Fasting HypoglycemiaNCT03970772
Mini-Dose Glucagon to Treat Fasting-induced Hypoglycemia During Ramadan
A study testing Glucagon Injection and Glucose Tablets in people with Fasting Hypoglycemia and Diabetes Mellitus, Type 1, run by Qassim University at 1 site in Saudi Arabia.
Trial summary
This study aimed to develop a new approach for the treatment of fasting induced hypoglycemia during ramadan using mini-dose glucagon. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Fasting Hypoglycemia, Diabetes Mellitus, Type 1
- What is being tested?
- Glucagon Injection and Glucose Tablets
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 15 Apr 2019to 15 Aug 2019
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical diagnosis of T1DM using daily insulin
- 18.0 to < 65.0 years of age with body mass index 20.0 to <35.0 kg/m2.
- Having diabetes for ≥2.0 years
- HbA1c <8.5%
- Has a smart phone with access to the internet and welling to upload data during the study period.
- Welling to wear a devise such as continuous glucose monitor ≥6 days/week.
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- Females, not currently known to be pregnant
- In good general health as evaluated by investigator based on available clinical data
- Willing to comply to the protocol requirements for the duration of the study
Who cannot join
- Any history of more than one severe hypoglycemic episode (need assistance by third party) in the past 12 months
- Any history of more than one episode of diabetic ketoacidosis in the past 12 months
- Female pregnant or planning to get pregnant.
- Use of any of the following medications: oral hypoglycemic agents, systemic corticosteroids or beta-blocker, theophylline, beta-adrenergic agonists, 1st generation anticholinergic drugs.
- History of hypersensitivity to glucagon or severe hypersensitivity reactions (such as angioedema) to any other medications
- History of uncontrolled hypertension (systolic BP >160 mmHg or diastolic BP >100 mmHg)
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- History of seizure disorder.
- Presence of any of conditions based on judgment of the investigator that could affect or interfere with the response, absorption, metabolism or execration of glucagon.
- Currently following any kind of weight-loss diet
- Currently participation in another clinical trials
Trial locations and contacts
1 site in 1 country.
About this study
This study aimed to develop a new approach for the treatment of fasting induced hypoglycemia during ramadan using mini-dose glucagon.
Read the detailed description
This study aimed to understand whether subcutaneously-given mini-dose glucagon (MDG) as an alternative to carbohydrate consumption could avert hypoglycemia or treat it effectively in type 1 diabetes patients who choose to fast during Ramadan in observance of their faith. This treatment method could also avert any negative psychological emotions Muslim people with diabetes may experience by ingesting carbohydrates to control hypoglycemia, thereby breaking their fast. Furthermore, it could improve ability to self-manage fasting, which is an important action for their spiritual and overall wellbeing.
There will be two phases included in this study:
- Pre-crossover Phase: Before starting the crossover trial, a pre-crossover phase will conduct to evaluate hypoglycemia eligibility, frequency and compliance.
- Crossover Trial Phase:
The Crossover Trial Phase will include 20 participants and consist of two (2-weeks) periods. Participants who don't develop any hypoglycemic event or failed to complete both periods will be excluded.
Participants will be randomized into two groups:
- Group A in periods one will use MDG and glucose tablets in period two according to the protocol.
- Group B in periods one will use glucose tablets and MDG in period two according to the protocol.
The primary outcome will be the number of treated fasting induced hypoglycemic events.
- Conditions
- Fasting Hypoglycemia, Diabetes Mellitus, Type 1
- Being tested
- Glucagon Injection, Glucose Tablets
- Keywords
- Type 1 diabetes mellitus, Fasting, Ramadan, Glucagon, Mini-dose, Hypoglycemia
- Medical subject headings
- Hypoglycemia, Diabetes Mellitus, Type 1, Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glucagon InjectionDrug
Participants will be instructed to check their blood glucose (BG) with study meter once they developed hypoglycemia symptoms, their CGM reads below 70 mg/dl, or when the CGM glucose was trending down and the participant intended to treat to prevent hypoglycemia. Participants will be instructed to check BG with meter 3 times and treat the hypoglycemia event using mini-dose glucagon when their BG in range 40-69 mg/dl according a prescribed protocol.
Glucose TabletsOther
Participants will be instructed to check their blood glucose (BG) with study meter once they developed hypoglycemia symptoms, their CGM reads below 70 mg/dl, or when the CGM glucose was trending down and the participant intended to treat to prevent hypoglycemia. Participants will be instructed to check BG with meter 3 times and treat the hypoglycemia event using glucose tablets when their BG in range 40-69 mg/dl according a prescribed protocol.
| Study group | Role | What they receive |
|---|---|---|
| Glucagon injection | Experimental | Dilute Glucagon (1 mg/ml) Receives: Drug: Glucagon Injection |
| Glucose tablets | Active comparator | Dextrose glucose tablets Receives: Other: Glucose Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in glucose values from baseline to 30 minute
The change in blood glucose from baseline to 30 minute following treatment of hypoglycemic events
Measured: 30 minutes
Secondary outcomes (19)
Events approached 100 mg/dL or increased by 30 mg/dL
During the first hour following each hypoglycemic event (BG 50-69 mg/dL), the investigators will record the events approached 100 mg/dL or increased by 30 mg/dL
Measured: 60 Minutes
Treatment success from first dose
During the first hour following each hypoglycemic event (BG 50-69 mg/dL), the investigators will record the events with blood glucose concentration ≥50 mg/dl 15 minute AND ≥70 mg/dl 30 minute after the initial treatment of a hypoglycemic event
Measured: 60 Minutes
Mean Glucose Value, during hypoglycemia event by CGM
During the first hour following each hypoglycemic event (BG 50-69 mg/dL), the investigators will calculate the mean glucose value from CGM data
Measured: 60 Minutes
Time in Range, during hypoglycemia event by CGM
During the first hour following each hypoglycemic event (BG 50-69 mg/dL), the investigators will calculate the percentage of time in range 70-180 mg/dL from CGM data.
Measured: 60 Minutes
Time spend below 70 mg/dL, during hypoglycemia event by CGM
During the first hour following each hypoglycemic event (BG 50-69 mg/dL), the investigators will calculate the percentage of time <70 mg/dL from CGM data.
Measured: 60 Minutes
Minimum Glucose, during hypoglycemia event by CGM
During the first two hour following each hypoglycemic event (BG 50-69 mg/dL), the investigators will record the minimum glucose value from CGM data.
Measured: 60 Minutes
Maximum Glucose, during hypoglycemia event by CGM
During the first two hour following each hypoglycemic event (BG 50-69 mg/dL), the investigators will record the maximum glucose value from CGM data.
Measured: 60 Minutes
Mean Glucose Value, during hypoglycemia event by CGM
During the first two hour following each hypoglycemic event (BG 50-69 mg/dL), the investigators will calculate the mean glucose value from CGM data
Measured: 120 Minutes
Time in Range, during hypoglycemia event by CGM
During the first two hour following each hypoglycemic event (BG 50-69 mg/dL), the investigators will calculate the percentage of time in range 70-180 mg/dL from CGM data
Measured: 120 Minutes
Time spend below 70 mg/dL, during hypoglycemia event by CGM
During the first two hour following each hypoglycemic event (BG 50-69 mg/dL), the investigators will calculate the percentage of time <70 mg/dL from CGM data
Measured: 120 Minutes
Minimum Glucose, during hypoglycemia event by CGM
During the first two hour following each hypoglycemic event (BG 50-69 mg/dL), the investigators will record the minimum glucose value from CGM data.
Measured: 120 Minutes
Maximum Glucose, during hypoglycemia event by CGM
During the first two hour following each hypoglycemic event (BG 50-69 mg/dL), the investigators will record the maximum glucose value from CGM data.
Measured: 120 Minutes
The proportion of completion of fasts
The proportion of completion of fasts following treatment of hypoglycemic events
Measured: 2 Weeks
Mean Glucose Value, by CGM
During the entire two weeks of intervention/comparator period, the investigators will calculate the mean glucose value from CGM data
Measured: 2 Weeks
Time in Range, by CGM
During the entire two weeks of intervention/comparator period, the investigators will calculate the percentage of time in range 70-180 mg/dL from CGM data
Measured: 2 Weeks
Time spend below 70 mg/dL, by CGM
During the entire two weeks of intervention/comparator period, the investigators will calculate the percentage of time <70 mg/dL from CGM data
Measured: 2 Weeks
Time spend above 180 mg/dL, by CGM
During the entire two weeks of intervention/comparator period, the investigators will calculate the percentage of time >180 mg/dL from CGM data
Measured: 2 Weeks
Time spend above 250 mg/dL, by CGM
During the entire two weeks of intervention/comparator period, the investigators will calculate the percentage of time >250 mg/dL from CGM data
Measured: 2 Weeks
Coefficient of Variation, by CGM
During the entire two weeks of intervention/comparator period, the investigators will calculate the Coefficient of Variation from CGM data
Measured: 2 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jun 2019
- Study start15 Apr 2019
- Primary completion10 Jun 2019
- Study completion15 Aug 2019
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 Fasting HypoglycemiaStudies 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
- Model description
- This is a Randomize Crossover study with a pre-crossover phase and a crossover trial phase, which will include a minimum of 20 participants and consist of two (2-weeks) periods.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Qassim University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Metab Algeffari, Qassim University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03970772
- Sponsor's protocol ID
- med-2019-2-2-I-5389
- Status last verified
- Jul 2021
- First submitted
- 29 May 2019
- Last updated
- 15 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Algeffari M, Hussain S, Almogbel T, Alsharidah M, Alghadouni H, Mahmood F. Home Use of Mini-Dose Glucagon As a Novel Treatment for Hypoglycemia Following Repeated, Prolonged Fasts in Type 1 Diabetes During Ramadan. Diabetes Care. 2022 Apr 1;45(4):990-993. doi: 10.2337/dc21-1655.
PubMed 35176134
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mini-Dose Glucagon to Treat Fasting-induced Hypoglycemia During Ramadan
- ClinicalTrials.gov ID
- NCT03970772
- Acronym / sponsor ID
- med-2019-2-2-I-5389
- Conditions
- Fasting Hypoglycemia, Diabetes Mellitus, Type 1
- Keywords
- Type 1 diabetes mellitus, Fasting, Ramadan, Glucagon, Mini-dose, Hypoglycemia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Qassim UniversityUniversity, hospital or other
- Study start
- 15 Apr 2019 (actual)
- Primary completion
- 10 Jun 2019 (actual)
- Study completion
- 15 Aug 2019 (actual)
- First posted
- 3 Jun 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.
This study aimed to develop a new approach for the treatment of fasting induced hypoglycemia during ramadan using mini-dose glucagon.
Detailed description
This study aimed to understand whether subcutaneously-given mini-dose glucagon (MDG) as an alternative to carbohydrate consumption could avert hypoglycemia or treat it effectively in type 1 diabetes patients who choose to fast during Ramadan in observance of their faith. This treatment method could also avert any negative psychological emotions Muslim people with diabetes may experience by ingesting carbohydrates to control hypoglycemia, thereby breaking their fast. Furthermore, it could improve ability to self-manage fasting, which is an important action for their spiritual and overall wellbeing.
There will be two phases included in this study:
- Pre-crossover Phase: Before starting the crossover trial, a pre-crossover phase will conduct to evaluate hypoglycemia eligibility, frequency and compliance.
- Crossover Trial Phase:
The Crossover Trial Phase will include 20 participants and consist of two (2-weeks) periods. Participants who don't develop any hypoglycemic event or failed to complete both periods will be excluded.
Participants will be randomized into two groups:
- Group A in periods one will use MDG and glucose tablets in period two according to the protocol.
- Group B in periods one will use glucose tablets and MDG in period two according to the protocol.
The primary outcome will be the number of treated fasting induced hypoglycemic events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a Randomize Crossover study with a pre-crossover phase and a crossover trial phase, which will include a minimum of 20 participants and consist of two (2-weeks) periods.
| Arm | Type | Receives |
|---|---|---|
| Glucagon injection | Experimental | Drug: Glucagon InjectionDilute Glucagon (1 mg/ml) |
| Glucose tablets | Active comparator | Other: Glucose TabletsDextrose glucose tablets |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- Clinical diagnosis of T1DM using daily insulin
- 18.0 to < 65.0 years of age with body mass index 20.0 to <35.0 kg/m2.
- Having diabetes for ≥2.0 years
- HbA1c <8.5%
- Has a smart phone with access to the internet and welling to upload data during the study period.
Key exclusion criteria (10 listed)
- Any history of more than one severe hypoglycemic episode (need assistance by third party) in the past 12 months
- Any history of more than one episode of diabetic ketoacidosis in the past 12 months
- Female pregnant or planning to get pregnant.
- Use of any of the following medications: oral hypoglycemic agents, systemic corticosteroids or beta-blocker, theophylline, beta-adrenergic agonists, 1st generation anticholinergic drugs.
- History of hypersensitivity to glucagon or severe hypersensitivity reactions (such as angioedema) to any other medications
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 |
|---|---|---|
| Glucagon InjectionParticipants will be instructed to check their blood glucose (BG) with study meter once they developed hypoglycemia symptoms, their CGM reads below 70 mg/dl, or when the CGM glucose was trending down and the participant intended to treat to prevent hypoglycemia. Participants will be instructed to check BG with meter 3 times and treat the hypoglycemia event using mini-dose glucagon when their BG in range 40-69 mg/dl according a prescribed protocol. | Drug | Glucagon injection |
| Glucose TabletsParticipants will be instructed to check their blood glucose (BG) with study meter once they developed hypoglycemia symptoms, their CGM reads below 70 mg/dl, or when the CGM glucose was trending down and the participant intended to treat to prevent hypoglycemia. Participants will be instructed to check BG with meter 3 times and treat the hypoglycemia event using glucose tablets when their BG in range 40-69 mg/dl according a prescribed protocol. | Other | Glucose tablets |
Primary outcome
Changes in glucose values from baseline to 30 minute
Time frame: 30 minutes
The change in blood glucose from baseline to 30 minute following treatment of hypoglycemic events
19 secondary outcomes
Events approached 100 mg/dL or increased by 30 mg/dL
Time frame: 60 Minutes
Treatment success from first dose
Time frame: 60 Minutes
Mean Glucose Value, during hypoglycemia event by CGM
Time frame: 60 Minutes
Time in Range, during hypoglycemia event by CGM
Time frame: 60 Minutes
Time spend below 70 mg/dL, during hypoglycemia event by CGM
Time frame: 60 Minutes
Minimum Glucose, during hypoglycemia event by CGM
Time frame: 60 Minutes
Maximum Glucose, during hypoglycemia event by CGM
Time frame: 60 Minutes
Mean Glucose Value, during hypoglycemia event by CGM
Time frame: 120 Minutes
Time in Range, during hypoglycemia event by CGM
Time frame: 120 Minutes
Time spend below 70 mg/dL, during hypoglycemia event by CGM
Time frame: 120 Minutes
Minimum Glucose, during hypoglycemia event by CGM
Time frame: 120 Minutes
Maximum Glucose, during hypoglycemia event by CGM
Time frame: 120 Minutes
The proportion of completion of fasts
Time frame: 2 Weeks
Mean Glucose Value, by CGM
Time frame: 2 Weeks
Time in Range, by CGM
Time frame: 2 Weeks
Time spend below 70 mg/dL, by CGM
Time frame: 2 Weeks
Time spend above 180 mg/dL, by CGM
Time frame: 2 Weeks
Time spend above 250 mg/dL, by CGM
Time frame: 2 Weeks
Coefficient of Variation, by CGM
Time frame: 2 Weeks
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 15 Jul 2021.
- Derived from this study: PubMed 35176134Algeffari M, Hussain S, Almogbel T, Alsharidah M, Alghadouni H, Mahmood F. Home Use of Mini-Dose Glucagon As a Novel Treatment for Hypoglycemia Following Repeated, Prolonged Fasts in Type 1 Diabetes During Ramadan. Diabetes Care. 2022 Apr 1;45(4):990-993. doi: 10.2337/dc21-1655.
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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?
A study testing Glucagon Injection and Glucose Tablets in people with Fasting Hypoglycemia and Diabetes Mellitus, Type 1, run by Qassim University at 1 site in Saudi Arabia.
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 9 inclusion and 10 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 15 Jul 2021. 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 Saudi Arabia. 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?
Changes in glucose values from baseline to 30 minute (time frame: 30 minutes). 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 NCT03970772, 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 15 Jul 2021.