Clinical trial NCT03970772: Mini-Dose Glucagon to Treat Fasting-induced Hypoglycemia During Ramadan
Official title: Mini-Dose Glucagon to Treat Fasting-induced Hypoglycemia During Ramadan
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fasting Hypoglycemia
Diabetes Mellitus, Type 1
Keywords: Type 1 diabetes mellitus
Fasting
Ramadan
Glucagon
Mini-dose
Hypoglycemia
Lead sponsor: Qassim University
Sponsor class: OTHER
First posted: 2019-06-03
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 64
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention 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.
Primary purpose: TREATMENT

Brief summary: 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:

1. Pre-crossover Phase:

   Before starting the crossover trial, a pre-crossover phase will conduct to evaluate hypoglycemia eligibility, frequency and compliance.
2. 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:

1. Group A in periods one will use MDG and glucose tablets in period two according to the protocol.
2. 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.

Eligibility criteria: Inclusion Criteria:

1. Clinical diagnosis of T1DM using daily insulin
2. 18.0 to \< 65.0 years of age with body mass index 20.0 to \<35.0 kg/m2.
3. Having diabetes for ≥2.0 years
4. HbA1c \<8.5%
5. Has a smart phone with access to the internet and welling to upload data during the study period.
6. Welling to wear a devise such as continuous glucose monitor ≥6 days/week.
7. Females, not currently known to be pregnant
8. In good general health as evaluated by investigator based on available clinical data
9. Willing to comply to the protocol requirements for the duration of the study

Exclusion Criteria:

1. Any history of more than one severe hypoglycemic episode (need assistance by third party) in the past 12 months
2. Any history of more than one episode of diabetic ketoacidosis in the past 12 months
3. Female pregnant or planning to get pregnant.
4. Use of any of the following medications: oral hypoglycemic agents, systemic corticosteroids or beta-blocker, theophylline, beta-adrenergic agonists, 1st generation anticholinergic drugs.
5. History of hypersensitivity to glucagon or severe hypersensitivity reactions (such as angioedema) to any other medications
6. History of uncontrolled hypertension (systolic BP \>160 mmHg or diastolic BP \>100 mmHg)
7. History of seizure disorder.
8. 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.
9. Currently following any kind of weight-loss diet
10. Currently participation in another clinical trials

Primary outcomes:
measure: Changes in glucose values from baseline to 30 minute
timeFrame: 30 minutes
Secondary outcomes:
measure: Events approached 100 mg/dL or increased by 30 mg/dL
timeFrame: 60 Minutes
measure: Treatment success from first dose
timeFrame: 60 Minutes
measure: Mean Glucose Value, during hypoglycemia event by CGM
timeFrame: 60 Minutes
measure: Time in Range, during hypoglycemia event by CGM
timeFrame: 60 Minutes
measure: Time spend below 70 mg/dL, during hypoglycemia event by CGM
timeFrame: 60 Minutes
measure: Minimum Glucose, during hypoglycemia event by CGM
timeFrame: 60 Minutes
measure: Maximum Glucose, during hypoglycemia event by CGM
timeFrame: 60 Minutes
measure: Mean Glucose Value, during hypoglycemia event by CGM
timeFrame: 120 Minutes
measure: Time in Range, during hypoglycemia event by CGM
timeFrame: 120 Minutes
measure: Time spend below 70 mg/dL, during hypoglycemia event by CGM
timeFrame: 120 Minutes
measure: Minimum Glucose, during hypoglycemia event by CGM
timeFrame: 120 Minutes
measure: Maximum Glucose, during hypoglycemia event by CGM
timeFrame: 120 Minutes
measure: The proportion of completion of fasts
timeFrame: 2 Weeks
measure: Mean Glucose Value, by CGM
timeFrame: 2 Weeks
measure: Time in Range, by CGM
timeFrame: 2 Weeks
measure: Time spend below 70 mg/dL, by CGM
timeFrame: 2 Weeks
measure: Time spend above 180 mg/dL, by CGM
timeFrame: 2 Weeks
measure: Time spend above 250 mg/dL, by CGM
timeFrame: 2 Weeks
measure: Coefficient of Variation, by CGM
timeFrame: 2 Weeks
Other outcomes:
Locations:
city: Buraydah
country: Saudi Arabia
facility: Qassim University
Study officials:
References:
citation: 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.