Defining the Niche: Just go through the door.

[peppy]

AMERICAN ASSOCIATION OF CLINICAL ENDOCRINOLOGISTS AND
AMERICAN COLLEGE OF ENDOCRINOLOGY –
CLINICAL PRACTICE GUIDELINES FOR DEVELOPING
A DIABETES MELLITUS COMPREHENSIVE CARE PLAN – 2015

4.Q6. How is Hypoglycemia Managed?
4.Q6.1. Definition
The classical definition of hypoglycemia in patients
with DM is a low blood glucose level accompanied by
symptoms of hypoglycemia (e.g., palpitations, hunger;
see section 4.Q6.2) that are relieved by the ingestion of
glucose (i.e., the Whipple triad) (178 [EL 4; review NE]).
However, hypoglycemia may be asymptomatic, and any
blood glucose <70 mg/dL is generally considered hypoglycemia.
Severe hypoglycemia is defined as any low blood glucose
event that requires assistance from another person to
administer carbohydrates or glucagon or take other corrective
action.

4.Q6.6. Management
Hypoglycemia is the primary limiting factor in the
treatment of both T1D and T2D. It remains a significant
barrier in terms of treatment adherence and achievement of
glycemic goals (166 [EL 4; NE]).
Long-term management of hypoglycemia depends on
appropriate adjustment of therapy to prevent hypoglycemia
or reduce its frequency and severity in patients prone
to hypoglycemia (e.g., the elderly and patients with T1D).
In T2D, hypoglycemia typically occurs in association with
use of exogenous insulin, sulfonylureas (especially glyburide)
(189 [EL 1; MRCT]), and glinides; symptoms may
be mild, moderate, or severe. The risk of hypoglycemia
may be further increased by the addition of other antihyperglycemic
agents to sulfonylureas or insulin. Therefore,
in adults with T2D, treatment strategies should emphasize
classes of pharmaceutical agents that are not associated
with severe hypoglycemia, many of which are available
(Table 9). Also, the role of hypoglycemia must be considered
in determining ideal A1C goals for each patient. These
issues are reviewed in the AACE algorithm for T2D

FROM www.fda.gov/downloads/advisorycommittees/committeesmeetingmaterials/drugs/endocrinologicandmetabolicdrugsadvisorycommittee/ucm390865.pdf

8.3 Hypoglycemia in Both Types of Diabetes Mellitus
Both T1DM and T2DM subjects on TI experienced lower incidence and event rates of
hypoglycemia compared with subjects on an insulin comparator. This hypoglycemia
advantage for TI-treated subjects was maintained throughout the treatment period and
remained when hypoglycemia rates were adjusted for attained HbA1c levels.

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(like the song, you have to go through the door.)

[compound26]

Here is a real example for a niche:    (How many niches like this can Afrezza have?)

How to bolus for a mid-meal decision to eat more than planned

Here is the question posed in that thread:

"If i pre-bolus for my intended meal and then begin eating, but somewhere during that meal, i decide i want to eat more (carbs,etc.) , do i need to pre-bolus (and wait again before eating the extra food) or can i just bolus and continue eating the additional food intake?

please share your experiences. thanks"

Here is a comment in that thread:

"I follow the KISS protocol. (Keep it simple, stupid) lol. Just add the appropriate amount additional insulin and enjoy your meal. If you're getting off into unfamiliar territory with foods you're not sure about, do an additional bg test or two after eating just to make sure you're on track and adjust if necessary.

Btw this is where afrezza REALLY shines because I don't take afrezza until 20-25 minutes after eating. With a big meal I'll take one dose at 20 minutes and the second at 40. The ability to eat now and dose later and still have great control is very liberating to me."

[peppy]

All type 1's over 18 years of age (USA) on insulin could make a case for Afrezza to reduce hypoglycemia.
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Couldn't this be advertised? "TI experienced lower incidence and event rates of
hypoglycemia compared with subjects on an insulin comparator."

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added: guess not

Low blood sugar (hypoglycemia) is one of the most common side effects of insulin, including Afrezza®, which can be serious and life-threatening. Common symptoms of hypoglycemia are dizziness or light-headedness, sweating, confusion, headache, blurred vision, slurred speech, shakiness, fast heartbeat, anxiety, irritability or mood change, or hunger. It may cause harm to your heart or brain. It is important for you to understand how to manage the use of Afrezza®, and to understand how to lessen the risk of hypoglycemia events.

The most common side effects of Afrezza® include low blood sugar (hypoglycemia), cough, sore throat, headache, diarrhea, tiredness, and nausea