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Type 1 DiabetesRaSlo-19NCT04098549

The Effect of Rapid and Slow Glucose Fall on the Subsequent Glucose Production in People With Type 1 Diabetes

A study testing Rapid lowering of plasma glucose and Slow lowering of plasma glucose in people with Type 1 Diabetes and Blood Glucose, Low, run by Steno Diabetes Center Copenhagen at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

In the effort of better understanding the glucose control in people with type 1 diabetes, in-depth insight into the physiology of hepatic glucose production and its influencing factors is essential. Read more about this study

Who is it for?
Ages 18 to 70 years
What is being tested?
Rapid lowering of plasma glucose and Slow lowering of plasma glucose
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteDenmark
Study dates
12 Sep 2019to 15 Jan 2020
Phase
Interventional
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age 18-70 years
  • Duration of Type 1 Diabetes ≥ 3 years
  • Insulin pump use > 6 months

Who cannot join

  • Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start
  • Allergy or intolerance to lactose or GlucaGen (Novo Nordisk, Bagsværd, DK)
  • Use of medications that are known to cause QT interval prolongation
  • Females who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods
  • Females who have different basal insulin pattern depending on their menstrual cycle
  • Inability to understand the individual information and to give informed consent
  • Current participation in another clinical trial that, in the judgment of the principle investigator, will compromise the results of the study or the safety of the subject
  • Other concomitant medical or psychological condition that according to the investigator's assessment makes the individual unsuitable for study participation

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Steno Diabetes Center Copenhagen

    Gentofte Municipality, 2820

Other trials in Denmark

About this study

In the effort of better understanding the glucose control in people with type 1 diabetes, in-depth insight into the physiology of hepatic glucose production and its influencing factors is essential. Previously, a number of potential influencing factors of hepatic glucose production have been investigated, including insulin-on-board, low carbohydrate diet, preceding ethanol intake, exercise and multiple stimulations of hepatic glucose production. Previous post-hoc analysis of dual-hormone closed-loop systems has indicated that the rate of fall in blood glucose influences the following stimulation of hepatic glucose response. However, the rate of fall in blood glucose is highly related to insulin levels, which may explain those findings. Thus, in this study the investigators want to examine whether the different rates of fall in blood glucose with similar insulin levels on board affect the hepatic glucose response in individuals with type 1 diabetes. In the study, which will be conducted at Steno Diabetes Center Copenhagen, participants will complete two study visits. On each visit, a hypoglycemic clamp technique will be used to lower the blood glucose levels of the participants (using either a rapid or slow decline rate), whereupon hepatic glucose production will be stimulated using low-dose glucagon. The study days are divided into four phases: 1) preparation phase, 2) hyperinsulinemic euglycemic phase (stabilization of blood glucose), 3) hyperinsulinemic hypoglycemic phase (rapid or slow decline in blood glucose) and 4) post-glucagon administration phase. This design will allow the investigators to examine whether differences in hepatic glucose response exist depending on preceding rate of fall in blood glucose. We hypothesize that the rate of fall in blood glucose does not affect the hepatic glucose production.

Being tested
Rapid lowering of plasma glucose, Slow lowering of plasma glucose
Keywords
Type 1 Diabetes, Glucose Metabolism, Hypoglycemia, Glucagon
Medical subject headings
Diabetes Mellitus, Type 1, Glucose Metabolism Disorders, Hypoglycemia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Rapid lowering of plasma glucoseOther

    Rapid lowering of plasma glucose using hypoglycemic clamp technique

  • Slow lowering of plasma glucoseOther

    Slow lowering of plasma glucose using hypoglycemic clamp technique

Study groups in NCT04098549
Study groupRoleWhat they receive
Rapid-SlowExperimentalThis arm will begin with intervention "rapid" (rapid rate of fall in plasma glucose) for the first study visit and proceed to intervention "slow" (slow rate of fall in plasma glucose) for the second study visit.
Receives: Other: Rapid lowering of plasma glucose; Other: Slow lowering of plasma glucose
Slow-RapidExperimentalThis arm will begin with intervention "slow" (slow rate of fall in plasma glucose) for the first study visit and proceed to intervention "rapid" (rapid rate of fall in plasma glucose) for the second study visit.
Receives: Other: Rapid lowering of plasma glucose; Other: Slow lowering of plasma glucose

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Positive incremental area under the glucose curve (PI-AUC) (using the plasma glucose concentration before glucagon administration as basal level)

    Measured: from 0-120 minutes after glucagon administration

Secondary outcomes (19)

  1. Total area under the glucose curve (AUC)

    Measured: from 0-120 minutes after glucagon administration

  2. Peak plasma glucose

    Measured: from 0-120 minutes after glucagon administration

  3. Incremental plasma glucose peak

    Measured: from 0-120 minutes after glucagon administration

  4. Time-to-peak plasma glucose

    Measured: from 0-120 minutes after glucagon administration

  5. Plasma glucose level

    Measured: 120 minutes after glucagon administration

  6. Duration of plasma glucose above 4.0 mmol/l

    Measured: from 0-120 minutes after glucagon administration

  7. Duration of plasma glucose above baseline

    Measured: from 0-120 minutes after glucagon administration

  8. Number of subjects who, after reaching a plasma glucose value > 3.9 mmol/l following glucagon administration, maintain a plasma glucose level in the range of 3.9-10 mmol/l

    Measured: throughout phase 4 (until 120 minutes after glucagon administration)

  9. Number of subjects who, after reaching a PG > 3.9 mmol/l following glucagon administration, maintain a plasma glucose level in the range of 3.9-7.8 mmol/l

    Measured: throughout phase 4 (until 120 minutes after glucagon administration)

  10. Time from glucagon administration to reaching a plasma glucose level > 3,9 mmol/l

    Measured: from 0-120 minutes after glucagon administration

  11. Duration of a plasma glucose level in the range of 3.9-10 mmol/l

    Measured: from 0-120 minutes after glucagon administration

  12. Duration of a plasma glucose level in the range of 3.9-7.8 mmol/l

    Measured: from 0-120 minutes after glucagon administration

  13. Change in insulin levels (measured as area under the curve)

    Measured: 0-120 minutes after glucagon administration

  14. Change in insulin levels (measured as peak change)

    Measured: from baseline to 120 minutes after glucagon administration

  15. Change in glucagon levels (measured as area under the curve)

    Measured: 0-120 minutes after glucagon administration

  16. Change in glucagon levels (measured as peak change)

    Measured: 0-120 minutes after glucagon administration

  17. Average changes in Edinburgh Hypoglycemia Scale

    Measured: measured at baseline, 5 minutes prior to the end of phase 2, 5 minutes prior to the end of phase 3 and 30 and 115 minutes after glucagon administration

  18. Average change in visual analogue scale score for nausea, headache, stomach ache and palpitations

    Measured: measured at baseline, 5 minutes prior to the end of phase 2, 5 minutes prior to the end of phase 3 and 30 and 115 minutes after glucagon administration

  19. Number of subjects experiencing vomiting

    Measured: from 0-120 minutes after glucagon administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Sep 2019
  2. Study start12 Sep 2019
  3. Primary completion15 Jan 2020
  4. Study completion15 Jan 2020

Resources

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 N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Crossover
Masking
Single blind
Who is masked
Participant
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04098549
Sponsor's protocol ID
H-19034585
Acronym
RaSlo-19
Status last verified
Jun 2020
First submitted
11 Sep 2019
Last updated
25 Jun 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Questions about this trial

What is this clinical trial studying?

A study testing Rapid lowering of plasma glucose and Slow lowering of plasma glucose in people with Type 1 Diabetes and Blood Glucose, Low, 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 3 inclusion and 8 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 25 Jun 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 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 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?

Positive incremental area under the glucose curve (PI-AUC) (using the plasma glucose concentration before glucagon administration as basal level) (time frame: from 0-120 minutes after glucagon administration). 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 NCT04098549.

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 25 Jun 2020.

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