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

Primary Purpose

Fasting Hypoglycemia, Diabetes Mellitus, Type 1

Status
Completed
Phase
Not Applicable
Locations
Saudi Arabia
Study Type
Interventional
Intervention
Glucagon Injection
Glucose Tablets
Sponsored by
Qassim University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fasting Hypoglycemia focused on measuring Type 1 diabetes mellitus, Fasting, Ramadan, Glucagon, Mini-dose, Hypoglycemia

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Qassim University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Glucagon injection

Glucose tablets

Arm Description

Dilute Glucagon (1 mg/ml)

Dextrose glucose tablets

Outcomes

Primary Outcome Measures

Changes in glucose values from baseline to 30 minute
The change in blood glucose from baseline to 30 minute following treatment of hypoglycemic events

Secondary Outcome Measures

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
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
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
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.
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.
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.
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.
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
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
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
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.
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.
The proportion of completion of fasts
The proportion of completion of fasts following treatment of hypoglycemic events
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
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
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
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
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
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

Full Information

First Posted
May 29, 2019
Last Updated
July 9, 2021
Sponsor
Qassim University
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1. Study Identification

Unique Protocol Identification Number
NCT03970772
Brief Title
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

2. Study Status

Record Verification Date
July 2021
Overall Recruitment Status
Completed
Study Start Date
April 15, 2019 (Actual)
Primary Completion Date
June 10, 2019 (Actual)
Study Completion Date
August 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Qassim University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fasting Hypoglycemia, Diabetes Mellitus, Type 1
Keywords
Type 1 diabetes mellitus, Fasting, Ramadan, Glucagon, Mini-dose, Hypoglycemia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
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)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Glucagon injection
Arm Type
Experimental
Arm Description
Dilute Glucagon (1 mg/ml)
Arm Title
Glucose tablets
Arm Type
Active Comparator
Arm Description
Dextrose glucose tablets
Intervention Type
Drug
Intervention Name(s)
Glucagon Injection
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Glucose Tablets
Intervention Description
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.
Primary Outcome Measure Information:
Title
Changes in glucose values from baseline to 30 minute
Description
The change in blood glucose from baseline to 30 minute following treatment of hypoglycemic events
Time Frame
30 minutes
Secondary Outcome Measure Information:
Title
Events approached 100 mg/dL or increased by 30 mg/dL
Description
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
Time Frame
60 Minutes
Title
Treatment success from first dose
Description
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
Time Frame
60 Minutes
Title
Mean Glucose Value, during hypoglycemia event by CGM
Description
During the first hour following each hypoglycemic event (BG 50-69 mg/dL), the investigators will calculate the mean glucose value from CGM data
Time Frame
60 Minutes
Title
Time in Range, during hypoglycemia event by CGM
Description
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.
Time Frame
60 Minutes
Title
Time spend below 70 mg/dL, during hypoglycemia event by CGM
Description
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.
Time Frame
60 Minutes
Title
Minimum Glucose, during hypoglycemia event by CGM
Description
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.
Time Frame
60 Minutes
Title
Maximum Glucose, during hypoglycemia event by CGM
Description
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.
Time Frame
60 Minutes
Title
Mean Glucose Value, during hypoglycemia event by CGM
Description
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
Time Frame
120 Minutes
Title
Time in Range, during hypoglycemia event by CGM
Description
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
Time Frame
120 Minutes
Title
Time spend below 70 mg/dL, during hypoglycemia event by CGM
Description
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
Time Frame
120 Minutes
Title
Minimum Glucose, during hypoglycemia event by CGM
Description
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.
Time Frame
120 Minutes
Title
Maximum Glucose, during hypoglycemia event by CGM
Description
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.
Time Frame
120 Minutes
Title
The proportion of completion of fasts
Description
The proportion of completion of fasts following treatment of hypoglycemic events
Time Frame
2 Weeks
Title
Mean Glucose Value, by CGM
Description
During the entire two weeks of intervention/comparator period, the investigators will calculate the mean glucose value from CGM data
Time Frame
2 Weeks
Title
Time in Range, by CGM
Description
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
Time Frame
2 Weeks
Title
Time spend below 70 mg/dL, by CGM
Description
During the entire two weeks of intervention/comparator period, the investigators will calculate the percentage of time <70 mg/dL from CGM data
Time Frame
2 Weeks
Title
Time spend above 180 mg/dL, by CGM
Description
During the entire two weeks of intervention/comparator period, the investigators will calculate the percentage of time >180 mg/dL from CGM data
Time Frame
2 Weeks
Title
Time spend above 250 mg/dL, by CGM
Description
During the entire two weeks of intervention/comparator period, the investigators will calculate the percentage of time >250 mg/dL from CGM data
Time Frame
2 Weeks
Title
Coefficient of Variation, by CGM
Description
During the entire two weeks of intervention/comparator period, the investigators will calculate the Coefficient of Variation from CGM data
Time Frame
2 Weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. 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 Exclusion Criteria: 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) 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
Facility Information:
Facility Name
Qassim University
City
Buraydah
Country
Saudi Arabia

12. IPD Sharing Statement

Citations:
PubMed Identifier
35176134
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.
Results Reference
derived

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

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