Type 1 DiabetesNCT03489967
Treatment of Hypoglycemia in Type 1 Diabetes
A study testing Induced-hypoglycemia test in people with Type 1 Diabetes, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.
Trial summary
According to guidelines, when a mild-to-moderate hypoglycemia occurs (capillary blood glucose < 4.0 mmol/L), 15-20g of rapidly absorbed carbohydrates should be ingested. Patients should re-test and re-ingest 15-20g carbohydrates every 15 minutes until they recover from hypoglycemia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Induced-hypoglycemia test
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteCanada
- Study dates
- 18 Apr 2018to 31 Aug 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males and females ≥ 18 years of old.
- Clinical diagnosis of type 1 diabetes for at least one year.
- Treatment with multiple daily insulin injections or insulin pump therapy and using insulin analogs (rapid, ultra-rapid and basal).
- HbA1c ≤ 10%.
Who cannot join
- Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
- Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- Known significant cardiac rhythm abnormality based on investigator judgment.
- Abnormal blood panel and/or anemia (Hb < 100g/L).
- Ongoing pregnancy or breastfeeding.
- Severe hypoglycemic episode within 1 month of screening.
- Known uncorrected hypokalemia (potassium < 3.5 mmol/L; available within the past 3 months).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Treatment of Mild-to-moderate Hypoglycemia in Adults With Type 1 Diabetes: a Validation Study
According to guidelines, when a mild-to-moderate hypoglycemia occurs (capillary blood glucose < 4.0 mmol/L), 15-20g of rapidly absorbed carbohydrates should be ingested. Patients should re-test and re-ingest 15-20g carbohydrates every 15 minutes until they recover from hypoglycemia. These recommendations were principally based on two studies conducted in the 80s before the introduction of intensive insulin therapy secondary to the DCCT trial and with insulin formulations with largely different pharmacokinetic profiles from current insulin analogs. Recent studies suggest that with current insulin analogs and intensive therapeutic approach, 15g of carbohydrates may be insufficient to rapidly correct an important proportion of hypoglycemic episodes. It is thus important to determine if the recommended hypoglycemia treatment remains the recommendation.
- Conditions
- Type 1 Diabetes
- Being tested
- Induced-hypoglycemia test
- Keywords
- Hypoglycemia, carbohydrates
- 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.
Induced-hypoglycemia testOther
Participants will be admitted at the research center at 7:00 after an overnight fast. A venous catheter will be inserted into an arm vein for blood sampling purposes. A subcutaneous insulin bolus will be administered to induce hypoglycemia. Oral treatment (16g of carbohydrates or 32g of carbohydrates) will be given when plasma glucose levels are at the target threshold of < 3.0 mmol/L or 3.0-3.5 mmol/L. Hypoglycemia symptoms will be assessed every 10 minutes by the participant using a validated scale starting from the time of insulin bolus until hypoglycemia recovery. One hour after hypoglycemia recovery, a standardized meal will be given.
| Study group | Role | What they receive |
|---|---|---|
| 16g of carbohydrates - Glucose levels < 3.0 mmol/L | Active comparator | Hypoglycemia treatment with 16g of carbohydrates will be given when glucose levels are below 3.0 mmol/L. Receives: Other: Induced-hypoglycemia test |
| 16g of carbohydrates - Glucose levels 3.0-3.5 mmol/L | Active comparator | Hypoglycemia treatment with 16g of carbohydrates will be given when glucose levels are between 3.0 and 3.5 mmol/L. Receives: Other: Induced-hypoglycemia test |
| 32g of carbohydrates - Glucose levels < 3.0 mmol/L | Active comparator | Hypoglycemia treatment with 32g of carbohydrates will be given when glucose levels are below 3.0 mmol/L Receives: Other: Induced-hypoglycemia test |
| 32g of carbohydrates - Glucose levels 3.0-3.5 mmol/L | Active comparator | Hypoglycemia treatment with 32g of carbohydrates will be given when glucose levels are between 3.0 and 3.5 mmol/L. Receives: Other: Induced-hypoglycemia test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in glucose levels 15 minutes after hypoglycemic treatment
Change in glucose levels 15 minutes after hypoglycemic treatment (16g vs. 32g of carbohydrates) when glucose levels at the time of treatment are below 3.0 mmol/L or between 3.0 and 3.5 mmol/L.
Measured: 15 minutes after hypoglycemic treatment
Secondary outcomes (28)
Change in glucose levels 20 minutes after hypoglycemic treatment
Change in glucose levels 20 minutes after hypoglycemic treatment (16g vs. 32g of carbohydrates) when glucose levels at the time of treatment are below 3.0 mmol/L or between 3.0 and 3.5 mmol/L.
Measured: 20 minutes after hypoglycemic treatment
Change in glucose levels 30 minutes after hypoglycemic treatment
Change in glucose levels 30 minutes after hypoglycemic treatment (16g vs. 32g of carbohydrates) when glucose levels at the time of treatment are below 3.0 mmol/L or between 3.0 and 3.5 mmol/L.
Measured: 30 minutes after hypoglycemic treatment
Change in glucose levels 45 minutes after hypoglycemic treatment
Change in glucose levels 45 minutes after hypoglycemic treatment (16g vs. 32g of carbohydrates) when glucose levels at the time of treatment are below 3.0 mmol/L or between 3.0 and 3.5 mmol/L.
Measured: 45 minutes after hypoglycemic treatment
Change in glucose levels 60 minutes after hypoglycemic treatment
Change in glucose levels 60 minutes after hypoglycemic treatment (16g vs. 32g of carbohydrates) when glucose levels at the time of treatment are below 3.0 mmol/L or between 3.0 and 3.5 mmol/L.
Measured: 60 minutes after hypoglycemic treatment
Number of participants with glucose levels above 8.0 mmol/L 1 hour after hypoglycemia correction
Measured: 60 minutes after hypoglycemia correction
Number of participants with glucose levels above 10.0 mmol/L 1 hour after hypoglycemia correction
Measured: 60 minutes after hypoglycemia correction
Glucose levels 60 minutes after meal consumption
Measured: 60 minutes after meal consumption
Glucose levels 90 minutes after meal consumption
Measured: 90 minutes after meal consumption
Number of patients for whom hypoglycemia was corrected 10 minutes after hypoglycemic treatment
Measured: 10 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia was corrected 15 minutes after hypoglycemic treatment
Measured: 15 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia was corrected 20 minutes after hypoglycemic treatment
Measured: 20 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia was corrected 25 minutes after hypoglycemic treatment
Measured: 25 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia was corrected 30 minutes after hypoglycemic treatment
Measured: 30 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia was corrected 35 minutes after hypoglycemic treatment
Measured: 35 minutes after hypoglycemic treatment
Number of hypoglycemic events corrected 10 minutes after hypoglycemic treatment
Measured: 10 minutes after hypoglycemic treatment
Number of hypoglycemic events corrected 15 minutes after hypoglycemic treatment
Measured: 15 minutes after hypoglycemic treatment
Number of hypoglycemic events corrected 20 minutes after hypoglycemic treatment
Measured: 20 minutes after hypoglycemic treatment
Number of hypoglycemic events corrected 25 minutes after hypoglycemic treatment
Measured: 25 minutes after hypoglycemic treatment
Number of hypoglycemic events corrected 30 minutes after hypoglycemic treatment
Measured: 30 minutes after hypoglycemic treatment
Number of hypoglycemic events corrected 35 minutes after hypoglycemic treatment
Measured: 35 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia symptoms disappeared 10 minutes after hypoglycemic treatment
Measured: 10 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia symptoms disappeared 15 minutes after hypoglycemic treatment
Measured: 15 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia symptoms disappeared 20 minutes after hypoglycemic treatment
Measured: 20 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia symptoms disappeared 25 minutes after hypoglycemic treatment
Measured: 25 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia symptoms disappeared 30 minutes after hypoglycemic treatment
Measured: 30 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia symptoms disappeared 35 minutes after hypoglycemic treatment
Measured: 35 minutes after hypoglycemic treatment
Number of patients requiring a second treatment 40 minutes after the first hypoglycemic treatment
Measured: 40 minutes after the first hypoglycemic treatment
Number of patients requiring a second treatment 15 minutes after the first hypoglycemic treatment
Measured: 15 minutes after the first hypoglycemic treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2018
- Study start18 Apr 2018
- Primary completion31 Aug 2020
- Study completion31 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institut de Recherches Cliniques de Montreal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rémi Rabasa-Lhoret, Institut de Recherches Cliniques de Montreal
- Investigators
- Remi Rabasa-Lhoret, Principal investigator, Institut de Recherches Cliniques de Montreal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03489967
- Sponsor's protocol ID
- HYPO-T
- Status last verified
- Sep 2020
- First submitted
- 9 Mar 2018
- Last updated
- 17 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Taleb N, Gingras V, Cheng R, Parent V, Messier V, Bovan D, Shohoudi A, Brazeau AS, Rabasa-Lhoret R. Non-severe hypoglycemia in type 1 diabetes: a randomized crossover trial comparing two quantities of oral carbohydrates at different insulin-induced hypoglycemia ranges. Front Endocrinol (Lausanne). 2023 Jun 2;14:1186680. doi: 10.3389/fendo.2023.1186680. eCollection 2023.
PubMed 37334295
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Mild-to-moderate Hypoglycemia in Adults With Type 1 Diabetes: a Validation Study
- ClinicalTrials.gov ID
- NCT03489967
- Acronym / sponsor ID
- HYPO-T
- Conditions
- Type 1 Diabetes
- Keywords
- Hypoglycemia, carbohydrates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Institut de Recherches Cliniques de MontrealUniversity, hospital or other
- Study start
- 18 Apr 2018 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 31 Aug 2020 (actual)
- First posted
- 6 Apr 2018 (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.
According to guidelines, when a mild-to-moderate hypoglycemia occurs (capillary blood glucose < 4.0 mmol/L), 15-20g of rapidly absorbed carbohydrates should be ingested. Patients should re-test and re-ingest 15-20g carbohydrates every 15 minutes until they recover from hypoglycemia. These recommendations were principally based on two studies conducted in the 80s before the introduction of intensive insulin therapy secondary to the DCCT trial and with insulin formulations with largely different pharmacokinetic profiles from current insulin analogs. Recent studies suggest that with current insulin analogs and intensive therapeutic approach, 15g of carbohydrates may be insufficient to rapidly correct an important proportion of hypoglycemic episodes. It is thus important to determine if the recommended hypoglycemia treatment remains the recommendation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 16g of carbohydrates - Glucose levels < 3.0 mmol/L | Active comparator | Other: Induced-hypoglycemia testHypoglycemia treatment with 16g of carbohydrates will be given when glucose levels are below 3.0 mmol/L. |
| 16g of carbohydrates - Glucose levels 3.0-3.5 mmol/L | Active comparator | Other: Induced-hypoglycemia testHypoglycemia treatment with 16g of carbohydrates will be given when glucose levels are between 3.0 and 3.5 mmol/L. |
| 32g of carbohydrates - Glucose levels < 3.0 mmol/L | Active comparator | Other: Induced-hypoglycemia testHypoglycemia treatment with 32g of carbohydrates will be given when glucose levels are below 3.0 mmol/L |
| 32g of carbohydrates - Glucose levels 3.0-3.5 mmol/L | Active comparator | Other: Induced-hypoglycemia testHypoglycemia treatment with 32g of carbohydrates will be given when glucose levels are between 3.0 and 3.5 mmol/L. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Males and females ≥ 18 years of old.
- Clinical diagnosis of type 1 diabetes for at least one year.
- Treatment with multiple daily insulin injections or insulin pump therapy and using insulin analogs (rapid, ultra-rapid and basal).
- HbA1c ≤ 10%.
Key exclusion criteria (7 listed)
- Clinically significant microvascular complications: nephropathy (estimated glomerular filtration rate below 40 ml/min), neuropathy (especially diagnosed gastroparesis) or severe proliferative retinopathy as judged by the investigator.
- Recent (< 3 months) acute macrovascular event e.g. acute coronary syndrome or cardiac surgery.
- Known significant cardiac rhythm abnormality based on investigator judgment.
- Abnormal blood panel and/or anemia (Hb < 100g/L).
- Ongoing pregnancy or breastfeeding.
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 |
|---|---|---|
| Induced-hypoglycemia testParticipants will be admitted at the research center at 7:00 after an overnight fast. A venous catheter will be inserted into an arm vein for blood sampling purposes. A subcutaneous insulin bolus will be administered to induce hypoglycemia. Oral treatment (16g of carbohydrates or 32g of carbohydrates) will be given when plasma glucose levels are at the target threshold of < 3.0 mmol/L or 3.0-3.5 mmol/L. Hypoglycemia symptoms will be assessed every 10 minutes by the participant using a validated scale starting from the time of insulin bolus until hypoglycemia recovery. One hour after hypoglycemia recovery, a standardized meal will be given. | Other | 16g of carbohydrates - Glucose levels 3.0-3.5 mmol/L, 16g of carbohydrates - Glucose levels < 3.0 mmol/L, 32g of carbohydrates - Glucose levels 3.0-3.5 mmol/L, 32g of carbohydrates - Glucose levels < 3.0 mmol/L |
Primary outcome
Change in glucose levels 15 minutes after hypoglycemic treatment
Time frame: 15 minutes after hypoglycemic treatment
Change in glucose levels 15 minutes after hypoglycemic treatment (16g vs. 32g of carbohydrates) when glucose levels at the time of treatment are below 3.0 mmol/L or between 3.0 and 3.5 mmol/L.
28 secondary outcomes
Change in glucose levels 20 minutes after hypoglycemic treatment
Time frame: 20 minutes after hypoglycemic treatment
Change in glucose levels 30 minutes after hypoglycemic treatment
Time frame: 30 minutes after hypoglycemic treatment
Change in glucose levels 45 minutes after hypoglycemic treatment
Time frame: 45 minutes after hypoglycemic treatment
Change in glucose levels 60 minutes after hypoglycemic treatment
Time frame: 60 minutes after hypoglycemic treatment
Number of participants with glucose levels above 8.0 mmol/L 1 hour after hypoglycemia correction
Time frame: 60 minutes after hypoglycemia correction
Number of participants with glucose levels above 10.0 mmol/L 1 hour after hypoglycemia correction
Time frame: 60 minutes after hypoglycemia correction
Glucose levels 60 minutes after meal consumption
Time frame: 60 minutes after meal consumption
Glucose levels 90 minutes after meal consumption
Time frame: 90 minutes after meal consumption
Number of patients for whom hypoglycemia was corrected 10 minutes after hypoglycemic treatment
Time frame: 10 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia was corrected 15 minutes after hypoglycemic treatment
Time frame: 15 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia was corrected 20 minutes after hypoglycemic treatment
Time frame: 20 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia was corrected 25 minutes after hypoglycemic treatment
Time frame: 25 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia was corrected 30 minutes after hypoglycemic treatment
Time frame: 30 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia was corrected 35 minutes after hypoglycemic treatment
Time frame: 35 minutes after hypoglycemic treatment
Number of hypoglycemic events corrected 10 minutes after hypoglycemic treatment
Time frame: 10 minutes after hypoglycemic treatment
Number of hypoglycemic events corrected 15 minutes after hypoglycemic treatment
Time frame: 15 minutes after hypoglycemic treatment
Number of hypoglycemic events corrected 20 minutes after hypoglycemic treatment
Time frame: 20 minutes after hypoglycemic treatment
Number of hypoglycemic events corrected 25 minutes after hypoglycemic treatment
Time frame: 25 minutes after hypoglycemic treatment
Number of hypoglycemic events corrected 30 minutes after hypoglycemic treatment
Time frame: 30 minutes after hypoglycemic treatment
Number of hypoglycemic events corrected 35 minutes after hypoglycemic treatment
Time frame: 35 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia symptoms disappeared 10 minutes after hypoglycemic treatment
Time frame: 10 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia symptoms disappeared 15 minutes after hypoglycemic treatment
Time frame: 15 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia symptoms disappeared 20 minutes after hypoglycemic treatment
Time frame: 20 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia symptoms disappeared 25 minutes after hypoglycemic treatment
Time frame: 25 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia symptoms disappeared 30 minutes after hypoglycemic treatment
Time frame: 30 minutes after hypoglycemic treatment
Number of patients for whom hypoglycemia symptoms disappeared 35 minutes after hypoglycemic treatment
Time frame: 35 minutes after hypoglycemic treatment
Number of patients requiring a second treatment 40 minutes after the first hypoglycemic treatment
Time frame: 40 minutes after the first hypoglycemic treatment
Number of patients requiring a second treatment 15 minutes after the first hypoglycemic treatment
Time frame: 15 minutes after the first hypoglycemic treatment
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 17 Sep 2020.
- Derived from this study: PubMed 37334295Taleb N, Gingras V, Cheng R, Parent V, Messier V, Bovan D, Shohoudi A, Brazeau AS, Rabasa-Lhoret R. Non-severe hypoglycemia in type 1 diabetes: a randomized crossover trial comparing two quantities of oral carbohydrates at different insulin-induced hypoglycemia ranges. Front Endocrinol (Lausanne). 2023 Jun 2;14:1186680. doi: 10.3389/fendo.2023.1186680. eCollection 2023.
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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.
Remi Rabasa-Lhoret principal investigator
Institut de Recherches Cliniques de Montreal
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Induced-hypoglycemia test in people with Type 1 Diabetes, run by Institut de Recherches Cliniques de Montreal at 1 site in Canada.
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 7 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 17 Sep 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 Canada. 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?
Change in glucose levels 15 minutes after hypoglycemic treatment (time frame: 15 minutes after hypoglycemic treatment). 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 NCT03489967, which also lists 1 linked publication.
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 Sep 2020.