Mini-Dose Glucagon to Treat Fasting-induced Hypoglycemia During Ramadan

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

Mini-Dose Glucagon to Treat Fasting-induced Hypoglycemia During Ramadan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03970772
• Other study ID #: med-2019-2-2-I-5389
• Status: Completed
• Phase: N/A
• Start date: April 15, 2019
• Est. completion date: August 15, 2019

Study information

• Verified date: July 2021
• Source: Qassim University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study aimed to develop a new approach for the treatment of fasting induced hypoglycemia during ramadan using mini-dose glucagon.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 15, 2019
• Est. primary completion date: June 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Fasting Hypoglycemia
• Hypoglycemia

Intervention

Drug:
• Glucagon Injection
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.

Other:
• Glucose Tablets
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.

Locations

Country	Name	City	State
Saudi Arabia	Qassim University	Buraydah

Sponsors (1)

Lead Sponsor	Collaborator
Qassim University

Country where clinical trial is conducted

Saudi Arabia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes in glucose values from baseline to 30 minute	The change in blood glucose from baseline to 30 minute following treatment of hypoglycemic events	30 minutes
Secondary	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	60 Minutes
Secondary	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	60 Minutes
Secondary	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	60 Minutes
Secondary	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.	60 Minutes
Secondary	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.	60 Minutes
Secondary	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.	60 Minutes
Secondary	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.	60 Minutes
Secondary	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	120 Minutes
Secondary	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	120 Minutes
Secondary	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	120 Minutes
Secondary	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.	120 Minutes
Secondary	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.	120 Minutes
Secondary	The proportion of completion of fasts	The proportion of completion of fasts following treatment of hypoglycemic events	2 Weeks
Secondary	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	2 Weeks
Secondary	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	2 Weeks
Secondary	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	2 Weeks
Secondary	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	2 Weeks
Secondary	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	2 Weeks
Secondary	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	2 Weeks