Hypoglycaemic treatment adherence and the association with psychological, self‐management and glycaemic characteristics in adults with type 1 diabetes

Abstract Aim The purpose of this study was to examine adherence to hypoglycaemia treatment guidelines in adults with type 1 diabetes (T1DM). The American Diabetes Association recommends consumption of 15–20 g of glucose to treat hypoglycaemia. Overtreatment may result in poor glycaemic control and greater glycaemic variability. It is not fully understood how well T1DM adults comply with hypoglycaemia treatment recommendations. Design A secondary analysis using a descriptive comparative design. Methods Using real‐time measures over six consecutive days, we examined (a) adherence to hypoglycaemia treatment guidelines and (b) comparisons of demographic self‐management behaviour, psychological characteristics and glycaemia between adherent and non‐adherent groups. Results Findings revealed those who overtreated consumed more daily grain servings and reported higher stress and depressed mood compared with those who followed treatment recommendations. Findings suggest that hypoglycaemia treatment practices and psychological factors influencing self‐management should be assessed.

glycaemia measures (glycaemic control and glycaemic variability) between adherent and non-adherent groups. The research questions were as follows: 1. What is the adherence to hypoglycaemia treatment guidelines among those with T1DM? 2. How do demographic, self-management behaviour, psychological factors and glycaemic parameters differ between those who adhere versus those who do not adhere to hypoglycaemia treatment guidelines?

| Design
A descriptive comparative design was used. This was a secondary analysis of data from a parent study (N = 39) that sought to determine temporal associations of FOH with glycaemic variability in young adults with T1DM.

| Method
In the original study, questionnaires (demographic, self-management and psychological characteristics); measured height and weight; and haemoglobin A1C were collected at an initial visit for individuals aged 18-39, who had T1DM for at least 1 year and used an insulin pump. Insulin pump downloads, daily diary and continuous glucose monitoring data were collected over six consecutive days. Data were collected 2014-2016.
In this secondary analysis, we (a) examined adherence to hypoglycaemia treatment guidelines and (b) compared demographic data, self-management behaviour (diet, eating behaviour, insulin dosage), psychological factors (stress, depressive mood, FOH) and glycaemia measures (glycaemic control and glycaemic variability) between adherent and non-adherent groups.

| Participant characteristics
Demographic, diabetes and treatment regimen characteristics were obtained by self-report. Measured height and weight were used to calculate body mass index.

| Hypoglycaemia
Episodes of hypoglycaemia and subsequent treatments were recorded in a daily diary over six consecutive days. Participants recorded the date, time, blood glucose level, possible cause of the episode and subsequent treatment. Diaries were analysed for episodes of hypoglycaemia and associated treatment and verified with insulin pump downloads. An episode of hypoglycaemia was defined as a blood glucose level ≤70 mg/dl (3.9 mM) with or without symptoms, or <90 mg/dl (5 mM) if symptoms were present (Savard et al., 2016). Participants were categorized as adherent (those who treated with 15-20 g per ADA guidelines [2018]) or non-adherent (those who treated with <15 g [undertreatment] or >20 g [overtreatment]).  (1999)(2000)(2001)(2002) and the USDA nutrient databases and has been validated using concurrent dietary recall (Block et al., 1990).

| Self-management behaviour
Eating behaviour was obtained with the 51-item Three-Factor Eating Questionnaire (TFEQ), which measures three components of eating behaviour: dietary restraint (conscious restriction of food intake), disinhibition (emotional stress-induced eating behaviour) and hunger (dietary intake in response to hunger). The scale has been psychometrically validated (Cronbach's alpha: 0.79-0.93; concurrent validity attained) (Stunkard & Messick, 1985). Higher scores on each subscale indicate greater endorsement of each domain. Scores >7 on the restraint and disinhibition subscales indicate high levels of that characteristic (Lesdema et al., 2012).

Daily CHO intake and insulin dosage
Participants were instructed to input all CHO intake into their insulin pumps each time CHOs were ingested. Total daily CHO intake and insulin doses were downloaded from each participant's pump on Day 6.  The frequency of worries is totalled for an overall score. Worry item scores of 3 or 4, indicating that worry occurs often or very often, were used to determine the presence of FOH, as previously described (Hajos, Polonsky, Pouwer, Gonder-Frederick, & Snoek, 2014).

Glycaemic control
Glycaemic control was measured using A1C, which provides the mean blood glucose level over the previous 2-3 months. This was done by obtaining a finger stick drop of blood using A1C Now ® (Polymer Technology Systems, Inc., Indianapolis, IN).

Glycaemic variability
Glycaemic variability was derived from interstitial glucose recordings measured continuously over 6 days using a continuous glucose monitor (CGM; iPro2 ® ; Medtronic, Northridge, CA). The CGM was blinded so that participants could not view their glucose levels.
Interstitial glucose levels were recorded at 5-minute intervals, resulting in 288 readings per day. The CGM recordings were downloaded using Medtronic software and examined for trends. Glycaemic variability was calculated as the 24-hr glucose standard deviation, as previously described (Rodbard, 2009).

| Data collection
At the initial visit, participants completed questionnaires for demographic and diabetes characteristics, usual dietary patterns, usual hypoglycaemia treatment methods and psychological variables. A1C was measured, and the CGM was applied. Participants wore a CGM in their free-living environment over six consecutive days and were instructed to keep a daily diary of hypoglycaemic events over the same period. The CGM site was changed at a study visit on the third day, per manufacturer guidelines. On the sixth day, participants returned for a final visit to have the CGM removed, diaries collected, insulin pumps downloaded and compensation provided.

| Analysis
For this study, the data were screened for missing values and those cases were removed. Of the remaining 31 cases with no missing data, demographic, diabetes, self-management, psychological and glycaemic measures were examined using descriptive statistics (SPSS 24) to characterize the sample.
One participant was categorized into the undertreatment group.
Due to this small number, group comparisons were conducted using adherent and overtreatment groups only. A Mann-Whitney U test (for continuous variables) or chi-square test (for categorical variables) was used to examine the demographic, diabetes, self-management, psychological and glycaemic characteristics between these two groups. Due to the exploratory nature of this study, adjustments were not made for multiple comparisons.

| Ethics
Institutional review board approval for the protection of human subjects was obtained from the University of Illinois at Chicago.
Informed consent was obtained from each participant prior to data collection.

| Hypoglycaemia
During the 6-day period, 158 hypoglycaemic episodes were recorded by the 31 participants. All participants experienced hypoglycaemia. The mean number of episodes over the 6 days was 5.1 (SD: 3.3; range: 1-12). At the daily level, participants experienced 1-4 hypoglycaemic episodes per day (mean = 0.80 episodes/day).

| Self-management behaviour
One person (3%) undertreated their hypoglycaemic episodes, 16 (52%) were adherent and 14 (45%) overtreated. The most frequent method for treating hypoglycaemia was ingestion of candy, sugar or glucose tablets. Those who were treated in guidelines primarily used small pre-packaged candy or glucose tablets with easily identified CHO gram levels to facilitate consistent treatment. In terms of dietary patterns, the average usual dietary intake for the entire sample was comprised of 40% fat, 16% protein and 42% CHO. Mean scores on the TFEQ revealed high levels of dietary restraint (mean = 9.1 SD 5.1) and lower levels of disinhibition (mean = 6.4 SD 3.6) and susceptibility to hunger (mean = 5.8 SD 3.5).
They also ate significantly more servings from the grain group (mean = 3.1 SD 1.7 vs 5.6 SD 3.1, p = 0.022). Those who were adherent exhibited more dietary restraint, whereas those who overtreated exhibited more disinhibited eating behaviour, although these differences were not statistically significant (Table 2). Total daily insulin dose, glycaemic control and glycaemic variability were not significantly different between the groups (Table 2).

| D ISCUSS I ON
Findings indicated that overtreatment of hypoglycaemia occurred frequently among adults with T1DM. Nearly half (45%) overtreated beyond ADA recommendations and those who did consumed more grain servings than those who were adherent. Those who overtreated also had higher levels of stress and depressive moods than those who were adherent. A post hoc analysis revealed that the effect sizes between the two groups were 1.16 and 0.897, respectively, to detect a difference in each: (a) stress; (b) depressive mood; and (c) grain intake.
The prevalence of overtreatment is consistent with previous studies that observed overtreatment in 39%-78% of participants (Banck-Petersen et al., 2007;Larsen et al., 2006;Savard et al., 2016). We did not observe age or gender differences as did Banck-Petersen et al. (2007) and Savard et al. (2016), respectively; however, our sample was mostly young and female.
As expected, those who were adherent participated in more dietary restraint and those who overtreated showed more disinhibited eating behaviours. Disinhibition is a stress-induced eating style where heightened stress and emotion contribute to overconsumption of food. It is closely associated with weight gain in the general population (Lesdema et al., 2012), overeating in women with type 2 diabetes (van de Laar et al., 2006) and emotional distress in women with T1DM (Martyn-Nemeth, Quinn, Hacker, Park, & Kujath, 2014). The stressors associated with food intake among those with T1DM are considerably different from in the general population, particularly as they relate to treatment of hypoglycaemia; thus, they require further investigation. Greater total CHO intake was seen in the overtreatment group both on the FFQ and daily diary of CHO intake. If persistent, this behaviour could lead to greater weight gain over time.
What our study adds to the existing body of literature is the role of stress in overtreatment practices. FOH is a major stressor among persons with T1DM (Vallis, Jones, & Pouwer, 2014). In our sample, 77% experienced elevated FOH and 39% experienced generalized stress that was above the normed mean for the general population.
The high level of FOH across groups may explain why we did not see a statistically significant difference in the overtreatment group; FOH likely affected both groups.
Stress has been linked with diabetes self-management practices. Boden and Gala (2018)

| CON CLUS ION
In summary, adults in this study experienced a high frequency of hypoglycaemia and nearly half of the participants overtreated the hypoglycaemia. Findings suggest that treatment practices and psychological factors influencing hypoglycaemia self-management should be addressed and investigated further.
It is important to assess the frequency and severity of hypoglycaemia episodes among adults with T1DM. Asking patients to maintain a diary to track the frequency, cause and treatment of hypoglycaemia may facilitate strategies to improve hypoglycaemia treatment practices when indicated and to support and reinforce behaviours when appropriate. Because stress and negative mood were linked with overtreatment, it would be important to evaluate stress levels and coping strategies used to address diabetes-related concerns, and general life stress. The use of a stress-induced eating style is also important to evaluate because it has been linked with weight gain and poor health outcomes. Consideration should be given to the possible links between the frequency of hypoglycaemia and meeting glycaemic targets. Our findings suggest that attempts to meet glycaemic targets may increase hypoglycaemia events.