GB2548069A - Carbohydrate composition for the management of diabetes - Google Patents

Carbohydrate composition for the management of diabetes Download PDF

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Publication number
GB2548069A
GB2548069A GB1518259.5A GB201518259A GB2548069A GB 2548069 A GB2548069 A GB 2548069A GB 201518259 A GB201518259 A GB 201518259A GB 2548069 A GB2548069 A GB 2548069A
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United Kingdom
Prior art keywords
carbohydrate
unit dose
composition according
carbohydrate composition
fructose
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Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
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Application number
GB1518259.5A
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GB201518259D0 (en
Inventor
Eugene Buchanan Paul
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Team Blood Glucose Ltd
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Team Blood Glucose Ltd
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Publication date
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Priority to GB1518259.5A priority Critical patent/GB2548069A/en
Publication of GB201518259D0 publication Critical patent/GB201518259D0/en
Publication of GB2548069A publication Critical patent/GB2548069A/en
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A—HUMAN NECESSITIES
    • A23—FOODS OR FOODSTUFFS; TREATMENT THEREOF, NOT COVERED BY OTHER CLASSES
    • A23L—FOODS, FOODSTUFFS, OR NON-ALCOHOLIC BEVERAGES, NOT COVERED BY SUBCLASSES A21D OR A23B-A23J; THEIR PREPARATION OR TREATMENT, e.g. COOKING, MODIFICATION OF NUTRITIVE QUALITIES, PHYSICAL TREATMENT; PRESERVATION OF FOODS OR FOODSTUFFS, IN GENERAL
    • A23L33/00—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof
    • A23L33/10—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives
    • A23L33/125—Modifying nutritive qualities of foods; Dietetic products; Preparation or treatment thereof using additives containing carbohydrate syrups; containing sugars; containing sugar alcohols; containing starch hydrolysates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7004—Monosaccharides having only carbon, hydrogen and oxygen atoms
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/7016—Disaccharides, e.g. lactose, lactulose
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/702—Oligosaccharides, i.e. having three to five saccharide radicals attached to each other by glycosidic linkages
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/70—Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715—Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Molecular Biology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Food Science & Technology (AREA)
  • Nutrition Science (AREA)
  • Mycology (AREA)
  • Polymers & Plastics (AREA)
  • Diabetes (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Endocrinology (AREA)
  • Emergency Medicine (AREA)
  • Hematology (AREA)
  • Obesity (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

A unit dose of carbohydrate composition comprising 15 grams of carbohydrate, optionally in admixture with one or more pharmaceutically acceptable excipients. Further the carbohydrate composition may comprise the following formulation, which includes carbohydrate in the form of a 2:1 ratio of glucose to fructose or maltodextrin to fructose; for example maltodextrin 44% w/w, water 32% w/w, fructose 22% w/w, citric acid 1.5% w/w, flavouring 0.4% w/w and potassium sorbate 0.1% w/w. The unit dose can be held in a sealed container (e.g. sachet). This invention relates to carbohydrate compositions for the management of diabetes, and in particular for the treatment of hypoglycaemic episodes in diabetes.

Description

Carbohydrate Composition for the Management of Diabetes
This invention relates to carbohydrate compositions for the management of diabetes, and in particular for the treatment of hypoglycaemic episodes in diabetes.
Diabetes mellitus, commonly referred to simply as diabetes, is a family of metabolic diseases in which the body loses its ability to properly regulate blood glucose levels. This may be as a result of either the pancreas being unable to produce enough insulin, a hormone that regulates blood glucose levels by stimulating skeletal muscles and adipose tissue to absorb excess glucose from the blood (type-1 diabetes), or the tissues of the body becoming incapable of responding to insulin, typically as a result of poor lifestyle and especially excessive bodyweight and failure to exercise (type-2 diabetes).
There are estimated to be 387 million people living with diabetes worldwide, around 90% of these having type-2 diabetes, and diabetes is estimated to result in between 1.5 and 4.9 million deaths each year. In the United Kingdom, the current cost of direct patient care for those living with diabetes is estimated to be around £9.8 billion (£1 billion for type-1 diabetes and £8.8 billion for type-2 diabetes), and this cost is projected to rise significantly over the coming years. Accordingly, improvements in the management of diabetes are highly desirable.
Management of diabetes typically involves careful control of exercise and carbohydrate intake along with administration of insulin following carbohydrate intake in order to maintain blood glucose levels within a healthy range. In particular, it is generally recommended for diabetic patients to maintain their blood glucose levels between approximately 4 mmol/l and 8 mmol/l. However, diabetic individuals are prone to hypoglycaemic episodes, in which blood glucose levels drop below the normal range, particularly as a result of taking on too much insulin, for example following an overestimation of the amount of carbohydrate being taken on in a meal or an underestimate of the amount of carbohydrate used during exercise.
Symptoms of hypoglycaemia usually start to occur at blood glucose levels of below approximately 3.0 mmol/l and include shakiness, irritability, nausea, headaches, confusion, inability to concentrate and, in more serious cases, inability to walk or speak normally. Blood glucose levels of below approximately 1.2 mmol/l generally result in unconsciousness and often call for immediate medical intervention, such as administration of intravenous glucose.
Hypoglycaemic episodes are generally self-treated by ingestion of additional carbohydrate in order to increase blood glucose levels to the normal range. The conventional advice for dealing with a hypoglycaemic episode is to take on 15 grams of carbohydrate, wait for 15 minutes for the carbohydrate to be absorbed into the blood, and then to take a blood glucose reading to confirm that the blood glucose level is returning to the normal range. This is often referred to as the “15-15 rule”. However, the precise quantities of carbohydrate from freely available sources such as confectionery and fruit juices vary significantly, often resulting in patients misjudging the quantity of carbohydrate being taken on, which produces inconsistent outcomes for each hypoglycaemic episode and the need to subsequently take insulin or additional carbohydrate in order to stabilise blood glucose levels within the normal range.
There is therefore a need for a consistent and predictable means of taking on carbohydrate in response to a hypoglycaemic episode that is convenient and fits in with the day-to-day life of diabetic individuals.
There has now been devised an improved means of treating a hypoglycaemic episode that overcomes or substantially mitigates the above-mentioned and/or other problems associated with the prior art.
Therefore, according to the first aspect of this invention, there is provided a unit dose of carbohydrate composition comprising 15 grams of carbohydrate, optionally in admixture with one or more pharmaceutically acceptable excipients.
The unit dose of carbohydrate composition of this invention comprises 15 grams of carbohydrate in order to provide a consistent dose of carbohydrate that can be taken in response to a hypoglycaemic episode and hence provide more predictable outcomes to hypoglycaemic episodes and enables easier management of diabetes.
The unit dose of carbohydrate composition may comprise 15 grams of carbohydrate to the nearest gram (ie 14.5 to 15.4 grams). However, the unit dose of carbohydrate composition may comprise 15 grams of carbohydrate to higher degrees of accuracy, such as 15.0 grams (ie 14.95 to 15.04 grams) of carbohydrate, or 15.00 grams (ie 14.995 to 15.004 grams) of carbohydrate.
The carbohydrate may be any carbohydrate that is suitable for the treatment of a hypoglycaemic episode and in particular is preferably capable of producing an increase in blood glucose within a relatively short period following ingestion. The carbohydrate is preferably capable of producing an increase in blood glucose level within 15 minutes of ingestion, more preferably within 10 minutes of ingestion, more preferably within 5 minutes of ingestion, and most preferably within 3 minutes of ingestion.
The carbohydrate preferably comprises any one or more of monosaccharides such as glucose, fructose and galactose, disaccharides such as sucrose, lactose, and maltose, oligosaccharides and relatively short chain polysaccharides, such as maltodextrin, or highly branched polysaccharides.
The carbohydrate preferably comprises at least two monosaccharides or sources of at least two monosaccharides (ie molecules that can be metabolised or digested into monosaccharides). In one embodiment, the carbohydrate comprises glucose or a source of glucose (ie a molecule comprising glucose that can be metabolised or digested into glucose), and fructose or a source of fructose (ie a molecule comprising fructose that can be metabolised or digested into fructose). Glucose and fructose at a ratio of between 1.5:1 and 2.5:1 by weight, and especially 2:1 by weight, is currently preferred as this is believed to enable the most rapid absorption of carbohydrate.
The carbohydrate preferably comprises glucose in the form of maltodextrin, which is a polysaccharide produced from partially digested starch and consists of chains of glucose that vary in length between about 3 and 20 glucose units. Maltodextrin is absorbed by the body at the same rate as glucose and is flavourless or only slightly sweet, which improves the palatability of the carbohydrate composition. Maltodextrin may also provide the carbohydrate composition with a more viscous consistency.
The carbohydrate may be derived from sources free from allergens. In particular, the maltodextrin may be derived from corn starch rather than wheat starch in order to ensure the carbohydrate composition is suitable for use by gluten-intolerant individuals.
The carbohydrate composition of this invention may be up to 100% carbohydrate by weight. However, the carbohydrate may optionally be in admixture with one or more pharmaceutically acceptable excipients. The carbohydrate may therefore be between 40% and 90% of the composition by weight, preferably between 50% and 80% of the composition by weight, more preferably between 60% and 70% of the composition by weight, and most preferably about 65% of the composition by weight. One particularly preferred excipient is water. The carbohydrate may be entirely dispersed in water, such that the carbohydrate composition is an aqueous solution.
The carbohydrate composition of this invention may further comprise one or more additives intended to improve the palatability of the carbohydrate composition. In particular, the carbohydrate composition of this invention may further comprise an appropriate flavouring, such as fruit flavouring, for example orange, strawberry or apple flavouring.
The carbohydrate composition of this invention may further comprise one or more preservatives intended to increase the shelf-life of the product and to ensure the carbohydrate remains effective after a significant period of storage. One suitable preservative is potassium sorbate.
The carbohydrate composition of this invention may further comprise one or more electrolytes such as sodium chloride, potassium chloride, calcium lactate, magnesium carbonate.
The carbohydrate composition of this invention may further comprise one or more buffers, such as citric acid, in order to maintain the carbohydrate composition at a stable pH.
The carbohydrate composition of this invention may further comprise one or more thickeners to increase the viscosity of the carbohydrate composition. Suitable thickeners include vegetable gums such as alginin, guar gum, and xanthan gum or proteins such as collagen, egg whites, furcellaran, and gelatin. The carbohydrate composition may include sufficient carbohydrate in the form of maltodextrin to provide the desired viscosity, but the carbohydrate composition must not contain any thickeners that could act as a source of carbohydrate in addition to the 15 grams of carbohydrate in each unit dose of carbohydrate composition.
The carbohydrate composition of this invention may further comprise additional additives such as caffeine or one or more vitamins (eg Vitamins C, A, B6, and/or E).
The unit dose of carbohydrate composition of this invention may take any suitable form and in particular may be a liquid, or a solid in the form of one or more tablets, a powder or granules. However, the carbohydrate composition is preferably a viscous liquid, and in particular is preferably a relatively low viscosity gel.
The unit dose of carbohydrate composition of this invention is preferably for oral administration.
The unit dose is preferably contained within a sealed container. The sealed container is preferably suitable for a diabetic individual to open by hand and administer the unit dose of carbohydrate composition to themselves during a hypoglycaemic episode. In particular, the sealed container preferably comprises a relatively simple opening means, such as a frangible seal or a screw cap.
In addition, it is preferable for as much of the unit dose of carbohydrate composition as possible to be dispensed from the sealed container such that substantially all of the 15 grams of carbohydrate may be ingested by the diabetic individual. Accordingly, the sealed container preferably enables the unit dose of carbohydrate composition to be dispensed with minimal vestiges.
The sealed container is preferably formed of a flexible material, which may allow the unit dose of carbohydrate composition to be squeezed out of the sealed container by hand. In particular, the sealed container may be in the form of two layers of flexible material joined together around their edges, such that the container may be readily squeezed flat by hand, which may enable the unit dose of carbohydrate composition to be dispensed by hand with minimal vestiges. The material of the sealed container is preferably robust and impermeable to the carbohydrate composition in order to avoid any of the carbohydrate composition escaping from the sealed container before it is dispensed. In particular, the sealed container is preferably formed of a film material, such as a plastics film or a metallised film.
The sealed container preferably includes a clear indication of the location of the point at which it can be opened in order to enable a diabetic individual to easily identify the point at which the sachet can be opened while experiencing a hypoglycaemic episode. This may include a coloured portion at or adjacent to the point at which the sealed container can be opened that contrasts with the colour of the remainder of the container.
The sealed container is preferable a sachet. The sachet is preferably elongate in order to allow it to be handled easily. The sachet preferably comprises a frangible seal. The frangible seal may comprise a notch in the material of the sachet from which the sachet can be torn open and the unit dose of carbohydrate composition dispensed.
According to a second aspect of this invention, there is provided a pack comprising a plurality of unit doses of carbohydrate composition comprising 15 grams of carbohydrate, optionally in admixture with one or more pharmaceutically acceptable excipients.
In particular, the unit doses of carbohydrate composition are preferably those of the first aspect of the invention.
According to a third aspect of this invention, there is provided a method of treating a hypoglycaemic episode in a diabetic individual comprising a step of administering to the individual a unit dose of carbohydrate composition comprising 15 grams of carbohydrate, optionally in admixture with one or more pharmaceutically acceptable excipients.
In particular, the unit dose of carbohydrate composition administered according to the third aspect of the invention is preferably that of the first aspect of the invention.
Example A carbohydrate composition comprises the following formulation, which includes carbohydrate in the form of a 2:1 ratio of maltodextrin to fructose:
Maltodextrin 44% w/w
Water 32% w/w
Fructose 22% w/w
Citric Acid 1.5% w/w
Flavouring 0.4% w/w
Potassium Sorbate 0.1% w/w
The carbohydrate composition is separated into unit doses, each comprising 15 grams of the carbohydrate, and each unit dose will be sealed within a sachet. Each sachet is formed of two sheets of flexible metallised film joined together around their edges, with a frangible portion comprising a notch in the material of the sachet.
Upon experiencing a hypoglycaemic episode, a diabetic patient will open the sealed sachet by tearing the frangible portion, and will self-administer the unit dose orally by squeezing the unit dose from the sachet directly into their mouth.
The diabetic individual will take a blood glucose reading 15 minutes after taking the unit dose of carbohydrate composition in order to confirm whether their blood glucose level is returning to the normal range of between 4 mmol/l and 8 mmol/l. An additional unit dose of carbohydrate composition may then be taken in the event that their blood glucose level is not returning to the normal range.
The experience of how each dose of the carbohydrate composition affected their blood glucose reading will enable the diabetic individual to use doses of the carbohydrate composition to deal more reliably and predictably deal with future hypoglycaemic episodes and hence more effectively manage their diabetes.

Claims (22)

Claims
1. A unit dose of carbohydrate composition comprising 15 grams of carbohydrate, optionally in admixture with one or more pharmaceutically acceptable excipients.
2. A unit dose of carbohydrate composition according to Claim 1, wherein the carbohydrate comprises any one or more of monosaccharides such as glucose, fructose and galactose, disaccharides such as sucrose, lactose, and maltose, oligosaccharides and relatively short chain polysaccharides, such as maltodextrin, and highly branched polysaccharides.
3. A unit dose of carbohydrate composition according to Claim 2, wherein the carbohydrate comprises at least two monosaccharides or a source of at least two monosaccharides.
4. A unit dose of carbohydrate composition according to Claim 3, wherein the at least two monosaccharides are glucose and fructose.
5. A unit dose of carbohydrate composition according to Claim 4, wherein the glucose is in the form of maltodextrin and the fructose is in the form of fructose monosaccharide.
6. A unit dose of carbohydrate composition according to Claim 4 or Claim 5, wherein the glucose and fructose are in a ratio of between about 1.5:1 and 2.5:1 by weight, and preferably about 2:1 by weight.
7. A unit dose of carbohydrate composition according to any preceding claim, wherein the carbohydrate is between 40% and 90% of the composition by weight, preferably between 50% and 80% of the composition by weight, and most preferably between 60% and 70% of the composition by weight.
8. A unit dose of carbohydrate composition according to any preceding claim, wherein the one or more pharmaceutically acceptable excipients includes water.
9. A unit dose of carbohydrate composition according to Claim 8, wherein the carbohydrate is entirely dispersed in the water, such that the composition is an aqueous solution.
10. A unit dose of carbohydrate composition according to any preceding claim, wherein the composition further comprises flavouring.
11. A unit dose of carbohydrate composition according to any preceding claim, wherein the composition further comprises a preservative.
12. A unit dose of carbohydrate composition according to any preceding claim, wherein the composition further comprises a thickener to increase the viscosity of the composition.
13. A unit dose of carbohydrate composition according to any preceding claim, wherein the composition is a relatively low viscosity gel.
14. A unit dose of carbohydrate composition according to any preceding claim, which is held within a sealed container
15. A unit dose of carbohydrate composition according to Claim 14, wherein the sealed container comprises a frangible seal.
16. A unit dose of carbohydrate composition according to Claim 14 or 15, wherein the sealed container is formed of a flexible material.
17. A unit dose of carbohydrate composition according to any of Claims 14 to 16, wherein the sealed container comprises a coloured portion at or adjacent to the point at which it can be opened that contrasts with the colour of the remainder of the container.
18. A unit dose of carbohydrate composition according to any of Claims 14 to 17, wherein the sealed container is a sachet.
19 A sealed container containing a unit dose of carbohydrate composition according to any of Claims 1 to 13.
20. A pack comprising a plurality of unit doses of carbohydrate composition according to any of Claims 14 to 18, or a plurality of sealed containers according to Claim 19.
21. A unit dose of carbohydrate composition according to any of Claims 1 to 18 for use in treating a hypoglycaemic episode in a diabetic individual.
22. A method of treating a hypoglycaemic episode in a diabetic individual comprising a step of administering to the individual the unit dose of carbohydrate composition according to any of Claims 1 to 18.
GB1518259.5A 2015-10-15 2015-10-15 Carbohydrate composition for the management of diabetes Withdrawn GB2548069A (en)

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GB2548069A true GB2548069A (en) 2017-09-13

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1992010947A1 (en) * 1990-12-21 1992-07-09 Olle Ljungqvist Medical Aktiebolag Beverage for preoperative intake
WO2009018166A1 (en) * 2007-07-27 2009-02-05 Nutritional Network, Inc. Exercise performance and recovery formulations
US20110278878A1 (en) * 2008-10-15 2011-11-17 Jacques Edouard Decombaz Liver glycogen synthesis

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO1992010947A1 (en) * 1990-12-21 1992-07-09 Olle Ljungqvist Medical Aktiebolag Beverage for preoperative intake
WO2009018166A1 (en) * 2007-07-27 2009-02-05 Nutritional Network, Inc. Exercise performance and recovery formulations
US20110278878A1 (en) * 2008-10-15 2011-11-17 Jacques Edouard Decombaz Liver glycogen synthesis

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
h&h DiabetesCare GmbH, 22 Jul 2015, LIQUI-FIT Eigenschaften, h&h DiabetesCare GmbH, [online], Available from: http://www.glucoflex.de/produkte/liqui-fitr/eigenschaften.html [27.06.2017] *
TorQ, 26 Apr 2013, TorQ Gel, TORQ LTD, [online], Available from: http://www.torqfitness.co.uk/nutrition/torq-gel [27.06.2017] *
Total Diabetes Supply, 18/06/2015, Elovate 15 Glucose SlimPaks, totaldiabetessupply.com, [online] Available from: *

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