: 33 hours
Total glucagon dose per study day (microgram)
the outcome will be calculated for the whole study period as well as for the following intervals: night 1 (23:00-07:00), night 2 (23:00-07:00), night 1 and 2, 23:00-15:00 and 15:00-07:00.
Measured: 33 hours
Mean plasma glucagon
the outcome will be calculated for the whole study period as well as for the following intervals: night 1 (23:00-07:00), night 2 (23:00-07:00), night 1 and 2, 23:00-15:00 and 15:00-07:00.
Measured: 33 hours
Mean plasma insulin aspart
the outcome will be calculated for the whole study period as well as for the following intervals: night 1 (23:00-07:00), night 2 (23:00-07:00), night 1 and 2, 23:00-15:00 and 15:00-07:00.
Measured: 33 hours
Difference in participant estimated grams of carbohydrate and actual carbohydrate in study meals
Meals presented at the study will be estimated for carbohydrate content by the participant on
Measured: 33 hours
Difference in participant estimated blood glucose level and plasma glucose level at predefined timepoints
Self-assessment of glucose levels (Clarke Error Grid)
Measured: 33 hours
Total energy expenditure during the study visit (kcal/kg) measured by ActiGraph GT9X Link
Freedson and Sasaki MET prediction equations to determine energy expenditure in MET
Measured: 33 hours
Steps taken during the study visit measured by ActiGraph GT9X Link
Measured: 33 hours
Minutes per study day (min/d) spent in different levels of activity (sedentary, light, moderate, vigorous, or MVPA) measured by ActiGraph GT9X Link
Measured: 45 min
Minutes between lights off and the first sleep episode (Sleep latency) measured by ActiGraph GT9X Link
Measured: 14 hours
Total sleep time measured by ActiGraph GT9X Link
Minutes between sleep onset and wake time
Measured: 14 hours
The percentage of time asleep from lights off to lights on (sleep efficiency) measured by ActiGraph GT9X Link
Measured: 14 hours
Mean Borg scale level during exercise (RANGE:0-10)
Assessed every 5-10 minutes during bicycling
Measured: 45 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2019
- Study start16 Jul 2019
- Primary completion19 Mar 2021
- Study completion19 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- A randomized single-blinded placebo-controlled cross-over 33-hour in-clinic study in adults with type 1 diabetes.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Steno Diabetes Center Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Technical University of Denmark, University of Copenhagen, Danish Diabetes Academy
- Responsible party
- Sponsor
- Investigators
- Ajenthen G Ranjan, MD, PhD, Principal investigator, Steno Diabetes Center Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04053712
- Sponsor's protocol ID
- H-19026331
- Other IDs
- 2019-001631-31, 2019043528, 2019043269, CIV-19-04-028465, 2019
- Acronym
- DHCL2019
- Status last verified
- Aug 2022
- First submitted
- 8 Aug 2019
- Last updated
- 18 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual-hormone Closed-loop Glucose Control in Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04053712
- Acronym / sponsor ID
- DHCL2019 / H-19026331
- Conditions
- Type 1 Diabetes, Hypoglycemia
- Keywords
- Closed-loop, Dual-hormone, Glucagon, FiAsp, Artificial pancreas
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Steno Diabetes Center CopenhagenUniversity, hospital or other
- Collaborators
- Technical University of Denmark, University of Copenhagen, Danish Diabetes Academy
- Study start
- 16 Jul 2019 (actual)
- Primary completion
- 19 Mar 2021 (actual)
- Study completion
- 19 Mar 2021 (actual)
- First posted
- 12 Aug 2019 (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.
Despite recent pharmacological and technological advantages, hypoglycemia remains to be the key limiting factor in achieving optimal glycemic control in people with type 1 diabetes. State-of-the-art treatment for type 1 diabetes is insulin in pens or pumps that focus on reducing hyperglycemia after relative insulin deficiency e.g. after food intake. In recent years, we focused on adding low-dose glucagon to insulin therapies for the treatment and prevention of hypoglycemia - referred to as "dual-hormone treatment". We have shown that low-dose glucagon is efficient in treating mild hypoglycemia and that several factors may affect its glucose response. Our next step is to test whether the combined delivery of insulin and glucagon can improve glucose control in individuals with type 1 diabetes. In this proposal, we want to test the efficacy, safety and feasibility of a dual-hormone closed-loop system, also known as an artificial pancreas. The closed-loop system involves automatic infusion of glucagon and insulin based on continuous glucose measurements. The system will be tested in a 33-hour in-clinic study comparing the glucose control by the combined automatic delivery of insulin and glucagon with the automatic delivery of insulin-only. The study is performed at Steno Diabetes Center Copenhagen (SDCC) in collaboration with the Technical University of Denmark (DTU). We expect that the study will clarify whether low-dose glucagon added to insulin therapy can improve the glucose control in adults with type 1 diabetes. We believe that the utilization of glucagon will allow for a weight neutral optimization of glucose control, reduce risk of hypoglycemia and reduce disease burden that will reduce diabetes complications and cardiovascular diseases.
Detailed description
Rationale: We hypothesize that our newly developed dual-hormone insulin-glucagon closed-loop system (DCL) is safe, efficient and superior to our single-hormone insulin-only closed-loop system (SCL). The study aims to compare the glucose control achieved by DCL with our SCL.
Design: A randomized single-blinded placebo-controlled cross-over 33-hour in-clinic study of glucose control achieved with DCL versus SCL in adults and adolescents with type 1 diabetes.
Participants: 13 insulin-pump treated T1D participants will be included, if they are 15-80 years old, have T1D for ≥ 3 years, use insulin pumps with FiAsp®, and have an HbA1c≤ 8.5% (69 mmol/mol).
Procedures: In this two-phase study 1) we test the operability of our closed-loop systems and 2) compare glucose control by DCL with SCL. The two studies are identical except for the blinding procedures. In the first phase (pilot study), four participants are included, and the glucagon/saline pump is not masked. In the second phase (main study), 13 participants are included, and are as well as the investigators blinded for the content in the glucagon/saline pump.
Two days prior to study visit, a CGM (Dexcom® G6) is place on the participant's abdomen. At study visits, participants arrive in the evening at our research unit and get their insulin pump disconnected. Two study pumps (Dana Diabecare RS®, SOOIL) are attached: one pump infuses insulin (FiAsp®, Novo Nordisk) and the other infuses either glucagon (GlucaGen®, Novo Nordisk) or saline. Once a sampling cannula is placed in an antecubital vein, the study is initiated and the closed-loop system (DCL vs SCL) takes over the glucose control for the next 33 hours. Except from the control algorithm (SCL vs DCL), the study days are identical. Participants can move around freely in the clinic for 33 hours but will perform a 45-min moderate (50% VO2max) exercise session, consume three meals with variant carbohydrate content, and sleep during two overnight periods. Participants will be monitored frequently with blood samples (drawn from the antecubital vein), blood pressure, pulse, and VAS scale for nausea.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- A randomized single-blinded placebo-controlled cross-over 33-hour in-clinic study in adults with type 1 diabetes.
| Arm | Type | Receives |
|---|---|---|
| Single-hormone | Placebo comparator | Device: Closed-loop systemFiAsp (R) - Saline |
| Dual-hormone | Active comparator | Drug: Glucagon, Device: Closed-loop systemFiAsp(R) - GlucaGen(R) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- Age ≥ 18 years
- T1D ≥ 2 years
- Insulin pump therapy ≥ 1
- Currently treated with FiAsp® - insulin
- HbA1c ≤ 8.5% (69 mmol/mol) Exclusion criteria
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| GlucagonGlucaGen(R), Novo Nordisk, DK | Drug | Dual-hormone |
| Closed-loop systemClosed-loop system comprise of two DANA RS (R) insulin pumps (FiAsp-GlucaGen vs FiAsp-saline), one DexCom G6 sensor, and a smartphone for the control algorithm. | Device | Dual-hormone, Single-hormone |
Primary outcome
Percentage of time with glucose values < 3.9 mmol/l as measured by glucose sensor
Time frame: 33 hours
Number of carbohydrate interventions to treat hypoglycemia
Time frame: 33 hours
Carbohydrate interventions are predefined and provided in case of hypoglycemia
32 secondary outcomes
Percentage of time with glucose values < 3.9 mmol/l as measured by venous plasma glucose
Time frame: 33 hours
Percentage of participants achieving (A) time in range (3.9-10 mmol/l) > 70 %, (B) time in alert hypoglycemia (<3.9 mmol/l) < 4 %, and (C) time in clinical hypoglycemia (<3.0 mmol) < 1% as measured by glucose sensor and venous plasma glucose
Time frame: 33 hours
Mean blood glucose value measured by glucose sensor and venous plasma glucose
Time frame: 33 hours
Percentage of time with glucose values in the range 3.9-8.0 mmol/l measured by glucose sensor and venous plasma glucose
Time frame: 33 hours
Percentage of time with glucose values in the range 3.9-10.0 mmol/l measured by glucose sensor and venous plasma glucose
Time frame: 33 hours
Percentage of time with glucose values in the range > 13.9 measured by glucose sensor and venous plasma glucose
Time frame: 33 hours
Percentage of time with glucose values < 3.0 mmol/l as measured by glucose sensor and venous plasma glucose
Time frame: 33 hours
Number of hypoglycemic episodes (<3.9 mmol/l and <3.0 mmol/l) overnight and during daytime
Time frame: 33 hours
Nadir blood glucose value for each hypoglycemic episode as measured by glucose sensor and venous plasma glucose
Time frame: 33 hours
Glucose sensor glycemic variability measured as SD and CV during overnight and during daytime
Time frame: 33 hours
Low Blood Glucose Index (LBGI) overnight and during daytime by glucose sensor and venous plasma glucose
Time frame: 33 hours
Percentage of participants with a mean blood glucose value (glucose sensor and venous plasma glucose) ≤ 8.6 mmol/l (corresponding to an estimated HbA1c of 7.0% / 53 mmol/mol)
Time frame: 33 hours
Percentage of patients with a mean blood glucose value (glucose sensor and venous plasma glucose) ≤ their standard therapy mean glucose value (calculated based on HbA1c measurement)
Time frame: 33 hours
Mean Absolute Relative Difference (MARD) between glucose sensor and venous plasma glucose
Time frame: 33 hours
Percentages of values between glucose sensor and venous plasma glucose in zone A, B, C, D and E in the Clarke Error Grid analysis.
Time frame: 33 hours
Mean blood pressure over the study period (mmHG)
Time frame: 33 hours
Mean pulse rate over the study period (beats per min)
Time frame: 33 hours
Mean nausea level measured with a visual analog scale (VAS range: 0-10)
Time frame: 33 hours
Total insulin dose per study day (UI)
Time frame: 33 hours
Total time of insulin suspension per study day (UI)
Time frame: 33 hours
Total glucagon dose per study day (microgram)
Time frame: 33 hours
Mean plasma glucagon
Time frame: 33 hours
Mean plasma insulin aspart
Time frame: 33 hours
Difference in participant estimated grams of carbohydrate and actual carbohydrate in study meals
Time frame: 33 hours
Difference in participant estimated blood glucose level and plasma glucose level at predefined timepoints
Time frame: 33 hours
Total energy expenditure during the study visit (kcal/kg) measured by ActiGraph GT9X Link
Time frame: 33 hours
Steps taken during the study visit measured by ActiGraph GT9X Link
Time frame: 33 hours
Minutes per study day (min/d) spent in different levels of activity (sedentary, light, moderate, vigorous, or MVPA) measured by ActiGraph GT9X Link
Time frame: 45 min
Minutes between lights off and the first sleep episode (Sleep latency) measured by ActiGraph GT9X Link
Time frame: 14 hours
Total sleep time measured by ActiGraph GT9X Link
Time frame: 14 hours
The percentage of time asleep from lights off to lights on (sleep efficiency) measured by ActiGraph GT9X Link
Time frame: 14 hours
Mean Borg scale level during exercise (RANGE:0-10)
Time frame: 45 min
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 18 Aug 2022.
- Individual participant dataSharing planned: Yes
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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.
Ajenthen G Ranjan, MD, PhD principal investigator
Steno Diabetes Center Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glucagon and Closed-loop system in people with Type 1 Diabetes and Hypoglycemia, run by Steno Diabetes Center Copenhagen at 1 site 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 21 inclusion and 0 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 18 Aug 2022. 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 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Percentage of time with glucose values < 3.9 mmol/l as measured by glucose sensor (time frame: 33 hours). The study lists 2 primary outcomes in all. 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 18 Aug 2022.