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

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

Study Overview

• Status: Completed
• Conditions: Diabetes Mellitus, Type 1; Fasting Hypoglycemia
• Intervention / Treatment: Drug: Glucagon Injection; Other: Glucose Tablets

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.

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Saudi Arabia
  • Buraydah, Saudi Arabia
    • Qassim University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Glucagon injection; Dilute Glucagon (1 mg/ml)	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.
ACTIVE_COMPARATOR: Glucose tablets; Dextrose glucose tablets	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
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
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
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
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
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
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
The proportion of completion of fasts	The proportion of completion of fasts following treatment of hypoglycemic events	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	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	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	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	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	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	2 Weeks

Collaborators and Investigators

• Sponsor: Qassim University

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 15, 2019
• Primary Completion (ACTUAL): June 10, 2019
• Study Completion (ACTUAL): August 15, 2019

Study Registration Dates

• First Submitted: May 29, 2019
• First Submitted That Met QC Criteria: May 29, 2019
• First Posted (ACTUAL): June 3, 2019

Study Record Updates

• Last Update Posted (ACTUAL): July 15, 2021
• Last Update Submitted That Met QC Criteria: July 9, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Hypoglycemia; Fasting; Glucagon; Type 1 diabetes mellitus; Ramadan; Mini-dose
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Hypoglycemia; Physiological Effects of Drugs; Gastrointestinal Agents; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Glucagon
• Other Study ID Numbers: med-2019-2-2-I-5389

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No